Dr. Els Adriaens
After obtaining her PhD at the
University of Ghent (Belgium), Dr. Adriaens has been working as a consultant in
statistics for several major pharmaceutical companies in the preclinical as well
as in the clinical department.
Prof. Karel Allegaert
Karel Allegaert graduated from the University Leuven, Belgium in 2000 as paediatrician-neonatologist. After an additional training at Sophia Children’s Hospital in Rotterdam, he was appointed as clinical consultant neonatology at the University Hospitals Leuven. After his PhD thesis on neonatal analgesia (2002-2005), he further developed his clinical research in the field of neonatal pain treatment and developmental pharmacology in neonates and was appointed as associated professor at the same university (2005-ongoing). His current clinical research is supported by a grant of the national research council (Fund for Scientific Research, Flanders (Belgium) by a Fundamental Clinical Investigatorship (1800209 N, 2008-2012). This clinical research resulted in about 140 papers published in international peer reviewed journals, conferences proceedings and book chapters and was recently (2009) the Galenus price for research in clinical pharmacology and the Govaerts price for clinical toxicology of the Royal Academy of Medicine of Belgium.
Dr. Jean-Michel Auger
Having a background in Clinical Development, Clinical and Vigilance audits and inspections, completed by a Chief Medical Officer position, Jean-Michel is also involved in French and International lectures.
Jean-Michel worked as an independent consultant and a Manager of clinical, vigilance and medical affairs departmental staffs.
Jean-Michel keeps working with pharmaceutical groups, Competent Authorities, and medical colleges.
Mr. Vincent Baeyens
Vincent Baeyens is a recognized expert with 20+ years of experience in global Research and Development of innovative ophthalmic medical devices and drugs, including formulation, preservative-free products and technologies, stability, nonclinical studies and clinical development programs.
He is currently Senior Director of Clinical Operations EMEA at Santen.
He holds a Pharmacist degree from the University of Louvain in Belgium and has achieved a PhD in Pharmaceutical Sciences, ophthalmology at the University of Geneva on the development of topical bioadhesive ophthalmic drug delivery systems.
He was Associate Director Ophthalmology R&D at TRB Chemedica International SA, where he led the global Research and Development division of Ophthalmology.
He has published several articles in peer-reviewed journals.
Recently he won the Laureate of the Santen Global R&D Award – 2017 for his achievements in the uveitis program.
Finally, he developed and implemented the Santen competency framework with the clinical operations function.
Dr. Brendan Barnes
Brendan Barnes joined EFPIA in 2002 to work on the alignement of national laws in new member states during the enlargement of 2004 . Subsequently, he has been involved in EFPIA's work on multilateral trade and intellectual property issues, including the EU's legilslation on product diversion and compulsory licensing and on issues relating to access to medicines. More recently, he has been involved in the development of new business models in the areas of neglected disease and infection. He previously worked in the pharmaceutical industry for years, in a range of roles including Finance, Strategic and Public Affairs, among other things coordinating work on the Montreal Protocol phase-out of CCFC's. In the course of his career he has also worked in a number of other industries in a range of finance roles.
He has a degree in Psychology adn Business.
A UK national, he is marriedwith two children.
Mr. David Baugnies
David Baugnies is working for GSK Vaccines since 2008 in the Capacity and Resource management department.
His responsibilities are related to the identification, selection and management of suppliers and contracts done for GSK Vaccines clinical operational teams worldwide. In his role he is also ensuring that external supplier relationships are optimally managed across the portfolio of projects/studies.
Previously, D. Baugnies worked 12 years in the CRO and pharmaceutical industry. Prior to joining GSK Vaccines, D. Baugnies, worked as Director Global Clinical Development for Kendle in Belgium. In that role he was accountable for the success of the Operating Unit's business as well as the successful completion of projects managed out of Belgium. D. Baugnies research experience, which spans Phase II-IV clinical trials, includes study design and implementation, data management, clinical monitoring, and global project and program management. Mr. Baugnies received his B.S. in Toxicology from Louvain Catholic University in 1994.
Ms. Donna Berk
Donna Berk, M.S. serves as President of Emericlin, a clinical research staffing firm. Her ability to match client needs with the best clinical research professionals stems from her overall industry responsibilities of recruitment, retention, and development of Clinical Research Associate (CRAs) and Project Managers (PMs) as well as developing and implementing training programs. Helping clients ensure the best team is in place with realistic projections is a result of her strategic planning for project management and CRA field operations for companywide resource allocation in a CRO environment. Prior to starting Emericlin, Ms. Berk served as the United States Country Manager for Harrison Clinical Research and served as the Chief Operating Officer and Senior Director of Clinical Operations at Clinsys Clinical Research, Inc. She has over twenty years of experience in pharmaceutical product development. She has monitored and/or managed clinical trials in a variety of therapeutic areas, including oncology, respiratory, pediatric pulmonary hypertension, and analgesia. Prior to working in clinical research, Ms. Berk was a research and education coordinator as well as a product manager in the medical device industry. She holds a Bachelor’s Degree from the University of Pennsylvania and Master’s Degree in Applied Anatomy and Physiology from Boston University.
Prof. Yvonne-Béatrice Boehler
Yvonne-Beatrice is a methodologist – with profound expertise in evidencebased medicine, market access (HTA, reimbursement, [biometric] methods), clinical trial design and evaluation. She was trained as a physician, with an MD from Cologne University (Germany). In addition she obtained a master degree in business administration (MBA Health Care Management) from the European Business School (EBS University of Business and Law), Wiesbaden (Germany). Since 2014 she is Professor for Pharmamanagement and since 2016 Vice Dean for Science and Knowledge Transfer of the Faculty of Applied Natural Sciences at TH Köln (University of Applied Sciences).
Dr. Hugues Bogaerts
Hugues Bogaerts, an MD from Ghent University (1981), has been active at an international level in BioPharmaceutical industries including Johnson & Johnson’s, The Upjohn Company and GSK Biologicals. His involvement in vaccines for more than 20 years, covers all stages of development and commercialisation. Until recently he acted as an ambassador for vaccination and vaccines as Vice President and Senior Medical Director GSK Bio. Dr Bogaerts has now created his own company, HB Consult, providing medico-scientific advise and support to Bio-Pharma companies.
Dr. Bogaerts is a member of several international scientific and professional associations, and a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the UK. He lectured on vaccinology at the Catholic University of Louvain and has authored many original contributions in peer-reviewed medical journals and textbooks such as Vaccines, edited by Plotkin/Orenstein/Offit.
Prof. Johan Bosmans
Prof. Johan Bosmans, MD, holds both an academic and clinical post at the University Hospital of Antwerp. He is a lecturing professor, is experienced in clinical research and is an internationally renowned cardiologist. Prof. Bosmans is a member of the medical ethics committee of the University Hospital, a board member of the Belgian Society of Cardiology and a member of the Belgian Interdisciplinary Working Group on Acute Cardiology.
Prof. Daniel Brasseur
Daniel Brasseur (born 07.06.51) is bachelor of the European School in Brussels and was graduated as a licensed paediatrician (1981) after studying medicines at the Free University Brussels (ULB). After a 3 years stay in Central Africa and 2 years as a Medical Director in Industry, he moved to the University Children’s Hospital Queen Fabiola (Belgium) and specialised in nutrition.
At the laboratory of Paediatrics and Metabolic Diseases, he built up a unit for Nutrition and Pharmacology. He studied the impact of diet and nutrition on several enzymatic systems and immune reactions. His interest in infantile research led him to chair since 1994 the Ethical Committee of his Institution (up to 2001) and to participate to the evaluation of new and innovative drugs. This naturally brought him to take part in his National Drug Commission as an evaluator and further (1997) as a co-ordinator of the team of medical assessors at the Federal Ministry of Public Health. He continued his activities and moved to the Federal Agency for Medicines and health products ( FAMHP) when this body was created (January 2007).
He joined CPMP in 1997 at the European Medicines Agency (EMA, London) and
was elected chair in 2001 up to 2007. He was also the
Chair of the CHMP-Paediatric Expert Group and a member of the CHMP-Vaccine
Expert Group at the same Agency. Later in 2007 he became chair of the Paediatric
Committee (PDCO) at the EMA and was re-elected in 2010 for a second
non-renewable mandate. In 2013 he was re-appointed as the Belgian member at the
In his academic activities he is an Associate Professor of Paediatrics and a Professor of Nutrition at the Faculty of Medicine (Free University Brussels-ULB) and still works as a part time consultant at the University Children’s Hospital (Brussels).
He is a member of the National Council for Hygiene and of the National
He was a member of the Scientific Subcommittee on Diet and Allergy of the European Food Safety Agency (EFSA) since 2002-2005.
He is a member of several international societies in nutrition and pharmacology.
He is the author or co-author of more than 100 publications and communications in paediatrics, nutrition and infantile pharmacology.
Ms. Stefanie Broes
Stefanie Broes is a full-time doctoral researcher and fellow at the EORTC since September 2014. Her PhD project is fully supported by the EORTC and is a collaboration with the KU Leuven. At the KU Leuven, she earned both her Master of Biomedical Sciences, and she followed an additional LL.M in Intellectual Property Rights and ICT law. During her PhD project, Stefanie addresses novel models of public-private partnerships for sharing patient data and human samples. Research topics she has been working on include legal protection of medical patient data and human samples, partnership strategies, clinical oncology research, intellectual property rights, regulatory approval processes, e-health applications… Her EORTC Fellowship is supervised by Dr. Denis Lacombe (EORTC Director) and Professor Isabelle Huys of the Department of Clinical Pharmacology and Pharmacotherapy at KU Leuven as her academic advisor.
Dr. Marc Brooks
After obtaining his PhD in Biochemistry at the University of Tuebingen (Germany), Dr. Brooks worked for a consulting company in the mobile phone industry as database and middleware administrator. He also had the role as project quality manager during this time and in 2003 he moved on into the pharmaceutical industry as validation manager. He was responsible for the compliance of all computerized systems globally used in clinical development. He has been working for a syringe manufacturing company and a start-up developing a fraud protection solution. In 2008, he started as a consultant in computer systems validation, focusing on clinical development but also working in the preclinical and manufacturing area. Since 2011 he also performs vendor qualification and study audits with focus on GCP and IT, e.g. data management, biostatistics, eTMF, e-archiving.
Mr. Eric Chleide
Resource & Capacity Management, GSK Vaccines
Eric has a Ph.D. in Biology from Nihon University School of Medicine (Tokyo-Japan) & University of Namur (Belgium). Following a period of 6 years in preclinical research in the field of CNS, he has built up an impressive career of over 20 year in the Pharma and CRO environment. He joined GSK in 2007 as Head Clinical Project Management, then Director Resourcing Strategy since 2011, where he has been instrumental for the CRO/Outsourcing oversight.
Dr. Karine Clauwaert
Karine Clauwaert is a Pharmacist by training and
obtained a PhD in pharmaceutical sciences at Ghent University.
Since October 2016 Karine is director business
development at amatsiQBiologicals. AmatsiQBiologicals is a company specialized
in contract services for process development and cGMP manufacturing of
Biologicals. She scouts for new users of amatsiQBiologicals its CDMO services,
provides quotations, negotiates contracts and follows up the projects with the
Before joining amatisQBiologicals, Karine worked
for VIB, the Flemish institute for biotechnology, an academic research
institution specialized in biotechnology, as licensing manager from 2003 until
2012. In 2013 she became senior business development manager at VIB, a position
which she held until September 2015. At VIB she was responsible for proactive
marketing of the VIB technologies and for negotiating, drafting and concluding
agreements between VIB and industry, mainly research collaborations and
licensing agreements for pharmaceutical, agricultural and industrial
Before 2003 Karine was five years postdoc in the
faculty of pharmaceutical sciences at Ghent University where she was one of the
founders of a metabolomics research unit. Her specialty there was mass spectrometry
and analytical toxicology. She also worked at Micromass Europe as a product
specialist in the Benelux.
Ms. Nancy Cottigny
Nancy is the founder and Managing Director of Ad Hoc Clinical, a small CRO based in Belgium.
- Activities of the CRA from study start up to publication
- Co-monitoring and personal coaching
- How to organise study start in for various EU countries
- Clinical evaluations for In vitro diagnostics
- Solving Data privacy puzzels
- SOP making
Mr. Erwin De beuckelaer
Works at Janssen Pharmaceuticals as Director Innovative Capabilities. His mission is to bring innovation to the space of Quality & Compliance. He explores the areas of compliance training, business process management and knowledge management. Recently, he led a program to transform compliance training in Janssen R&D. He works for Janssen since 2002 in many different roles and departments across R&D and Supply Chain. His background is in communication and user experience design.
Mr. Wim De Meester
Wim De Meester's practice at Quinz focuses on national and international commercial litigation and arbitration including in the pharmaceutical, banking and insurance, telecommunications and retail sectors.
He has experience in a wide range of European and Belgian competition law litigation and advisory work and he has also published several articles in these fields.
Wim also provides regulatory advice to this retail and life sciences sector on a regular basis.
Wim De Meester started his career at Allen& Overy in , where he worked in the Antitrust & Competition law department.
He is a member of the Brussels Bar.
Mr. Tim De Schutter
Tim De Schutter holds a master’s degree in Industrial Sciences (option Biochemistry-Biotechnology) and an additional master’s degree in Cellular Biotechnology.
After obtaining his PhD in Biomedical Sciences in the Department of Microbiology and Immunology at the Catholic University of Leuven, he started working in 2014 as Inspector Medical Devices at the Federal Agency for Medicines and Health Products (FAMHP).
Dr. Jan De Witt
Dr De Witt, as a medical doctor by training, worked for pharmaceutical companies in R&D as well in marketing. Gained more than 25 years of pharma (ICI Pharmaceuticals, Zambon) and CRO experience in major players as well as smaller niche service providers (ClintrialsResearch, Quintiles, Sticares). Within the CROs being responsible for delivery of international multicentre studies, mainly Ph II-III, in Europe varying from cardiovascular, CNS and oncology; followed by more than 5 years of experience in strategic partnership development on a global basis between CRO and pharma/biotech.
Responsible for the identification and negotiation of strategic partnerships (with or without risk-investments) with pharmaceutical and/or biotech companies, mainly in the European region.
Leading to discussions on Board level with these companies, and discussions with investment companies like private equity funds, venture capitalists etc.
All these years lead to an extensive, global network among the pharmaceutical & biotech environment on executive level
Dr. Sven Deferme
After obtaining his PhD in
pharmaceutical sciences at the University of Leuven (Belgium), Dr. Deferme
has been working for several major pharmaceutical companies (Eli Lilly, UCB,
GSK) in the preclinical as well as in the clinical departments. In 2005, he
started as a consultant in medical writing. He is the author of several peer
reviewed publications, clinical study protocols and reports in the field of
vaccines, malaria, endometriosis, urology, hematology and cancer.
Ms. Heidi Deluyker
Heidi Deluyker started her career in pharma 22 years ago as a CRA at Covance. After 5 years she joined nv Roche sa to become a Country Study Manager.
In 2005 she became a line manager of CRAs at PPD where she stayed for almost 9 years. In 2014, she returned to nv Roche sa as a Business Support Leader and then moved to the Process and Training Manager role in 2016.
Mr. Bart Derre
is Managing Director of BEE Ltd.. Bart started his 25-year management career as
quality manager at a hospital. He combines management consulting, academic work
in the field of entrepreneurship education as a researcher and lecturing at
Eindhoven University of Technology and Hogeschool Gent. He is co-author of the
book: The Entrepreneurial Organization and he is a passionate student finishing
his doctoral thesis on designing effective entrepreneurship education in 2020.
Mr. Marc Devisch
Marc has a Master in Business Administration and is MBTI Certified Coach Level I and II. He works for over 20 years as a self-employed consultant, coach, facilitator. He facilitates change management as well for organisations, teams as individuals. Throughout his career Marc has covered a wide range of areas of expertise. During his former work as member of the Vlerick Management School he was able to combine a solid knowledge with active facilitation. As an “outsider” to the pharmaceutical world he can refresh the minds towards a new and inspiring successful future for your organisation. His real passions are change, conflict and influential skills and interpersonal chemistry.
Ms. Barbara Dhaene
After obtaining a PhD in Biomedical
Sciences at Ghent University in Belgium, Barbara joined the spin-off
Biogazelle. Over time she was responsible for several aspects in this fast
growing start-up; ranging from operational management, to product development,
marketing and sales.
Barbara has proven to be strong
communicator and solid project manager. She is fascinated about (digital)
innovations in healthcare and biotechnology. Since 2013, she has been
working at the consulting company Leyton, advising clients about fiscal
incentives to finance innovations.
In 2015, she founded with Nathalie Niclaus
the patient recruitment organization Akcelis.
Dr. Ann Dhoest
After obtaining here PhD in Biomedical Sciences at the University of Leuven (Belgium) and Postdoctoral research at the University of Ghent (Belgium), Dr. Dhoest worked for GlaxoSmithKline Biologicals as medical writer since 2003. In 2007, she started her own business and provides medical writing services for a broad range of clinical study documents, manuscripts, safety reports, and clinical operations. She worked in various therapeutic domains for several national and international pharmaceutical and biotech companies (GlaxoSmithKline Biologicals, Takeda, Celyad, VitalTransformation, Biomet), research institutes (Netherlands Cancer Institute, Modra Pharmaceuticals), and Clinical Research Organizations (Terminal 4 Communications, Quintiles, INC Research).She is author and contributor of several peer reviewed publications, clinical study protocols and reports in the field of vaccines, cardiovascular research, oncology, and translational sciences.
Dr. Erik Doevendans
Doevendans has over 20 years’ industry experience in CMC and a
background in quality assurance, medicinal assessments, regulatory affairs and
manufacturing operations. He started his own consultancy in 2007 and joined CNS
Biodesk as a principal consultant in 2015. Notably Erik was previously a
pharmaceutical assessor at the Dutch Medicines Board and an expert to the
Erik obtained a MSc in Pharmacy at Utrecht University, where he is still involved in the department of Pharmaceutics, with special interest in biosimilars and the relevancy of animal models used in non-clinical development.
Ms. Cathy Dove
Cathy Dove is a trusted Quality & Risk Management Industry expert, an RQA GCP Committee member and Course Tutor working within Clinical Quality Compliance and Risk Management. Cathy Dove has a wealth of Pharmaceutical Clinical Research expertise and proven track record in driving awareness and visibility of quality through quality and risk management solutions in adherence to ICH GCP E6 R2.
- Cathy has Conceptualised, Designed and Implemented proactive Quality Management models that provide Quality and Risk visualisation at the study level.
- Defined Risk Management Strategies via Data Evaluation from 1500+ Sponsor audit and Inspections.
- Evaluated Risk Based Monitoring activity compliance against ICH GCP E6 R2 for Inspection Readiness.
- Hosted / Conducted / Trained Staff in Sponsor Audits & Inspection on Global stage
- Vendor Oversight and CRO / Pharma Collaboration & Risk Management Strategy
- Regulatory Inspections & Sponsor Audits
- Complex System Audits and For Cause Audits / Investigations
Dr. Sybille Eibert
Sybille has a PhD in immunology and currently is a Senior Manager Transparency & Disclosure at Teva Pharmaceuticals International GmbH (Basel, Switzerland). Her main focus there is the implementation of new transparency requirements such as EMA Policy 0070. Between 2004 and 2016 she assumed various medical writing roles at Boehringer Ingelheim in Germany and for 1 year in China.
Dr. Carl Emerson
Starting out as a bench chemist Carl has spent all of his working life in Pharma. From the labs he moved to posts in the medical area, where he learnt what works in clinical and with project teams. He then started working in outsourcing for both clinical and procurement departments in large and small Pharma, vaccines and Biotech and in different countries; helping build and lead the function and drive innovative strategies for best practice. He has now amassed over 20 years experience in clinical oursourcing and more recently completed his executive MBA at Vlerick Business School in Belgium before moving to Switzerland and setting up InsideOut Solutions. This new company is now running entertaining training courses in many countries to share with others the benefits of his years of in-depth experience. As qualified solution-focused coach, he is passionate about people, team dynamics and creating workable answers to intractable problems.
Ms. Sini Eskola
Sini Eskola is working as Regulatory Affairs Director at European Federation of Pharmaceutical Industries and Associations (EFPIA) since Feb 2014. She has a degree in pharmaceutical sciences (MSc) from the University of Helsinki. In EFPIA her main focus areas are leading and coordinating the regulatory policy and advocacy activities on clinical trials and clinical development, pharmacovigilance, regulatory information management and environmental, health and safety aspects. She has previously worked over 5 years at AstraZeneca R&D Global Regulatory Affairs in Sweden and prior to that as an Executive Director of Finnish Pharmacists' Society. She has vast experience as practicing community pharmacist. She currently is member of the Executive Committee of Industrial Pharmacy Section of International Pharmaceutical Federation (2011-15).
Ms. Tracy Farrow
Tracy is currently Senior Director, Medical Writing for PPD where she is responsible for EMEA and APAC medical writing and PPD’s global data transparency initiative. Tracy has more than 25 years of Biomedical Science experience. Before PPD she worked for ClinTec International as Manager, Medical Writing Services; and Pfizer as Medical Writing Therapeutic Area Lead, and Quality Manager for Data Management where she was responsible for data privacy training, audit management, SOP and best practice development.
Mr. Jean Fernandez
Jean Fernandez has a degree of Engineer and a Masters Degree in Information Science and Statistics of the Faculty of Agricultural Sciences of Gembloux. He worked 7 years in academia before joining the world of pharmaceutical industry where he worked primarily Biometrics (Data Management and Biostatistics).
He worked as Project Manager and Manager of Data Management team at GSK Biologicals succesively for 7 years and then Head Global Data Management at UCB for 5 years.
He then joined the CROs world ad collaborated to the creation of the CRO 4Clinics from 2005 to 2014 as Chief Operation Officer at the CRO.
Since 2014, he used his professional experience to work as independent expert for the pharmaceutical industry and the CROs, mainly in the field of Biometrics. He has been involved in various implentation projects of clinical data anonymization tolls for the pharmaceutical industry since 2013.
Ms. Emilie Foucret
Emilie Foucret is an experienced Senior Data manager and Project Manager who joined the Pharmaceutical R&D industry in 2006. Before this date, she studied biology and obtained a specialized degree in Clinical Trials in France in 2016. She was an outsourced data manager in pharmaceutical laboratories between 2006 and April 2015 both in France and Belgium. From May 2015, she had been working in Belgium as data manager and project manager on internal projects for the CRO Keyrus Biopharma. She also became a regular trainer on data management activities at Cefochim for CLINET and Biophare programs since 2011, she is involved on technical trainings such as SQL or SAS programming.
During her career, she had the opportunity to work on clinical trials phases I to IV, from trial initiation until CSR delivery and in various therapeutics areas (osteoporosis, thrombosis, pediatrics vaccines, oncology immunotherapy, allergy, hepatology and epidemiology). Her excellent communication skills have been an asset in order to manage complex projects for pharmaceutical laboratories and biotechnologies companies. Her strong experience and technical skills are also very valuable for process improvement and training activities.
Ms. Barbara Gastl
Barbara Gastl has been working in clinical operations for 17 years. She will be able to provide valuable practical, real life advice in all areas of clinical study management and GCP. Coming from a CRA background and with CRO and sponsor experience she can shed light on all aspects of clinical operations. Her particular focus is on the creation of systems in clinical operations and on GCP compliance.
Barbara graduated with a degree in nutritional science. She has gained broad experience from managing international phase I to IV studies across a range of indications and locations. Sponsors she has been working for include well-known players in the biotech and pharmaceutical world like Biogen, Amgen and Sandoz Biopharmaceuticals. She combines her talent for team motivation with her remarkable organizational skills. Cinfa Biotech was her last main client, whom she was supporting in setting up their Quality Management System and running their pivotal clinical trial. Her current assignment is with MSD for whom she is managing oncology trials in Germany.
In her spare time she roams the fields and mountains of Europe on a historical or photographical mission.
Dr. Essam Ghanem
Essam GHANEM is an experienced physician and Qualified Person for Pharmacovigilance with almost 25 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organisations. Around 8 years working experience as EUQPPV and as consultant Safety physician in the Pharmaceutical Industry. At present time, Essam Ghanem is the Chief Medical Officer and Head of Pharmacovigilance at Vigi-Care BVBA. Membership owner of European society of CRO Federation (EUCROF).
Dr. Dirk Gillé
Dirk has 30 years of experience in the area of drug
development. Amongst other Dirk was Clinical & Compound development team
member in the dermatology franchise at the Janssen research Foundation. Later
he has set up the medical departments in CEE and ME integrating them in the
development organization. In 1999, Dirk left J&J and joined Tibotec as
Senior Director of Global Clinical Operations, creating a worldwide structure
for Clinical Operations and Quality Management. After Tibotec was acquired by
J&J, he drove the development of the New Operating Model for the newly
created GCO organization. In 2009, Dirk became the Head of Quality Management,
responsible for implementing a clinical QMS that created efficiencies and enhanced
compliance in the clinical arena for the newly created Janssen R&D
In June 2012 he became Head Pharmaceutical R&D Quality Assurance, and since January 2016 responsibilities were extended cross-sector; Pharma, MD&D and Consumer.
Dr. Marisa Giro
Dr. Marisa Giro has a sound experience in clinical research from 1986. She works with pharma companies and CROs in monitoring and auditing international clinical studies. She has experience of co-monitoring in emergent countries, where she supports sponsors during the preparation and the conduction of inspections, and the implementation of action plans. She holds training on GCP and clinical operations activities, but also courses on communication techniques and work organization. She is active at ECCRT since 2009.
Dr. Sam Hamilton
Sam Hamilton is a postdoctoral virologist and director of her UK-based medical writing consultancy. With over 24 years in clinical and regulatory medical writing roles in the pharmaceutical industry, Sam headed UK Medical Writing for a large CRO until setting up on her own in 2006. Sam has a special interest in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the openaccess
Ms. Virginie Hamtiaux
Dr. Paula Hemdal
Paula Hemdal has over 20+ years of global pharmaceutical experience (US, Europe and China/Japan) and has worked for various divisions, such as Clinical Development, Quality Assurance, Human Resources and Marketing. She has first-hand leadership experience across all the key areas of Clinical Development, starting with Investigational Site management and monitoring, protocol writing, data management and statistics, and leading departments of international Clinical Research Associates, Project Managers, and Quality Experts. She has developed training programs for CRAs, Project Managers, Medical Scientific Liaisons, and developed corporate-wide training programs and learning strategies.
Paula began her biopharmaceutical career while obtaining her Ph.D. in Psychology Research Design from Adelphi University, in New York. During her doctorate, Paula worked for the New York University Medical Center with a team of renowned Clinical Researchers in the field of Alzheimer’s Disease, Schizophrenia and Depression. She then moved into industry, starting with Rhône-Poulenc (now Sanofi), and then Pfizer in New York City. Wanting to gain more international experience, Paula moved to Belgium for UCB, to help design and implement their first global clinical trial. Paula continued working with UCB in various key roles where she helped develop UCB’s Quality Assurance Competency and Career Ladder, developed the templates for Target Product Profile and Clinical Development Plan and a Decision Point and Milestone Framework, implemented a MSL training program and developed and implemented corporate-wide GxP training programs. Having experienced 3 major mergers in her career, Paula provides first-hand experience in change management and strategy building and developing large-scale re-training programs to ensure staff acquire the competencies needed in an ever-changing biotech environment. Switching career goals and expectations towards “giving back”, Paula is now an enthusiastic and inspiring independent Freelance Training Facilitator.
Ms. Sylvie Hermans
With a Master of Industrial science and a Pedagogic Degree, Sylvie started her career at Procter & Gamble, working as a Medical Delguee. She switched to clinical research joining Quintiles, afterwards continuing working in clinical research for 20 years now.
Her job experience ranges from CRA, Lead CRA to Clinical Project Manager in CROs, pharmaceutical companies and medical device companies. The clinical trials she managed and monitored were national and international phase I to IV studies as well as observational studies in a wide of therapeutic areas.
Next to science and research, education is a pillar in Sylvie's activities. Since 2011, she provides training and coaching in the field of clinical research.
Both professional education and personal development are important. Sylvie coaches people with fear to fail, perfectionism, burn-out and she trains highly sensitive persons to valorise their talents.
Dr. Barbara Heumann
Dr. Barbara Heumann is owner and Managing Director of GXP-Engaged Auditing Services GmbH, a Munich-based audit vendor company. Dr. Heumann is a nutritionist by education, specialised in clinical nutrition of critically ill patients. After her start in academic research, she was Head of QM at Harrison Clinical Research for over 15 years, establishing an ISO 9001 compliant QM system that was certified in 1998. GXP-Engaged Auditing Services started as a company within the Harrison Holding and was acquired by Dr. Heumann in 2011 through a management buy-out. Today GXP-Engaged, with its worldwide network of 50 professionals, conducts approx. 500 audits per year in all GxP areas.
Mr. Stefan Hosten
Stefan Hosten, rolled in to Clinical Research about 23 years ago, when he joined the Research Unit Stuyvenber (part of Biopharma, now SGS Life Sciences) as a local study coordinator for pharmaceutical phase I clinical studies.
In 1997, he moved to Medisearch International (MSI, now SGS Life Sciences), where he held several positions with increasing responsibilities in various domains of pharmaceutical research (national and international Clinical Research Associate and Project Manager).
Since 2001, he exclusively works in Medical Devices Industry, again in a broad variety of positions and formats. As Senior Manager Clinical Operations, he led the clinical and technical support group at Cyberonics Europe, the market leader in Vagus Nerve Stimulation treatment for epilepsy. He also led the company's international (OUS) programs for techincal, surgical and clinical training.
Stefan is a team player with a strong multi-discipinary interest. He has built and maintained an extensive international network in the industry. This helped him in founding ClinOps consulting in the summer of 2008. Since then, he is working on clinical and technical projects for different large and start-up companies in Medical Device Industry: Cordis (J&J), Medtronic Spinal & Biologics, Medtronic Aortic & Periferal Vascular Disease Management, St. Jude Medical (Neuromodulation), Mediconsult, ECCRT, SGS Life Sciences, Neurotech (now Sorin), 3WIN (now SynapTix), Apnex Medical Inc, Protip Medical, Mainstay Medical Ltd,...
Stefan focuses his consulting services on 4 keys:
-Senior Clinical Management
-Field Clinical Engineering / Techincal support
-Training: medicla device legislation training, technical product training, surgeon trainng (office based and cadaver lab),...
Dr. Leo Huybrechts
Leo obtained his Ph.D. in Endocrinology in 1988.
He started his career in the CRO business in 1994, as Director Quality Assurance for BARC Central Laboratory, where he was responsible for the implementation of both GLP and ISO45001/ISO17025 systems in the laboratory.
In 2002, Leo moved to Omnicare Clinical Research (now Theorem/Chiltern) where he succesfully acted as account director for biotech companies, bringing in large global projects. He was also nominated as Country Manager for both the offices in The Netherlands and Belgium. Position in which he could demonstrate his managerial skills. This lead to his promotion to International Director Global Proposal Development where he lead an international team of proposal developpers situated from Australia over India to Europe.
In 2011 he moved back to BARC as Director Global Integrated Processes and later as COO Europe and Asia. In these functions Leo realized following major projects:
- Harmonization of processes and procedures in the different locations
- Selection and Set up of the China branch
- Selection and Set up of the Singapore branch
- Lead of the business team analysing and developing a new Clinical Trial Management System (Succesfully launched in 2015)
With the extension of the Belgian group within Cerba Health Care, Leo was asked in 2015 to take up the leadership of the QA department for the Belgian medical laboratories together with the global QA role for the BARC group. In this role, he succesfully guided the switch from ISO17025 to ISO15189 in the medical laboratory. He also laid the fundation of an extensive internal and external audit program covering all aspects of both ISO15189 and GCP requirements.
Prof. Isabelle Huys
Prof. dr. Isabelle Huys is pharmacist by training and with PhD in pharmaceutical sciences and further specialisation in the regulations around medicinal product development at KU Leuven.
Her research focusses on access to medicines and therapies. The research program studies diverse legal and regulatory aspects along the continuum of a medicinal product life cycle, from medicinal product discovery, development, approval, reimbursement and market adoption. The research program focuses on all types of medicinal products (small molecules, biologicals, advanced therapy medicinal products (ATMPs)). Topics include biobanking and access to (human) biological samples and data, the use of real-world data in medicinal product development, repurposing of medicines for cancer indications, patient preferences in medicinal product development, precision medicine and companion diagnostics, off-patent strategies of biological products and market access of biosimilar and drug shortages. Isabelle Huys supervises PhD projects in this research program and publishes the research in diverse journals.
Mr. Massimo Ildebrando
Massimo Ildebrando, biologist, has got a vast and solid experience in Pharma Industry working in several Pharma Companies and CROs. 25 years ago, he started his career as Scientific Representative of Pharmaceutical Products. Then, moving to the Clinical Development, he covered the positions of CRA, Lead CRA, PM and Director Project Management. As PM he was responsible for managing Phase I-IV clinical trials across Europe, Africa and Asia. He is currently Director Clinical Operations and Country Leader at SynteractHCR.
Dr. Walter Janssens
Walter Janssens obtained a PhD at the University of Antwerp
and later did research at the University
of Leuven. Then he became
research scientist in pharmaceutical industry (Janssen Pharmaceutica) with main
emphasis on cardiovascular and gastrointestinal physiology and pharmacology.
From 2002 until May 2006 he worked on toxicological aspects of the use of
industrial chemicals in a regulatory context at the Scientific Institute of
Public Health in Brussels.
From May 2006 he became senior assessor of preclinical aspects in clinical
trial applications at the department R&D of the Federal Agency for
Medicinal and Health Products. He was alternate CHMP member from February 2012
until July 2013. As alternate SAWP member he is involved since 2007 in European
scientific advice procedures. He is coordinator for early phase development at
Ms. Angelika Joos
Angelika is responsible for Regulatory Policy issues within Merck Sharp & Dohme's Global Regulatory Affairs department since 2001 and heads the EU office in Brussels. Over the past 18 years, she has gained strategic as well as operational experience with all regulatory procedures and various products in different therapeutic areas.
In her current position as Executive Director, Global Regulatory Policy she is responsible for monitoring and implementing Regulatory Policies & Procedures and advising the company on Regulatory strategies. In this capacity she oversees activities in Europe, Middle East, Africa and Asia-Pacific and actively identifies opportunities that align with MSD's business priorities.
She has over 15 years experience of working with various trade associations and professional organsations. At EU level she represents MSD in various Committees of EFPIA and EuropaBio and Regulatory & Technical Policy Committee. She was member and later chair of the DIA Advisory Council Europe from 2008-2015 and has become a DIA Board member in 2014. Her main interests are related to clinical trials, HTA, paediatrics and patient involvement.
Prof. Koen Kas
Koen Kas is a healthcare visionary driven by the aim to make healthcare delightful, personalised, and ultimately preventive. He recently published his vision in a book (Nooit meer ziek, “Sick no more”), describing how we will evolve to such future. As founding CEO of InBioVeritas and Healthskouts and Partner at Healthstartup, he ideates and facilitates innovative disruptions in healthcare, organises hackatons, and creates novel digital health startups. He serves on the Scientific Advisory Board of a large number of life sciences companies & investors. Healthskouts helps corporates to unlock unknown unknowns, via an expert-curated, self-learning newsletter with innovation & business development suggestions & insights. These sprout from the latest research & technology breakthroughs, emerging startups, design ideas and business models from within & outside of healthcare.
Before, Koen spent 15 years in Executive positions at 4 leading biotech companies, combining that with academic cancer and omics research. As CSO Oncology of Thrombogenics he spun out Oncurious, which recently obtained it’s IND to start clinical trials with a pediatric brain tumour drug. Koen was earlier founding CEO & CSO of Pronota, a company committed to better diagnosis and personalized medicine in the areas of ovarian cancer, preeclampsia, cardio-renal failure & sepsis. He was, prior to that Director drug discovery at Galapagos, one of the leading European life-sciences companies. Previously, he set up and directed the Cancer drug discovery program at Tibotec (now Johnson & Johnson).
Koen is professor Molecular Oncology at the University of Ghent, Belgium, and chairs the scientific committee of the European Cancer Prevention Organisation.
Mr. Shalabh Kumar
A proven business leader in strategy consulting and outsourcing with 25 years of experience.
Global Head of Outsourcing Services at Navitas, www.navitas.net, domain experts in the areas of Clinical, Regulatory, Safety and Compliance. Capabilities include industry leading networks, strategic and change management consulting, technology and functional outsourcing.
Director of oNirvana, www.onirvana.com, which provides expert advice and corrective action on outsourcing strategy, helping clients realise the full benefits of outsourcing.
Co-founder and CEO of Kinapse, a UK-based life sciences consulting and outsourcing services provider. Led the business from inception to a successful global business with operations in London (UK), Philadelphia (US) and Gurgaon (India). Kinapse provides consulting and outsourcing services mainly to pharmaceutical companies in clinical development, medical affairs, regulatory, safety and market access.
Strategy consultant with Accenture, London. As a senior manager, led a number of organisational and operations strategy projects for global pharmaceutical clients. Projects included advisory projects in organisation design, process design, resource management, outsourcing and performance management.
MBA from Indian Institute of Management (IIM), the top business school in India, and Bachelor of Technology (Mechanical Engineering) from Indian Institute of Technology (IIT).
Dr. Tine Laethem
Tine heads the European Translational Pharmacology department of Merck Sharp & Dohme's. In her current position as head of TP Europe, she is responsible for the Early Stage Development portfolio within the Translational Medicine department. Over the past 15 years, she has gained strategic as well as operational experience with all regulatory and operational aspects of early drug development in different therapeutic areas.Previously Tine worked for 3 years in the project management division of Janssen Research Foundation. She graduated from the University Leuven as Pharmacist, obtained a PhD at the Heymans Institute for Clincal Pharmacology, and a post-graduate degree in European Business Administration. She is a member of several professional organizations including member of the clinical trial task force of pharma.be and serves as scientific expert in different government task groups on biomedical research.
Dr. Ann Lampo
Lampo, DVM, is the EU Head of Preclinical Project Development within the
department of Preclinical Development and Safety at Janssen R&D.
Ann obtained the degree of Doctor in Veterinary Medicine at the University of Ghent Belgium in 1987. She was certified in European Regulatory Affairs at the Institute for Pharmaceutical Business Administration in the Netherlands (1996) and is a Eurotox Registered Toxicologist since 1998.
joined Janssen in 1988 as a Scientific writer. In 2000, she was appointed
Director in Toxicology and became more broadly involved in Preclinical
Development (PCD) projects, which led to the approval of a few compounds within
the Neuroscience space.
As a member of several Early Development teams, she was responsible for the toxicological contribution of more than 50 First-in Human packages.
Since 2007, Ann is the Therapeutic Area Point of Contact for Neuroscience, Infectious Diseases including Vaccines, and Global Public Health. In this function, she heads up the Preclinical Project Leaders group based in Beerse. This team also provides Preclinical Submission support for projects from NS, IDV and GPH.
Ms. Sarah Lehmann
Sarah obtained a master degree in drug discovery and development (M.Sc.) from TH Köln (University of Applied Sciences) and University of Cologne in 2018. She completed her thesis at Grünenthal (Aachen, Germany) under the supervision of Prof. Yvonne-Beatrice Böhler, MD, MBA and Dr. René Allard. The M.Sc. work has been accepted for an ISPOR presentation entitled “The EMA Clinical Data Website: A Conceptual Exploratory Approach To Benchmark Clinical Development Indicators In Marketing Authorizations” at the European Annual Meeting in Barcelona November 2018.
Ms. Liesbeth Lemmens
Liesbeth Lemmens holds a bachelor’s degree in Nursing and obtained a master’s degree in Medico-Social Sciences at the Catholic University of Leuven.
Her professional experience is a mix of 20 years working in clinical research, as a clinical trial coordinator, project manager and CRA (oncology, cardiology and IBD).
In 2010, she started to work as an independent consultant for health care providers.
Mrs. Lemmens is also key opinion leader in educating health care providers, clinical research associates, clinical trial assistants and (data) managers on different topics, such as:
- ICH-GCP in daily practice
- Audit and inspection readiness
- Train the trainer
- Time management in clinical research
- Developments and therapies in oncology
She teaches in terms of the most-up-to-date knowledge delivered in an accessible and informative fashion, with constant updating of training materials.
As a facilitator and moderator, she uses a wide range of skills and tools, from problem solving and decision making, to team and time management, coaching and communications.
Ms. Anne Lenaers
Pharmacist Anne Lenaers obtained his degree in Pharmaceutical sciences from the University of Liège, Belgium in 1992. Between 1992 and 2001 she worked as the titular of an Officine open to the public in Liège.
Since 2001 she has been working for the Federal Agency for Medicines and Health Products (FAMHP), which is the competent authority in Belgium for medicinal products and Health Products (Medical Devices, Human Body Material and Blood Products) and which is working as the administration of the Ministry of Health in these matters.
She first worked one year in the Inspection pillar of the agency and then she moved to the DG pre pillar of the FAMHP working first 2 years in the division dealing with the Marketing Authorisation dossiers and since 2004 in the Research & Development division of the FAMHP.
She was the secretary of the CTFG workgroup of the Heads of Medicines Agencies from 2008 until 2011 and is responsible of the CTA initial trials unit in the R&D division since 2013.
Ms. Martine Lewi
Tine Lewi is a Scientific Director within Janssen Global R&D,
Quantiative Sciences / Real World Evidence, Medical Affairs and Established
Products statistics. She has worked for over 15 years in the area of innovative
solutions for health data and insight generation. Tine has a background in
medical informatics, as well as in applied economics and currently leads
workstreams in two major European-wide initiaves, the IMI / European Medical
Informatics Framework (EMIF) project and the InSite Champion Program, a follow
on project of the IMI / European Medical Records for Clinical Research (EHR4CR)
initiative. Tine also has a research background in health consumer research and
Dr. Bodo Lutz
Bodo Lutz holds a leading role as an expert for global clinical Data Integrity and Risk Management, and also supporting decentralized trials within a global pharmaceutical company. In this position he is an alliance manager for multiple partners ranging from clinical operations to external parties, as well as scouting and evaluating opportunities to improve Data Governance and Risk Management.
He has 15+ years of experience in the quality environment in the pharmaceutical industry. He held several positions in clinical Quality Management functions at CROs, Biotech, Medical Device and Pharmaceutical companies.
He is a lecturer for an Austrian university and has spoken at numerous international conferences and workshops on Data Integrity and Risk Management topics.
Bodo Lutz, a Germany native, is an environmental engineer and marine biologist by education and received his doctorate of natural sciences (PhD) from the Technical University of Munich, Germany.
Dr. Kim Luyckx
Kim Luyckx (PhD, MA) is a clinical research informatics project manager at the Antwerp University Hospital. After seven years of scientific research and completing a PhD in computational linguistics, Kim transitioned into the healthcare sector to valorize scientific results from the fields of text mining and machine learning. During the past six years in the hospital, she has mainly focused on use cases concerning secondary use of real-world clinical data, hereby strengthening her expertise in medical informatics and clinical data science. She offers data management advice for (investigator-led) clinical trials, is product manager of several research-related IT products, and is involved in various strategic and innovation projects at the Antwerp University Hospital. She currently leads the implementation of clinical research workflows in the hospital’s new electronic medical record.
Dr. Christopher Marshallsay
A PhD biochemist, currently working as Director, Head Medical Writing and Public Disclosure at Grünenthal (Aachen, Germany). He has 20 years’ experience in various roles in clinical development (i.e., in pharmacokinetics, medical writing, clinical trial disclosure, and as department/function head) whilst located in Aachen, Frankfurt, and Paris. He has previously worked at Ciba-Geigy, Aventis, and sanofi. He is an expert in continuous improvement and an experienced lecturer/workshop leader.
Dr. Wilma Meijs
study Biochemistry, Wilma Meijs performed her Ph.D. research into
radiopharmaceuticals. Since 1996 she worked at QC and QA departments of
different pharmaceutical companies. During her carrier, she gained experience
with a wide variety of different pharmaceutical products, including small
molecules, complex parenteral dosage forms, proteins, vaccines, gene
therapeutic and cell therapeutic products. From 2003 she has been involved in
different projects aiming the set up and implement the GMP-requirements for
pharmaceutical products for clinical use. Since 2013, she also fulfilled a
QP-role for these investigational medicinal products.
- Her real passions:
- Biotech manufacturing processes/QC-testing
- Risk Based Product development
providing standardized training but also tailor-made sessions adapted to the
specific needs of the client and the company.
Languages: Dutch & English
Dr. Sonia Mesia Vela
Sonia is currently Project Delivery Lead at GSK. In this role, she is responsible for the execution and delivery of clinical development plans. Since starting at GSK in 2008, Sonia has worked in the early development portfolio until recently when she moved to life cycle management. Over her tenure in clinical operations in GSK, Sonia has broadened her strategic and operational expertise in vaccine development. Prior to joining GSK, Sonia worked for 4 years at Columbia University (Manhattan, USA) coordinating the execution of NIH funded clinical studies in the respiratory area.
Ms. Nora Meskini
Ms Meskini has over 19 years of experience in the execution and coordination of clinical trials. Prior to her position at Bone Therapeutics, she was Associate Director of the European Clinical Program at Cytori Therapeutics for three years. Earlier, she held positions as Program Director, Clinical Operations EMEA and Sr Clinical Research Manager EMEA at Biosense Webster by Johnson & Johnson.
Ms. Elina Murtomaki
Having taken her MSc and MPhil in Pharmacy and Biopharmacy at Helsinki University, Elina Murtomaki has spent over 25 years successfully leading clinical operations for pharmaceutical development. Elina has worked across all phases (I-IV) of the development process and has provided project leadership across diverse therapeutic areas. She has particular experience of outsourcing and contract management. During her time in the industry Elina has worked with both global pharma and biotech companies
For the last decade, Elina has functioned as an independent consultant for pharmaceutical and medical device development, providing leadership spanning both clinical operations and clinical science.
Elina joined the ECCRT faculty in 2017 and now provides regular training in clinical research and co-monitoring.
Mr. Peter Musschoot
Peter Musschoot has been working in different roles with both operational, expert and management teams and with leaders and leaders-of-leaders during more than 15 years. Initially working in HR services and business development, he grew into a management team member function for a HR consultancy. Later he found his true passion as a leadership trainer and coach at the Belgian Post.
Since 10 years Peter is working globally as a trainer, team & personal coach and as a large group facilitator and speaker. He has facilitated several (very large) group and individual sessions for life sciences organisations. Also, he helps teams and organisations create change in the fields of mission, strategy, roles, processes and culture. His appreciative and practical approach is characterised by a high degree of interaction and goal orientedness. Peter works together with clients in English, Dutch and French.
leadership and cooperation training
- consultancy with teams and organisations in the field of vision, mission, strategy and values
- team and individual training and coaching
- interactive key note speaking
- large group facilitation on desired change
Languages: Dutch, French & English
Ms. Jolanda Muurman
With a degree in Bioprocess engineering and in Management Jolanda Muurman works in the (bio)pharmaceutical industry since 2000. She started her career in the quality unit of one of the top 10 pharmaceutical companies. Her first steps were in the area of pharmaceutical packaging and the critical aspects of printed packaging materials. From there she moved on to parenteral and biotech product. For five years she has worked for a CMO in the field of Bulk Drug Substance manufacturing and Fill Finish of Investigational Medicinal Products. Combined with a manufacturing back ground and thorough understanding of GMP and Quality Assurance in biopharmaceutical product development, she has worked as a Qualified Person for IMP’s in the different stages 1, 2 and 3 of clinical product development. She speaks English and Dutch.
- Her real passions are GMP-trainings:
- GMP trainings
- Biotech manufacturing processes
- Risk Based Product development
But she also works in the field of:
- Training development and design
She is providing standardized training but also tailor-made sessions adapted to the specific needs of the client and the company.
Languages: Dutch & English
References: SynCo Biopartners, Pharming, Janssen Vaccines & Prevention, Biotech Training Facility
Prof. Pieter Neels
Dr. Pieter Neels is a native of Belgium where he trained as an MD (University of Antwerp, 1985) and was boarded as a general practitioner. In 1994, his interest for medical research led him to work for a pharmaceutical company.
In 1997, he joined the Belgian Ministry of Public Health as a senior evaluator of the clinical part of registration files in the fiels of cariology, nephrology, endocrinolgy (diabetes),...
In 2001 he was appointed CPMP member. In 2002 he was asked to take over all Belgian central vaccine rapporteurships. During this year he became infected by te world of vaccines and untill June2013 he was rapprteur of more than 15 vaccines. After being an observer for more than 5 years at the Vaccine Working Party, he was elected vice-chair of this CHMP Working Party for discussion on development and evaluation of registration files for vaccines untill June 2013. The Belgian agency started a spearhead policy in 2007 and Dr. Neels was appointed co-ordinator for the spearhead domain vaccines. EMA/CHMP has asked Dr. Neels has be an observer at the SAGE/WHO meetings and to attend several scientific meeting om vaccines until June 2013. WHO has asked Dr. Neels to attend many meetings on vaccine development all over tge world in order to share the EU regulatory requirements/comptenece in vaccinology.
Dr. Neels is also a member of the world wide network on vaccine promotion as he is asked to attend the ADVAC course (Foundation Mérieux) and the IABS conferences. In 2013 Dr. Neels was nominated associate Professor at the Namur University for a course in Vaccinology. In 2013 Dr. Neels stepped down from the CHMP and left the Belgian Federal Agency to start his own consultancy company "Vaccine-Advice" in order to be able to support vaccine development in a more efficacious way.
In 2014 Dr. Neels was elected board member of IABS-EU.
Ms. Nathalie Niclaus
Nathalie obtained her masters degree in
Biomedical Sciences at Ghent University in Belgium. Today she has over 10 years
of practical experience in clinical trials, first as a CRA and later as a
clinical study manager at top pharmaceutical companies such as Novartis Pharma
and AstraZeneca. Nathalie is dedicated to design and implement practical
solutions to overcome some of the hurdles in clinical research.
As co-founder of the patient recruitment
organization Akcelis, she is combining all her experience and knowledge about
clinical trials to develop innovative solutions and strategies for successful
clinical trial patient recruitment and retention.
Ms. Anya Nijenhuis
International trainer, consultant, coach and expert in the field of Communication Skills, People Management, (Intercultural) Cooperation, (Female) Leadership, Balanced Leadership, Teamwork, Mediation, Project Management, Change Management, Public Speaking, Conflict Management, Communicating with the media, Recruitment Skills, ….
She has worked with a variety of international organizations, amongst which a number of Fortune 500 companies and international organizations such as the European Union. Anya lived and worked in a variety of countries in Europe, Asia and USA.
She is fluent in Dutch (mother tongue), French, and English with a sound knowledge of German.
She has made representations on speaker and panel platforms covering a range of topics.
Economics Degree (HEAO Arnhem, The Netherlands 1983), Degree in Communication (K.U. Nijmegen, 1987) certified in DISC and Transactional Analysis and is a Certified Trainer & Coach.
The trainings are intensive, high-level and active, based on experiential learning and leading to true insight. They provide a theoretical and practical foundation to understand the topic.
Anya is a very good communicator, motivator and speaker. She relates very well to different kind of people by using Intercultural Communication, DISC and Transactional Analysis
More than fifteen years as Communication Specialist at Total (Netherlands, French West Indies, Great-Britain, France, USA and Belgium). For three years internal trainer in People Management and Culture Specialist at European Commission).
Considerable experience as Consultant, Trainer & Coach in all aspects of People Management, Project Management and (Intercultural) Communication particularly in the context of today’s corporate business.
She has made representations on speaker and panel platforms covering a wide-range of topics.
Prof. Koen Norga
Koen Norga studied philosophy and medicine at the University of Leuven (Belgium). He completed a paediatric internship and residency at Children's Hospital Boston (Boston, MA USA) and subsequently a paediatric hematology/oncology fellowship at Texas Children's Hospital (Houston, TX USA). He obtained a PhD in Molecular & Human Genetics from Baylor College of Medicine (Houston, TX USA).
In 2004 he joined the clinical peadiatric oncology staff at the University Hospitals Leuven, while furthering his research in development neurobiology. He is currently heading the Committee for Medical Ethics and he holds a faculty position in Medicine & Health Sciences at the Antwerp University (Belgium)
With a keen interest in paediatric drug development he has been a member of the Paediatric Committee (PDCO) at EMA since 2011, he is currently its vice-chair.
Mr. Ian Pattison
Global Head Learning and Knowledge Management at Boehringer Ingelheim
Mr. Lorin Pétré
Ms. Tatjana Poplazarova
Vice President, Head of Vaccines R&D Quality, Medical Governance and Bioethics at GSK.
Since joining GSK in Februari 2013, Tatjana has lead Scientific and Public Disclosure teams in charge of medical writing, record management, publications and public disclosure. She is one of the founders of the disclosure team at GSK Biologicals and has been spearheading both strategic and operational aspects related to transparency of human subject research. In 2013 she was appointed as Head of R&D Quality and Risk Management, Medical Governance and Bioethics. Tatjana holds an MSc degree in Biochemistry from the University of Zagreb, Croatia and a joint MA degree in Bioethics from the KU Leuven, Nijmeghen and Padova Universities.
Dr. Elena Prokofyeva
Elena Prokofyeva holds a research doctorate from the University of Tuebingen, Germany. She additionally holds a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden.
Dr. Prokofyeva joined the FAMHP in 2016 as a drug safety expert. Currently, she is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. She represents Belgium in a safety subgroup of the CTFG. Dr. Prokofyeva initiated and led an update of the Q&A-RSI document within the CTFG. Prior to joining FAMHP she conducted research at Inserm, Paris and worked at a pharmaceutical consulting company in London. Her clinical, research, and industry experience spans a number of topics such as drug safety, epidemiology, ophthalmology, cardiovascular and metabolic diseases, health services research, mental diseases, and addictions. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of a safety related part of clinical trial regulation on the national and European levels, as well as safeguarding the safety of trial participants in Belgium and in Europe are main objectives of her work.
Prof. Kevin Punie
Kevin Punie is a medical oncologist working as a staff member at the department of General Medical Oncology in the University Hospitals Leuven, Gasthuisberg, Belgium. His main areas of interest are breast cancer, genetic cancer syndromes and personalized medicine.
He graduated as MD in 2010 at the Catholic University of Leuven. He was fellow General Internal Medicine at University Hospitals Leuven and ZNA Jan Palfijn Antwerp, where after he finished his specialisation as medical oncologist at UZ Leuven. He is currently working on a PhD project with focus on liquid biopsies, metabolomics and miRNAs in breast cancer.
During his fellowship and is his current function as staff member, he was deeply involved in clinical cancer research through participation as a subinvestigator in multiple clinical Phase I-III trials in medical oncology, under the supervision of Prof. Dr. Patrick Schöffski. He is currently subinvestigator in > 25 recruiting disease-specific clinical trials, and the principle investigator for 5 breast cancer specific Phase II-III trials. In June 2017, he was selected for participation to the 2017 ECCO-AACR-EORTS-ESMO Workshop in Methods in Clinical Cancer Research in Zeist.
He is active member of the BSMO (Belgian Society of Medical Oncology) and ESMO (European Society of Medical Oncology), where he is also member of the Young Oncologists Committee with active participation to the organisation of the Young Oncologists track at the annual ESMO congress as well as several other educational tasks. He is also a member of the EORTC (European Organisation for Research and Treatment of Cancer) and involved in the EORTC Breast Cancer Group.
Languages: Dutch, French & English
Prof. Frank. E. Rademakers
Frank Rademakers is Chief Medical Technology and Innovation Officer at the University Hospitals Leuven, Belgium.
He was trained as a cardiologist at the University of Antwerp with a keen interest in physiology of the heart and ventricular mechanics. His research in this filed uses different imaging modalities, one of them being cardiac magnetic resonance which he introduced in Belgian cardiology. He did his PhD on this topic at Johns Hopkins, MD, USA. He moved from Antwerp to Leuven in 1998 where he joined the cardiology department for non-invasive cardiac imaging.
Ms. Katrien Reynders
Katrien Reynders (MSc., PMP PMI) has held several leadership roles in CROs and pharmaceutical companies. Today, she works as the Head of Feasibility and SMO at SGS, a mid-sized CRO that offers global clinical development services and has a strong expertise in early phase. One of the main challenges of the industry today remains effective patient access: about ~35% of delay in studies is due to patient recruitment, nearly one-fifth investigators do not enroll any patients and about one- third enroll only 5% of evaluable patients. There is a need for reliable patient recruitment approaches that works on different fronts.
During the ‘Patient Recruitment in Clinical Trials’ seminar, she will share the perspective of the CRO when dealing with patient recruitment. A successful patient recruitment strategy is an essential part of the whole trial lifecycle and starts already from the project initiation and protocol design stage. Implementing a robust feasibility assessment as early in the process and considering key stakeholders can avoid delays and increased costs during study execution.
Dr. Joanna Robaczewska
Dr. Joanna Robaczewska has built her professional experience in the areas of basic and applied sciences having worked in academic research, public services, and entrepreneurial environment across a range of disciplines, cultures, and countries. Currently, she has been working as a researcher for innovation management at Hasselt University. She holds a Ph.D. in Medical Science, an MSc in Biotechnology and a BSc in Sociology.
Dr. Robaczewska is passionate about the relationships between government, academic, industry and civil society stakeholders towards enabling innovation and rationalizing the global disease burden. In this context, she has developed and nurtured trusted relationships at the European and national level for devising advocacy strategies, formulating effective policies, building capacity and providing practical solutions. Her work also aims at increasing the positive impact of new technologies on health and well-being, and she has been advocating for affordable approaches supporting mental health in developing countries. She is a fellow of European Patients' Academy on Therapeutic Innovation.
Ms. Alison Roberts
After obtaining a degree in Pharmacology from the University of Bath, UK in 1979 Ms. Roberts joined the pharmaceutical industry as a Clinical Research Associate (CRA) with May and Baker in Dagenham, UK working on post-marketing cardiology studies. Alison went on to work on pain management studies for Ortho-Cilag, cardiology trials for Squibb and Merrell Dow in the UK before moving to Belgium in 1988, to take up a Senior CRA position in the European oncology department at Bristol-Myers, (later Bristol-Myers Squibb) Brussels.
Mr. Eric Rozet
Dr. Eric Rozet is a statistician since 2003. During his initial career at the Institute of Pharmacy of the University of Liège (Belgium) he gained experience in applied statistics for the development of assays, processes and for setting up animal testing experiments. Since the beginning of his career he has been giving statistical trainings to staff of the BioPharmaceutical industry in Europe. Since Eric joined Arlenda in 2013, he has deepened his experience and knowledge of the areas where statistics readily helps te design, analyses and understanding of trials and tests.
Eris is delighted to develop and provide training in applied statistics to transmit is passion of statisitcs and simplify in an accurate manner the understanding of this peculiar subject.
He is an author of more than 110 scientific papers and book chapters. As a trainer he is specialised in statistics applied to the biopharmaceutical industry.
His expertse are "Applied statistics in the Biopharmaceutical industry"-trainings
-Basic statistics for clinial trials
-Design od Experiments
-Statistics to prove equivalency
-Optimisation of (bio) assays and of (bio) pharmaceutical processes using Design of Experiments
-Quality by Design and Design Spaces
-Transfer of (bio)assays
He is providing classroom and virtual teaching of academics and company staff, located globally ,but also tailor-made sessions adapted to the specific needs of client and/or company
Prof. Robert Rubens
Professor Robert Rubens is doctor in Medicine, Surgery and Obstetrics. He is a professor of internal medicine at the Ghent University, Belgium where he teaches Endocrinology, History of Medicine and Medical Ethics.
Dr. Cornelia Rüdig
Dr. Cornelia Rüdig is Research Associate with supervisory responsibilities at the Department of Drug Assessment at the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). At IQWiG she is responsible for the scientific assessment of pharmaceuticals, the development of assessment methods as well as the Institute’s collaboration with external parties. Prior to joining IQWiG in 2012, Cornelia Rüdig worked in market access consulting for about 6 years with a focus on pricing & reimbursement and outcomes research. Before moving to market access she was involved in basic research in the areas of neurobiochemistry and molecular biology at the universities in Tübingen and Milan. Cornelia Rüdig holds a Diploma in Nutritional Sciences from the University of Gießen and a Dr. rer. nat. from the University of Tübingen, Germany.
Ms. Jolanda Schavemaker
Jolanda Schavemaker holds a master’s degree in Biomedical Science including a minor ‘Fundamentals of Business and Economics’ from the Utrecht University in the Netherlands. In 2006 Jolanda started working as a CRA within the pharmaceutical industry. She has been working in clinical research ever since monitoring and managing (inter)national clinical studies within a variation of therapeutic areas including Medical Foods, Oncology and Alzheimer’s disease. Since 2018, she is working as a freelancer offering all-round clinical research expertise including (global) study start-up activities, project management and SOP development. Training, coaching and personal growth have been integrated in her day-to-day activities where helping people and projects moving forward have been a key aspect throughout Jolanda’s personal life as well as professional carrier.
Mr. Sascha Seidl
Sascha Seidl started his Clinical Research career in the clinical operations group of a small CRO over 10 years ago. He currently holds the position “Associate Director Clinical Trial Transparency” at Merck KGaA, Darmstadt, Germany. Sascha currently manages Merck’s “Responsible Data Sharing” activities and developed several Merck Quality Documents and Processes for various clinical trial data disclosure deliverables. He is a member of the TransCelerate Placebo and Standard of Care initiative and participated in all EMA EU Portal User Acceptance Testings. Sascha holds a MSc degree in Biology from University of Muenster and is a certified Clinical Research Associate/Clinical Data Manager from mibeg Institut Medizin, Cologne, and a Lean & Six Sigma green belt.
Dr. Daniel Siderits
ABF Pharmaceutical Services GmbH, Vienna - Austria
Mr. Mitchell Silva
Mitchell is M-Health Coordinator at ReumaNet and CEO of
Esperity. ReumaNet is an umbrella organisation for patient organisations
in the field of rheumatology. Esperity provides digital tools to enhance
patient empowerment, to promote clinical trials and to increase patient
engagement for clinical trial participants. Mitchell got a PhD in Bio-Engineering
at the KULeuven and is passionate about health technology.
Ms. Catherine Ska
Catherine is physiotherapist as background and started immediately as drug safety assistant CRO after her studies. She has been working for CROs and pharma industries since 16 years in Clinical Research as CRA, project manager, clinical trainer and GCP compliance manager. Since 4 years, she is working as a freelancer in the pharmaceutical industry and currently providing services in GCP compliance such as SOP creation, compliance checks, audit and inspection readiness for pharma companies from start-up size to well-established companies
Ms. Nelle Stocquart
With a master’s in chemistry Nelle Stocquart works since 2003 in the Clinical Research world. She was first an IVRS project manager for a Belgian CRO but then she wished gaining more experience on the field and became CRA for a top 5 international CRO where she got involved in many international phases II & III from early study stage till closure. She then evolved as project manager in pharmaceutical companies and CRO where she managed local and international studies from phase I to phase IV. She is now working for the Belgian government which is funding academic studies.
Nelle has a lot of experience in project management, team management and people coaching. Training, Coaching, Education and Continuous Professional Development have always been the common pillars in her educational path and professional career. She speaks fluently 3 languages (Dutch, French and English).
Her real passions are “technical skills”-trainings:
- Project Management
- Risk Management
- Risk-Based Monitoring
- MS Project
- Time Management
- GCP trainings
She is providing open courses, but also tailor-made sessions adapted to the specific needs of the customer.
Dr. Marie-Anne Thil
Marie-Anne Thil obtained a PhD in Biomedical Sciences at the Catholic University of Louvain. During her PhD, she also gave some practical and lecture classes as well as led interdisciplinary seminars. She started her career in clinical research in 2007 and work now as medical writer at Keyrus BioPharma. She has a strong experience in developing regulatory documents, from protocol to study report, for national and international Phase I to IV studies. She also developed numerous documents for non-interventional studies and was involved results dissemination (articles, poster, …).
Marie-Anne enjoys sharing her knowledge with peers and, as senior medical writing, she is also in charge of training the junior medical writer and new comers within her company.
Dr. Nathalie Thomas
is a Senior Consultant in the CNS UK office. Natalie holds a PhD in
biochemistry and molecular biology and started her career as a Research
Scientist in the Australian pharmaceutical industry, prior to moving to the UK
to commence work in regulatory affairs and product development. Natalie worked
in consultancy and project management roles at ERA Consulting and Voisin
Consulting prior to joining CNS, where she now provides EU, US and Australian
regulatory support to clients. She currently sits on the Editorial Board of the
regulatory professional journal, Regulatory Rapporteur, and has obtained the
Regulatory Affairs Certification (EU) from the Regulatory Affairs Professional
Mr. Steven Thys
Steven (41) is a seasoned Clinical Research professional with a PASSION for innovative drug research.
He graduated as pharmacist at the KU leuven and holds a master in medical & pharmaceutical research at the vub. after a short career in preclinical development, he oriented his career towards clinical drug development.
In 2002 he started at servier R&D benelux where he held various positions in clinical operations and worked in cardiology, oncology and reumatology. from 2010 onwards Steven has been leading clinOPS teams in south east asia and in western europe. today he is director global study management at servier’s headquarter in paris, overseeing trials worldwide and managing teams in 6 countries.
In 2014 steven was appointed as global pilot for developing and implementing a risk based approach for servier. Today rbm has been successfully implemented and has become the new standard within servier r&d for managing and monitoring clinical studies.
In his free time he is playing soccer, biking and playing guitar.
Mr. Hans Tielemans
20 years experience in clinical research in both the pharma and medical device industry as a Study co-ordinator, CRA, Global / European project manager; manager clinical research (including line-management) and manager Medical Affairs .
5 years experience in training and training management for pharma, biotech en medical devices companies.
Specialties and goals
• Project management of clinical studies
• Training management
• People management
Mr. François Torche
François holds a Master in Business Administration from the ICHEC School of Management, Brussels, Belgium. Over the past 20 years in the pharmaceutical industry, he has held positions as statistical programmer, SAS and JAVA developer and IT project leader for companies such as GSK, UCB and IDDI. During his ten year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the SMART™ engine, a patented software solution and the underpinning of CluePoints. Francois has served as CluePoints’ Chief Executive Officer since the company’s inception in 2012
Ms. Susan Trainor
Susan Trainor has worked and lived for over 30 years in a global environment. She has extensive international experience, including more than 25 years in bio-pharmaceutical development. She is a trained ISO-9000 Lead Auditor and a Certified empowerment and executive coach. She is consulted by the International Health Care Industry in the area of quality management, risk assessments, due diligence and leadership coaching, internationally. She has presented at conferences and congresses worldwide. She was a faculty member of EUDIPHARM, University of Lyon, for their post graduate program in pharmacology and pharmaceutical medicine from 2001 to 2004 and for the European diploma of pharmaceutical medicine for PHARMED University of Brussels, from 2005 to 2010. She was a Board Member of the EFGCP (European Forum for Good Clinical Practice) from 1995 to 2012 and was the chairperson of the EFGCP Audit Working Party from 1998 to 2002. She is the founder, President and CEO of Trainor & Partners, a firm specializing in quality management of clinical research for developed and emerging regions and she is the co-founder and Director of Sutra Quality
Management. The firms operate out of Belgium & India, with consultants situated internationally.
More recently she founded SuTra Coaching a division of Trainor & Partners specialized in Organizational Culture and Empowerment and Self Leadership coaching.
Dr. Richard Turner
BioDesk's Principal Consultant in the UK office, has been working in
biopharmaceutical development for over 20 years. Richard is a former
Pharmaceutical and Scientific Assessor at the Medicines Control Agency (now
known as the UK MHRA) and has worked in senior regulatory positions in a number
of biopharmaceutical development companies and consultancies including Daiichi
Sankyo, Lonza Biologics, ERA Consulting, Elan and Antisoma.
Mr. Marc Van Autreve
Following studies in Press
and Communication Marc Van Autreve worked for the VRT as a radio producer,
programme director, announcer and presenter for a number of years. After this
successful experience he moved into the international world of training as a
coach, trainer and consultant.
As a visiting lecturer for the likes of UAMS, Eshal-Instima and KHLeuven he gave sessions on subjects such as strategic sales management and communication.
Passionate about values such as individuality, autonomy, empathy, respect and inspiring leadership, Marc used a dynamic manner, through coaching and training, to develop management skills to enable the manager and his staff to generate improved results.
Prof. Pierre Van Damme
Pierre Van Damme, MD, PhD
is one of the foremost researchers in the epidemiology and prevention of
infectious diseases and has been involved as the principal investigator in more
than 100 vaccine trials. In 1994, he set up the Centre for the Evaluation of
Vaccination at the University of Antwerp, which has since been designated a WHO Collaborating Centre for Prevention and Control of Viral Hepatitis. Among his other research interests are the conduct of vaccine trials and cost-effectiveness analysis of preventative strategies in infectious disease management. Professor van Damme has authored more than 170 peer-reviewed articles and is on the Editorial Boards of several scientific journals that focus on the study of vaccines and vaccine-preventable infectious diseases.
Ms. Kristel Van de Voorde
Kristel Van de Voorde is the global head of the internal audit group for clinical trial and safety related audits since 2014. She joined the Global Quality Regulatory Compliance Department of Bristol-Myers Squibb on 1 June 1993 as Regulatory Compliance Auditor. In 2004, she was appointed Director Europe to become more involved in the organization and planning of clinical trial and safety related audits. Kristel has set up a risk based audit approach and has led many health authority inspections.
Prior to joining BMS, Kristel worked as Clinical Research Associate with Servier Benelux, where she attained the position of Project Leader Therapeutic Research. She became responsible for Data Management and Quality Assurance.
Kristel qualified as a pharmacist at the Free University in Brussels and earned degrees in Applied Statistics in medicine (CESAM, Paris), in Medical and Pharmaceutical Research (Free University Brussels). She obtained a post-graduate degree in Business Administration – options Management and Marketing (VLEKHO, Brussels).
Kristel is also registered as lead ISO 9001 assessor and is part of the faculty of the DIA GCP Compliance course since 1995 and became the course director in 2014.
She is a passionate, dedicated and knowledgeable leader who can get things done, generate new ideas and motivates others because she pursues excellence to create the best quality organization that makes a difference.
In her spare time, Kristel likes to paint and visit art exhibitions
Ms. Nele Van den Cruyce
Nele Van den Cruyce has an academic background within the sociology of health (PhD in social sciences). She currently is the manager of the social department in the Belgian Foundation against Cancer. This department organizes practical services to patients (i.e. financial aid, physical exercise program, etc.); invests in psychosocial projects which are organized by other stakeholders on the field; finances and executes psychosocial research. Patient advocacy and health literacy are primordial topics within the department.
Dr. Caroline Van Droogenbroeck
Caroline Van Droogenbroeck obtained her degree in Bio-engineer Sciences – Cell- and gene biotechnology from the University of Gent, Belgium in 2005. After obtaining her PhD in the Department of Molecular Biotechnology at the University of Gent, Belgium in 2010, she started working as a biosafety file manager at the Department of Biosafety and Biotechnology (SBB) at the Scientific Institute of Public Health (WIV-ISP).
From 2011 on, she is working at the Federal Agency for Medicines and Health Products (FAMHP), where she gained experience in the regulatory field of clinical trials and the assessment of non-clinical data. Currently she is the coordinator of the safety subdivision within the Clinical Trials R&D department of the FAMHP.
Sciences, University Ghent.
Prof. Viviane Van Hoof
Viviane Van Hoof (MD, PhD, University of Antwerp, Belgium)
is a clinical pathologist and head of the department of Clinical Chemistry of
the Antwerp University Hospital.
She is a Professor of Clinical Biochemistry at the Antwerp University.
Presently, her main interests are Point-of Care testing, laboratory informatics
(expert systems), cardiac markers, markers of bone metabolism and
bilirubin. She performs reviews for national and international scientific
journals, published more than 50 articles in peer-reviewed journals and
was invited speaker in more than 60 national and international scientific
meetings. She is a member of several professional organizations and of
several committees and working groups of the Belgian Government of Health.
Prof. Benedikt Van Nieuwenhove
Prof. Dr. Benedikt Van Nieuwenhove obtained his degree in Pharmaceutical sciences from the University of Gent, Belgium in 1991. Between 1991 and 1997 he worked as a quality assurance manager at a laboratory for medical biochemistry & clinical analysis in Gent. In 1997 he finished his Ph.D. in Pharmaceutical Sciences at the University of Gent in Belgium.
Since then till 2014 he had been working for Harrison Clinical Research. He started his career as clinical operations manager and general manager of the Benelux operations.
In 2000, he founded their own training Academy, the "European Centre for Clinical Research Training” (ECCRT) and in 2007 he became a member of the Board.
From 2008-2011 he acted as the Vice President Global Operations of the Harrison Clinical Research group. In January 2011, he was elected Chief Executive Officer of Harrison Clinical Research. In that position he was involved in the merge with Synteract to form SynteractHCR. He has been instrumental in integrating the two organisations during 2013 and 2014.
Since its creation in 2000, Benedikt has been the Managing Director of ECCRT.
Having been in the field of Clinical Research for about three decades he has amassed a wealth of knowledge and skills within this field. Over the years he has supported the Pharma Industry as well as other players in the healthcare sector by providing them with the skill sets to deal with the challenges in their job and to make them efficient players in study success.
Since 2016 he is lecturing “Management of Clinical Research” at the Faculty of Pharmaceutical Sciences, University Ghent.
Mr. Olivier Van Obberghen
Olivier Van Obberghen is partner at Quinz, an innovative law firm that focuses on advising and assisting (bio-) pharmaceutical, biotech and medical devices companies on transactional, regulatory and intellectual property matters throughout the different stages of the life cycle of drug products and medical devices. Olivier’s expertise mainly focuses on transactional and regulatory questions relating to R&D, clinical development and supply chain.
In the clinical development stage, Olivier negotiates various types of clinical trial agreements with the different actors involved in a clinical trial (sponsors, CRO’s, investigators/hospitals, central labs, freight services providers, data analysts), and assists on legal issues faced when drafting clinical trial protocols and informed consent forms. He also advises on regulatory and other compliance issues (such as GCP, clinical trial applications, payment of fair value, insurance, data privacy).
Olivier was seconded for more than 2 years to the legal department of UCB, and studied law at the Catholic University of Leuven (KU Leuven) and the University of Chicago Law School. He is licensed to practice at the Brussels Bar.
Ms. Dominique Van Ophem
Dominique Van Ophem has a nursing, management, quality and audit background training. She is working in clinical research at the Cliniques universitaires Saint-Luc (CUSL) for 21 years now. Her field experience in clinical research started as a trial nurse in oncology then was pursued as coordinator of international academic trials in transplantation.
At present, she is responsible at institutional level (CTC)for the regulatory affairs (since 10 years) and quality management (since 4 years).
She managed the AAHRPP accreditation process for the CUSL from 2012 to 2015 which was the first European hospital to receive a full international recognition for the quality its clinical research activities.
Today, her quality management activities are focused on the development of our QMS, training and auditing
Dr. Jean Van Rampelbergh
Jean Van Rampelbergh is Doctor in Biomedical Sciences from the Université Libre de Bruxelles.
After a post-doctorate in Paris, he started a second one in 2000 in the pharma industry for Janssen Pharmaceutica Foundation, collaborating to early pre-clinical activities.
As of 2002, he shifted his activities towards the clinical part of the development. He started as a CRA for Organon and then moved to Sanofi-aventis in 2005 to successively embrace the functions of Project Leader, Clinical Operations Manager Head of the Clinical Study Unit of Sanofi in Belgium. During his last 2 years at Sanofi he was one of the five global responsible leaders for reshaping the clinical development pathway.
In 2013, he created his own consultancy company directed towards supporting spin-off and start-up companies for their clinical development needs at early stages. He recently successfully moved the biotech Imcyse into clinical stage in type 1 diabetes with excellent results in phase 1.
Next to this, Jean is eager to share his knowledge through training sessions for different audiences.
Dr. Marleen Verbeeck
Marleen Verbeeck, is a trainer/coach and has been working at the European Centre for Clinical Research Training (ECCRT) since 2004.
She obtained her PhD in molecular biology at the University of Utrecht in 1990. After fundamental research positions at the universities of Utrecht, New York, Leuven and Maastricht, she changed her academic career in 1995. She gained solid grounding in clinical research, first as a clinical research associate, later as a medical writer combined with a position as trainer.
Marleen enjoys developing, lecturing, evaluating and developing comprehension tests of courses as well as boosting confidence and competence of clinical research professionals with different experience levels from the pharmaceutical, medical device industry and non-profit research organisations.
She has more than 15 years of educational expertise. She is author of scientific papers, clinical trial study protocols (phase I - IV) and clinical study reports. She has experience in medical areas such as : CNS, Gastroenterology, Gynaecology, Rheumathology, Cardiology, Oncology, Orthopaedics and Immonutherapy.
In addition, recently Marleen is also a regulatory consultant on European clinical trial legislation. Acquiring and conveying knowledge has always been her interest throughout her professional career.
Mr. Kristof Vercruysse
Kristof has spent the last 20 years working in Pharmaceutical, Biotechnology and CRO Industry with strong focus on Operational and Project Execution from Proof of Concept in Animals to Proof of Concept in Humans. After finalising his studies at the Free University of Brussels, his career brought him from UNDA, PRA International to Organon and Nycomed where he was responsible for clinical trial management of international interdisciplinary clinical trials. At Ablynx (Biotech), Kristof held the position of Director Clinical Operations, being responsible for seamless translation of early development into the Clinic. In 2015, Kristof Joined Sourcia, a boutique CRO focussing on small to medium size enterprises, as Director Project Management and Early Development supporting several Biotech companies in progressing their compound from Proof or Concept in Animals into the Clinic and beyond. This experience provided deep insights in seamless parallel development of Pre-Clinical, Chemical Manufacturing and Controls and Clinical Development, in Small Molecules, biologicals and cell therapy in a variety of clinical indications.
Mr. Bert Verheyen
Bert Verheyen (BSN, RN, Ghent) started his professional career in Intensive Care and Coronary Care units (UCL-10 years). After that, he changed for the Pharmaceutical sector (13 years), working successively as sales rep (Astra), Product Manager (Astra, Beecham) and Marketing Manager (Bayer). Finally he moved to Clinical Research Center of a major device company (Medtronic-17 years) where he was managing Clinical Operations and Monitoring.
Among his main tasks in this latter position, he had to hire, train and coach a group of 12 CRAs. With this group he was co-ordinating monitoring activities for 15+ studies running simultaneously in 20+ countries (Europe, Middle East, Africa, Far East). Among his activities featured also providing training on SOPs, GCP, ISO 14155 and monitoring techniques. Bert Verheyen holds a 10 year uninterrupted certification as CRA (CCRA) with the worldwide professional organization ACRP for which he also presented several times on monitoring topics at their world congresses.
Prof. Joris Vermeesch
2016: Chair Department of Human Genetics, KU Leuven
2013: Full Professor, Department of Human Genetics, KU Leuven
2009: Part time full Professor, Department of Human Genetics KU Leuven
2008: Coordinator Genomics Core, UZ-KU Leuven
2007-2009: Associate Professor, Department of Human Genetics, KU Leuven
2004-2007: Assistant Professor, Department of Human Genetics, KU Leuven
2001: Director Cytogenetics unit, Center of Human Genetics, UZ Leuven
1999-2001: Groupleader genomics in Aventis CropScience, Ghent, Belgium
1993-1999: Postdoctoral fellow, KU Leuven
1988-1993: Ph.D in Chemistry, Nebraska, USA
1988: Ir. Bioengineer University of Gent, Belgium
Ms. An Vijverman
An Vijverman is a partner with the law firm Dewallens & partners, a specialized law firm operating exclusively in health law. Within health law An specialises in privacy legislation (data protection which nowadays obviously mainly includes legal assistance on GDPR-compliance), eHealth, RIZIV/INAMI procedures (national sickness and invalidity insurance institute), pharmaceutical law, medical devices, medical apps and life sciences. The assistance of pharmaceutical companies and companies active in biotechnology, medical devices, pharmaceutical research (CRO's), medtech and healthcare ICT is at the core of her practice.
Through her dedication Dewallens & partners became the Belgian member of the Alliance of European Life Sciences Law Firms in 2015.
An has authored a wide variety of publications on various aspects of health law. In 2013 she published her book called “Het elektronisch medisch dossier. Praktische en juridische knelpunten” (The electronic medical file. Practical and legal issues). Each year she also publishes the “Chapter for Belgium in “Getting the Deal Through – Life Sciences” and she has co-authored the book "Chapters on Pharmaceutical Law". She has also written the chapters “Experiments on the human being”, “Medicinal products” and “Medical devices” in the Belgian Manual on Health Law (2014).
An also regularly lectures on issues of healthcare law. She teaches various courses of health law (mainly focused on privacy law) at Ehsal Management School, Brussels and at the Antwerp Health Law and Ethics Chair (AHLEC) at the UAntwerpen and as a trainer she is attached to the European Centre for Clinical Research Training.
She is a member of the National Commission on the evaluation of the legislation concerning the interruption of pregnancy, of the editorial committee of the 'Tijdschrift voor Gezondheidsrecht/Revue de Droit de la Santé' (Journal for Health Law).Belgian Journal of Health law, of the Brussels Pharma Law Group and of the legal working group “e-health” at the FOD/SPF Public Health.
One of her real passions is advising companies in clinical trial aspects such as:
Data Protection in Clinical Trials
Liability & Insurance in Clinical Trials
But she also works in the field of:
Health law in general
She is providing standardized training but also tailor-made sessions adapted to the specific needs of the client and the company.
Languages: Dutch, French & English
Dr. Bernard Vrijens
Bernard Vrijens is Chief Executive Officer at Advanced Analytical Research on Drug Exposure (AARDEX Group). He is also Invited Professor of Biostatistics at Liège University, Belgium.
Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics from Ghent University, Belgium.
Dr Vrijen’s currently leads a research programme investigating (a) the most common errors in dosing using a simple but robust taxonomy, (b) particular dosing errors that can jeopardise the efficacy of a drug, and (c) the optimal measurement-guided medication management programme that can enhance adherence to medications and maintain long-term persistence.
Dr. Vrijens is a co-author of seven book chapters, over 100 peer-reviewed scientific papers, and named as inventor on 6 patents. He is a founding member of the European Society for Patient Adherence, Compliance, and Persistence (ESPACOMP), and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications.
Dr. Vrijens is a highly-accomplished public speaker, having presented lectures at over 200 industry events and scientific conferences around the world over the past 20 years. Public speaking experience includes the NIH Adherence Network Distinguished Speaker Webinar Series, CDER Drug Packaging Summit at FDA, European Society of Cardiology Congress, American Society on Pharmacometrics, WHO Global Forum on Innovation for Aging Populations, among many others.
Mr. Thomas Wicks
Thomas is responsible for the strategy of TrialScope’s clinical trial disclosure and transparency solutions. He has more than 19 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labelling and submissions management. Thomas has been a been on focused on trial transparency since 2007.
Ms. Meryl Wiernik
Meryl is the Senior Director of Vendor Management at ProSciento, an early phase CRO specializing in the metabolism therapeutic area; in an earlier role, she was the Senior Director of CRO Services at ProSciento, responsible for building the CRO division of this early phase clinic and for as the development and execution of key strategies supporting growth and continued development of CRO operations. Meryl was previously a consultant to the biopharma industry in the areas of Quality Assurance, vendor management, outsourcing, and business process optimization. Meryl has served as the VP of Quality Assurance and Business Excellence for Synteract, a mid-sized global CRO, where she led the global QA group, participated in company integration activities after an acquisition, global harmonization, and enhancement of quality processes. In earlier roles, Meryl was the Director of Strategic Outsourcing for Teva Pharmaceuticals, Bristol Myers Squibb and Amgen; for Teva and BMS, she originated these departments, and built standardized outsourcing processes as well as a structure for vendor governance. Meryl has worked for several central laboratories, including LabCorp, MDS Pharma, Quest Diagnostics and ACM, in functions including Project Management, Operations, Quality, client relationship management, global harmonization, and Biorepository management. During her 19 yr tenure at Bristol‑Myers Squibb, she was instrumental in the conceptualization, implementation, growth, and marketing of the BMS Clinical Laboratory, in support of the phase I unit as well as Phase II-IV trials.
Meryl holds a BS in Medical Technology from Rutgers University and an MBA from Fairleigh Dickinson University.
Mr. Bartelt Wils
Bartelt has over 20 years’ experience in providing training services. After graduating with a degree in Industrial Engineering and Social Pedagogy, he followed a course of study in MBTI accreditation, leading groups based on gestalt and systems thinking, and working as a counsellor based on a Rogerian approach and breakthrough consultancy.
He specialises in applied knowledge in the areas of communication skills, personality models, consultation strategies and self-management.
More specifically, his service focuses on:
- Canvassing and sales
- Customer-oriented working
- Presentation skills
- Telephone techniques
- Train the trainer
- Win-win strategies
Languages: Dutch & English
Mr. Pieter Wyckmans
Pieter is a lawyer and partner at the law firm Quinz. Pieter specializes in providing expert advice to Life Sciences companies in R&D, transactional, regulatory and intellectual property matters, and strategic licensing projects. Pieter combines years of experience as an M&A and commercial transactions lawyer, with years of experience as in-house counsel of multinationals, particularly in the Life Sciences industry. His experience as in-house counsel made Pieter Wyckmans accustomed with the (bio)pharmaceutical environment and conscious of the scientific, economic and regulatory challenges the industry faces.
Pieter started his career at the corporate M&A department of Linklaters and Loyens&Loeff. Later he joined the legal department of BASF and GDF Suez as senior counsel and offered his services as independent legal consultant to UCB. In 2000 he graduated from the Catholic University of Leuven. In 2003 he obtained a 'D.E.A' "Droit des Contrats d'Affaires" at the University of Montpellier, France.