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Dr. Els Adriaens 

Bio

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 

Bio

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. Brendan Barnes 

Bio

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 

Bio

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 

Bio

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. 

Dr. Hugues Bogaerts 

Bio

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 

Bio

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 

Bio

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 CHMP.
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 Nutrition Council.
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 

Bio

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 

Bio

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.

Mr. Eric Chleide 

Bio

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 

Bio

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
customers.

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
applications.

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 

Bio

Nancy is the founder and Managing Director of Ad Hoc Clinical, a small CRO based in Belgium.

Before creating her own company, Nancy gained extensive Clinical Operations expertise across various therapeutic areas. Expertise she build since 1996 both within the pharmaceutical industry as in the CRO world.
Nancy is a Clinical Research Expert, holds a Master’s degree in Strategy and Organization, and is a trained Data Privacy Officer.
Next to the day to day activities she has as Managing Director of  Ad Hoc Clinical, Nancy acts as an expert in European Regulatory /Clinical Affairs and provides training on these topics to clients / universities and her own team.
She speaks fluently 4 languages (Dutch, French, English and Spanish). 
Her real passions are coaching new and very experienced clinical trial experts to the path of excellence  via tailor made training modules: 
  • 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
But she also works in the field of: 
  • SOP making
  • Auditing
She is providing tailor-made sessions adapted to the specific needs of the client and the company.
Languages: French , Dutch , English, Spanish
References: Ablynx, ILIS ( University Lille 2 France), Parexel, …

Mr. Wim De Meester 

Bio

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 

Bio

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 

Bio

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 

Bio

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.

Mr. Marc Devisch 

Bio

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 

Bio

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 

Bio

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 GSK as medical writer since 2003. In
2007, she started as a freelance medical writer. She is author of several peer reviewed publications, clinical study protocols and reports in the field of vaccines, cardiovascular research, and oncology.

Dr. Erik Doevendans 

Bio

Dr Erik Doevendans, Owner and Consultant of BD-Consultancy B.V., is a Principal Consultant to CNS. Erik has 20 years’ industry experience with expertise in CMC and a background in quality assurance, control, medicinal assessment, regulatory affairs and manufacturing operations. Notably Erik was previously a pharmaceutical assessor at the Dutch regulatory authorities and an expert to the EMA.

Dr. Carl  Emerson 

Bio

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 

Bio

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).

Mr. Jean Fernandez 

Bio

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 

Bio

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 

Bio

Barbara Gastl has been working in clinical operations for 12 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 is her current main client, whom she is supporting in setting up their Quality Management System and running their pivotal clinical trial.


Training and compliance are her new adventures that she feels very excited about. In her spare time she roams the fields and mountains of the world on a historical or photographical mission.

  

 

  

Dr. Essam Ghanem 

Bio

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 head of Drug Safety and Pharmacovigilance at Keyrus Biopharma (BE, FR, CA, LEB)(*). Membership owner of European society of CRO Federation (EUCROF).

Dr. Dirk Gillé 

Bio

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 organization.
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  

Bio

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.

Ms. Sylvie Hermans 

Bio

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 

Bio

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 

Bio

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),...

-Strategic Advise

 

Dr. Leo Huybrechts 

Bio

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 

Bio

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 

Bio

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 

Bio

 

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
the FAMHP.

 

Ms. Angelika Joos 

Bio

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 

Bio

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 

Bio

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 

Bio

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 

Bio

Ann 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.

Ann 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. Liesbeth Lemmens 

Bio

Liesbeth Lemmens holds a Bachelor's Degree in Nursing and obtained a Master 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 - beside her work as clinical trial coordinator and project manager - to work as an independent consultant for health care providers.

Ms. Lemmens is also key opinion leader in educating health care providers, clinical research associates, clinical trial assistants and (data) managers on the latest 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.

 

Languages: Dutch, French & English

 

time management and communications.

Ms. Anne Lenaers 

Bio

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 

Bio

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
health psychology.

 

 

Dr. Kim Luyckx 

Bio

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 

Bio

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. Sonia  Mesia Vela 

Bio

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.

Sonia graduated from the Universidad Nacional de San Marcos (Peru) as Pharmacist, obtained a PhD in Sciences at the Universidade Federal de Sao Paulo (Brazil) and trained in Toxicology as a post-doctoral fellow at Rutgers, The State University of New Jersey (USA). She has authored many peer reviewed publications in the field of non-clinical and clinical research including respiratory, gastroenterology, inflammation and breast cancer as well as metabolism. Sonia also serves as reviewer of grant applications for CONCYTEC, the Peruvian branch that funds projects in Science and Technology. 

Ms. Nora Meskini 

Bio

 

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.

Mr. Peter Musschoot 

Bio

Peter Musschoot has been working in different roles with both operational, expert management teams and with leaders of all levels during more than 15 years. Initially working in business development in HR services, 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 almost 10 years Peter is working globally as a trainer, team & personal coach and as a large group facilitator and speaker. He has facilitated several group and individual sessions for life sciences organisations.
His positive and practical approach is characterised by a high degree of interaction and goal orientedness. Peter works together with clients in English, Dutch and French.

His expertise:

- 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

 

References:

DHL, Ghent University, NBC Universal, Child Focus, Teach for Belgium.

 

Ms. Jolanda Muurman 

Bio

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
  • Validation

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 

Bio

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 

Bio

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  

Bio

With a licence in Economics
/ Trade sciences and a degree in Communication Anya Nijenhuis works since 2000
as coach (certified at Gestion de Coaching) and as trainer in different fields.
She works a lot with Transactional Analysis. She has an enormous experience in
multicultural communication as she worked a lot abroad (Europe, United States, Africa and Asia),
especially in HR –related subjects.

She has made representations on speaker and platforms covering a rangd of topics. 

Her trainings are intensive, high-leven and active, based on experiential learning and leading to true insight. They providg 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

 

Prof. Koen  Norga 

Bio

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.

Ms. Tatjana Poplazarova 

Bio

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.

Mr. Andy Powrey-Smith 

Bio

TBC

Dr. Elena Prokofyeva 

Bio

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.   

Dr. Kevin Punie 

Bio

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

Ms. Katrien Reynders 

Bio

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.  

  

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Dr. Joanna Robaczewska 

Bio

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 

Bio

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.

In 1991, Alison joined Roche in Strasbourg, France as an International Clinical Auditor, where, in addition to conducting audits, she had responsibilities for liaison between clinical research personnel and the QA group and for the training of new auditors. Alison moved to Quintiles’ European Quality Assurance Services and Consultancy Business Unit in Strasbourg, France in September 1997 and in June 1999 became Executive Director, heading-up a team of 12 auditors across Europe. She left Quintiles in July 2001, to start her own audit and consulting company, Qualitus.
Alison was a member of the tutorial panel on the DIA course "Practical GCP Compliance Auditing of Trials and Systems" from 1997 to 2006 and was an invited lecturer on Clinical Quality Assurance at the Université Louis Pasteur in Strasbourg as part of the DESS in Quality / Master's course in Quality and Organization from 1993 until 2009. She taught the GCP module of the TOPRA Masters Course in the UK in 2008 and 2010. She has been a member of BARQA (now RQA) since 1995 and joined the EFGCP Audit Working Party in 2012.

Mr. Eric Rozet 

Bio

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

-Linear Models

-Design od Experiments

-Bayesian Statistics

-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 

Bio

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. Daniel Siderits 

Bio

ABF Pharmaceutical Services GmbH, Vienna - Austria

Mr. Mitchell Silva 

Bio

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 

Bio

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

  

Mr. Aize Smink 

Bio

With nearly 25 years of experience in various global CROs and having worked with clients from all regions of the world, Aize Smink leads Chiltern's CRO business. Aize joined Chiltern in 2006 from Charles River Laboratories where he was Vice President, Global Project Management. At Chiltern, Aize has responsibility for the strategic leadership in the delivery of clinical, biometrics and scientific services accross all phases and indications. Aize was born in The Netherlands and graduated in Biochemistry, MSc, from the State University Groningen. He is based in Brussels, Belgium.

Ms. Nelle Stocquart 

Bio

Nelle obtained a master in Chemistry in 1997 at ULB. She then worked in variety of companies and institutions as researcher until 2002.

Her first experience in clinical trials was in 2003 when she became an IVRS project manager at S-Clinica, a Belgian CRO. Her wish was finally to be on the field and she became CRA at PAREXEL where she got involved in may international phases II & II 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.

Nelle has experience in managing international phase I, II and III studies in oncology but also rare diseases, cardiology and immunology. Training, coaching, education and continuous professional development have always been the common pillars in her educational path and professional career.

Ms. Selene Tedeschi 

Dr. Nathalie Thomas 

Bio

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
Society (RAPS).

 

Mr. Steven Thys 

Bio

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 

Bio

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 

Bio

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

Dr. Richard Turner 

Bio

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 

Bio

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.

Dr. Annie Van Broekhoven 

Bio

CEO at amatsiQBiologicals

Prof. Pierre  Van Damme 

Bio

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 

Bio

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 

Bio

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 

Bio

 

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 

Bio

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 

Bio

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 

Bio

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 

Bio

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. Marleen Verbeeck 

Bio

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.

Courses

Mr. Bert  Verheyen  

Bio

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.

Ms. An  Vijverman  

Bio

An Vijverman is a partner with the law firm Dewallens & partners, a specialized law firm operating exclusively in healthcare.Within medical law An specialises  in privacy legislation (data protection), eHealth, RIZIV/INAMI procedures (national sickness and invalidity insurance institute), pharmaceutical law, medical application and life sciences. The assistance of pharmaceutical companies and companies active in biotechnology, pharmaceutical research (CRO's) and healthcare ICT is at the core of her practice.

 

Through her dedicaion Dewallens & partners became the Belgian ember of the alliance of European Life Sciences Law firms in 2015.

An has authored a wide variety of publications on various aspect of health caare law. In 2013 she published her book called "Het elektronisch medisch dossier". Praktische en juridische knelpunten. (The electronical file. Practical and legal issues). Each year she is also publishing the "chapter for Begium in "Getting the Deal through - life sciences" and she has co-authored the book "Chapters on Pharmaceutical Law". An regularly lectures on issues of healthcare law, she teached health law at Ehsal Management School and at Ahlec, the Antwerp Health Law and Ethics Chair 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 and of the editorial committee of the 'Tijdschrift voor Gezondheidsrecht' (Journall for Health Law).

 

 

Mr. Bartelt Wils 

Bio

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:

-                 Assertiveness

-                 Canvassing and sales

-                 Customer-oriented working

-                 Leadership

-                 MBTI

-                 Presentation skills

-                 Telephone techniques

-                 Train the trainer

-                 Win-win strategies

 

Languages: Dutch & English

 

  

Mr. Pieter Wyckmans 

Bio

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.