Trainers

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.

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 Stephen Bentley is currently Chairman of Verius Limited, a member of the Product Life Group and a specialist provider of pharmacovigilance, clinical safety and regulatory services to the pharmaceutical and medical device industries. 

In over 30 years in the pharmaceutical industry, Dr Bentley has held a variety of posts in research, development and medical services in Europe and spent six years  in Japan as a Research and Development Director.  He set up Verius Limited in 2005.

Dr Bentley is a graduate in medicine from the University of Manchester and is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK.

Donna Berk, MS, obtained her undergraduate degree at the University of Pennsylvania and her Masters in Applied Anatomy and Physiology at Boston University.  She is the Director of Harrison Clinical Research US operations. She has worked in the pharmaceutical and device industry for 20 years working for both pharmaceutical and CRO companies.  She has strong operational expertise and developed and lead training programs and has worked in
a variety of therapeutic areas Phase I through IV. She is a member of ACRP and DIA and was elected  by PharmaVoice (2005) one of the most inspiring research professionals.

Result-oriented, Didier Blésin is a passionate trainer and consultant specialised in communication, sales, customer loyalty, and personal development. After 20 years managing and leading trade and services companies in Europe, he helps other professionals acquire the best practices and tools to be successful. He is convinced that immediate action with measurable results must follow creative ideas and trainings.

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.

Mr Bonnarens

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. 

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.

A graduate in Pharmacology and Chemistry from Sheffield University, Carl spent most of his working life at the same company. Starting as a bench chemist for Glaxo, a succession of varied posts in the medical area followed as the company merged and grew.  Having also worked in small biotech, his latest position was to lead the clinical procurement process for GSK’s vaccine business out of Belgium.  He has now amassed over 17 years experience in clinical outsourcing and, while studying his executive MBA at Vlerick Business School, has taken time to co-found Emerson Consulting bvba in Belgium. This company is now being used to offer to others the benefits of his years in: resourcing strategy development, negotiation, training and process development to relevant companies in the pharmaceutical sector across the world.

After a Masters degree in translation and interpretation, Vincent Geeraerd had an eclectic career which drove him successively through the development of a translation bureau and has the direction of two advertising agencies before being marketing & communications manager North Europe for the motorcycle brand Ducati. Back in Belgium, he led a project of Business Process Management during 5 years, in conjunction with his passion: training. Today, the choice is made and as a partner of Le Soleil Training & Consult, he provides trainings related to "soft skills" in the broadest sense of the concept.

Dr Marisa Giro has a sound experience in clinical research area from 1986 co-ordinating activities aimed to monitor national and international clinical studies, assuring compliance with GCP, SOPs and protocols, respecting enrolment time and supporting   and training investigators involved in clinical studies.  Dr Giro is also teaching communication techniques by Agenzia Formazione Lavoro and speaker in the courses of Q.A. Partner’s as : “Relationships between pharmaceutical industry and clinical sites and on drug handling and supplying.”

Sylvie Hermans completed her Master Industrial Science in 1990 and and finalized her Education in Pedagogic Competence in 1994. She started working in the pharmaceutical industry as a Medical Deleguee in 1990, she switched to clinical research in 1996. Her job experience ranges from CRA over Lead CRA to Clinical Project Manager in CROs, pharmaceutical, biotech end medical device companies.

The clinical trials she monitored and managed were international phase I to IV studies as well as observational studies, in a wide range of therapeutic areas.

Jay Herson received his Ph.D. in Biostatistics from Johns Hopkins in 1971. After working on cancer clinical trials at MD Anderson Hospital he formed Applied Logic Associates (ALA) in Houston in 1983. ALA grew to be a biostatistical-data management CRO with 50 employees when it was sold to Westat in 2001. Jay joined the Adjunct Faculty in Biostatistics at Johns Hopkins in 2004. His interests are interim analysis in clinical trials, data monitoring committees, and statistical / regulatory issues.

Rafaël Hoebrechts was born in Belgium in 1960. He completed his studies in Nursing in 1981 and started work in the ICU and emergency ward of a major Antwerp hospital, where he remained for 10 years.
For the last 18 years, he has held positions in the pharmaceutical and medical device industries (Sanofi/Aventis, Smith & Nephew, Bristol-Myers Squibb, Knoll/BASF) and in CROs (PPD, Msource and latterly IATEC).
His job experience ranges from clinical research operations and project management to business acquisitions and international business development. He has extensive line management experience and is well versed in strategic thinking and leadership skills and in the liaison with senior managers in the pharmaceutical industry.   He is now Managing Director of HCR Belgium, in this position Rafaël manages and leads the HCR Benelux office and the ECCRT.

Stefan Hosten, RN, has a background of 15+ years in Clinical Research as local study coordinator, CRA, Project Manager and Senior Manager Clinical Operations.  He has been actively involved in the development, execution and management of clinical trials in phases I through IV, in national and international context for both pharmaceutical and medical device companies. During his work as Senior Manager Clinical Operations for Cyberonics, he has build up a relevant worldwide experience in developing and presenting of clinical and product-technical training programs. Currently Stefan is owner at ClinOps Consulting.

Monika Huber is working since nearly 20 years in Clinical Research. She was actively involved as local study coordinator, CRA, Clinical Team Manager and Project Manager in Phase II-IV trials and gained extensive experience in monitoring and managing international studies in various therapeutic areas. The coordination of international study teams, the compliance to national and international standards and regulations, as well as the development of management tools have been part of her daily business. Since November 2010 she is Group Compliance Manager of the Harrison Clinical Research Group, and is leading the QM Compliance department since April 2011.

Mr. Andreas Jungk is Rechtsanwalt admitted to the Munich Bar since 1986. For almost twenty years he is providing legal advice to clients in the field of pharmaceutical law. A. Jungk is specialized in elaborating and reviewing national and international contracts concerning clinical trials. He is the author of the reference book “CRO – Verträge in der klinischen Forschung” (“CRO – contracts in clinical research”) containing a CRO – Sponsor model contract inclusive explanations. He is regularly publishing articles about clinical research issues.  He is also invited as speaker and instructor for lectures, seminars and workshops. As a member of the German Institution of Arbitration (“DIS”) A. Jungk participated in national and international Arbitration procedures as Rechtsanwalt and arbitrator.

After obtaining his degree in dentistry from the "Katholieke Universiteit Leuven" in 1980, he started a private practice in Antwerp. After 2 years he returned to academia and worked consecutively at the "Vrije Universiteit Brussel" and the "Katholieke Universiteit Nijmegen" where he obtained a PhD in medicine. Thereafter, he started a career in the pharmaceutical industry in 1988 and worked for approximately 15 years in different positions at Janssen Pharmaceutica (Johnson & Johnson) in Beerse, Belgium. During these 15 years he contributed to the development and registration of different products in different disease areas such as gastro-enterology and psychiatry. In 2003 he switched his career from development towards positions in Operating Companies of different pharmaceutical companies such as Roche, Sanofi-Aventis and Novartis where he participated in the successful launch of different medicines in rheumatology and osteoporosis. At present, he is Clinical Development Director of PharmaNeuroboost, a company which was founded in 2006 and creates New Chemical Entities out of existing therapeutics combined with the company’s proprietary technology. This technology aims to enhance the efficacy of the current standard of care pharmaceuticals used in major psychiatric disorders with a high unmet medical need.

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.

Prof. José Ramet, MD, PhD, is professor at the University of Antwerp and chairman of the Pediatric Departements at the University Hospital. His expertise focuses on new therapeutic strategies (e.g., in autonomic nervous system control mechanisms, artificial ventilation and vaccination) and his research resulted in many publications and new, more effective ventilation techniques in children. He is the first president of the European Board of Paediatrics, secretary-general of the European Academy of Paediatrics, past- president of the European Society of Paediatric and Neonatal Intensive Care, and a member of several scientific societies. He has served on many international and national committees regarding research, training and is member of several Editorial Boards of Journals related to paediatrics.

Dr. Klaus Rose is managing director of klausrose Consulting, Basel, Switzerland, since March 2011. He qualified 1986 in medicine in Berlin after studying Latin languages and psychology. Completed postgraduate clinical training in General Medicine in Germany and England and joined pharmaceutical industry in 1991. Various positions in R&D and medical affairs of progressive responsibility culminating in the position of Global Head Pediatrics at Novartis in 2002 - 2005 and then Global Head Pediatrics at Roche 2005 - 2009. From 2010 until March 2011 he was Principal Consultant with Granzer Regulatory Affairs in Munich, Germany.

Masami Tamura, executive Vice President and COO, International and Regulatory Affairs, CoreMed Corporation. She established CoreMed Corporation, a regulatory and consultancy based in Japan after a career of 15 years in regulatory affairs. She is a member of the Regulatory Affairs Committee of Osaka Pharmaceutical Manufactures Association. She also is a member of TOPRA and serves as a correspondent of the Regulatory Rapporteur and Regulatory Affairs Journal.

Dr Giovanni Valentini holds a Degree in Medicine & Surgery, Magna Cum Laude  from University of “La Sapienza” in 1976 and a Postgraduate qualification of Clinical Pharmacologist, always Magna Cum Laude, from University of “La Sapienza” in 1991. He is presently Head of the Clinical Research Unit 1 - Medical Department R&D Division of sigma-tau . His sound experience in clinical research area allows him to manage with great professionalism the courses of Project Management. He’s Author and co-Author of more than 25 medical publishing, focusing on Clinical Research in Phase I to III, inventor in the United States Patent  US 6,696,492 B1 (Feb 24, 2004) and declarant as expert of the art in the United States Patent US 5,861,434 (Jan 19, 1999). He has recently participated in 2008 as speaker in Rome at the 44th Annual Meeting of the European Association for the study of Diabetes (EASD), presenting the result of clinical trial investigating a new first in class CPT1 inhibitor for the treatment of Diabetes and in 2007 in Chicago at the Acute Heart Failure Syndromes Meeting where he was invited to present the Industry Perspective on Inotropic/Lusitropic Agents and clinical trial design.

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.

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.

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.

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 he has 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.

Gerald Van Roey MPhEd is the Training Manager at the European Centre for Clinical Research Training (ECCRT). He has more than 10 years of experience in Clinical research. As a clinical monitor he has performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development. In his former jobs he implemented different trial tools and mentored junior CRAs. He is now bringing his knowledge and background to practice as trainer for different courses. He has mentored and coached over 1000 clinical research professionals. He is also the author of “Best Practice for Clinical Monitoring” (Pharmimage, ISBN: 978-3-86250-001-7)

Marleen Verbeeck, PhD, is trainer and scientific writer at Harrison Clinical Research. She has international experience in fundamental research and gained solid grounding in clinical monitoring. She is responsible for writing clinical study documents, for developing tailored training modules and for training at operational as well as management level. She has a doctoral degree in molecular biology. Her approach is applying several types of interactive methods to involve trainees for efficient learning. For more than 10 years she has been training clinical research professionals in several European countries and in the United States.

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.

As a specialist in quality management, Ms Verstraeten has a strong scientific background and more than 20 years experience in the pharmaceutical industry from multiple perspectives. This experience is used to provide a broad range of consulting services. She can assist you to conduct risk assessment project around GxP processes. She has proven leadership skills involving managing, developing and motivating teams to achieve their objectives.  She has developed and implemented quality systems integrating different standards and regulations for Pharmaceutical Companies, Contract Research Organization and Non-Profit Organizations. In addition to specific clinical trial audit services (GCP, cGLP, cGMP, DM, CSV, Vendor Qualification and Data Privacy), she can also assist to set up customized training programs , design new Standard Operating Procedures (SOPs) or build quality expertise around medical and promotional communication activities with the aim of improving efficiency across the whole drug development process.
Recently, she gained experience in the evaluation Chinese clinical trials and Belgian inspections. She is member of the BARQA Association (British Quality Assurance Association).

An Vijverman is a partner with the law firm Dewallens & partners, the leading Belgian and European law firm specialised in health law. An’s niche within medical law is data protection, pharmaceuticals and life sciences.  At the core of her practice is the assistance of pharmaceutical companies, and companies active in biotech, medical devices, pharmaceutical research (CRO's), healthcare ICT and processing of medical data.  An has authored a wide variety of publications on various aspects of health care law.  She has also authored "Life Sciences 2010: Belgium" in Getting the Deal Through - Life Sciences 2010 and has co-authored "Chapters on Pharmaceutical Law". An regularly lectures on issues of healthcare law and teaches at Ehsal Management School, Brussels.  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 Belgian Journal of Health law, of the Brussels Pharma Law Group and of the Ethical Committee at the Europa hospitals, Ukkel (Brussels).

Hiroko Yazawa, senior scientist, regulatory affairs, CoreMed Corporation. She has 15 years experience in the pharmaceutical industry. She has extensive experience in clinical development and regulatory affairs. She is a member of Regulatory Affairs Committee of Osaka Pharmaceutical Manufactures Association.