Our Trainers - European Centre for Clinical Research Training
 

Barbara Schnurr holds a PhD in dietetics/oncology from the University of Vienna, Austria. Dr. Barbara Schnurr is also a certified Quality Systems Manager and Session Chair of the Quality Assurance Working Group of the BVMA. Before joining the CRO industry in 1996 as a medical monitor, Dr. Schnurr worked as a research fellow in the Intensive Care and Surgical Unit of the University Clinic Mannheim/Heidelberg. In 1997 she accepted the position of Chief Quality Assurance Manager at Harrison Clinical Research in Munich, Germany. Under her supervision, the company was certified according to ISO 9001 in 1998. Dr. Schnurr is member of the Austrian Association for Clinical Nutrition, the German Organisation for Nutrition Medicine, the Association of Austrian Nutrition Scientists, and the German Association for Quality.

Marleen Verbeeck, PhD, is training manager of the ECCRT 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.
 
Gerald Van Roey joined the ECCRT in 2009. He has 9 years experience in clinical research in a wide variety of companies. He has performed studies in pharmaceutical, biotech, device and CRO surroundings 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.

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. 

Francis P. Crawley is the general director of the Good Clinical Practice Alliance (Brussels, Belgium) and a WHO Expert in ethics. He is a philosopher specialised in ethical, legal, and regulatory issues concerning biomedical research. He has acted as an author or expert for leading international and European ethics guidelines, as well as for several in-country guidelines in Asia, Africa, the Americas, and Europe. He is currently chairman of the Ethical Review Committee of the International Network for Cancer Treatment and Research, a member several international societies and also serves on several editorial boards for international journals (Applied Clinical Trials, the International Journal of Pharmaceutical Medicine, Good Clinical Practice Journal, and the Journal of Empirical Research on Human Research Ethics). He is an Honorary Member of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, United Kingdom.

Anne-Marie Georges has a Ph.D. in Molecular Biology and has been involved in the development of vaccines for GSK for over 30 years. She is chairperson of the Regulatory Affairs Working Group of the European Vaccine Manufacturers Association and lectures in various universities and conferences on this topic.

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.

Elizabeth Ursell holds a PhD from University of Southampton, UK in developmental biology and a BSc in Molecular biology from University of Sheffield, UK. She joined Verius Ltd in 2006 as their pharmacovigilance manager. She is responsible for all pre and post-marketing safety services conducted by Verius Ltd. Dr Ursell has previously worked with global pharmaceutical companies and Contract Research Organisations. She is currently a member of the Pharmaceutical information and Pharmacovigilance association, the Institute of Clinical Research and the International society of Pharmacovigilance.
  

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.  
  

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.  
  

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.  
  
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).
  
Daniela Marcozzi holds a PhD in Biology from the University La Sapienza of Rome, Italy and she is certified for  QMS Auditor 1st & 2nd Part ISO 9001:2000 Training Course (BVQI)  and QMS Auditor 3rd Part Lead Auditor (IRCA) Training Course (BVQI). In 2008 she has Certification released from GIQAR (Italian Group of QA in Research) as GLP/GCP/GMP Auditor. From 1993 dr Daniela Marcozzi is working in Clinical Quality Assurance department of sigma-tau i.f.r. S.p.A. and from 1999 she is Head of Clinical Quality Assurance for the company. She is member of SSFA Society for Applied Pharmacological Sciences and of GIQAR Italian Group for Quality Assurance in Research. She is member of BARQA, of AFI and she belongs  to the following Expert Groups as GCP Group in quality of coordinator, ISO 9000, CSV, and GMP in R&D as coordinator and Pharmacovigilance QA. Dr Daniela Marcozzi is largely requested for numerous presentations and/or chairman at international and national Event on Good Clinical Practice, Good Manufacturing Practice, Audit, QA Management and Computerized System Validation, and Co-author of the volume:"La Sperimentazione Clinica in Italia" (Clinical Trials in Italy) - Edizioni Micon (October 1998).  She is a trainer for the Introduction to GCP auditing course in Italy, Milan.
 
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
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.
 
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.
 

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.

Peter Conrath has a Ph.D. in sciences and has been working for Harrison Clinical Research since May 2009. He started his career as a CRA for several years within the CRO environment. Growing further into the Clinical Project Manager role his valuable experience in each step of the clinical research process, within a CRO and pharmaceutical industry, serve as the sound platform for the current training courses.
  

Werner Stilmant holds a MSc in Biology and a MBA (Vlerick Management School). He started his career within the area of Clinical Data management, transferred to a leading biochemicals producer as account manager, went back to the clinical research environment as CRA and through his MBA studies touched ground with the pharmaceutical supply chain as a logistic cold chain expert. Based on his experience, he transferred to a leading logistic provider as Head of Supply Chain Management focusing on concepts as Lean Operations and general management. While his interest kept heavily focused towards the pharmaceutical industry, Werner took the opportunity in 2008 to join Harrison Clinical Research Benelux as Managing Director. Currently he is assigned as MD for both Harrison Clinical Research Benelux and ECCRT, while also fulfilling the function of Regional Director (Benelux, UK and France). His career clearly provides him a broad base to initiate and provide training in different fields.