Trainers’ biographies

 

 

Genevieve Decoster

Genevieve is trained in Pharmacology & Pharmaceutical Medicine and holds an ISO9000 Lead Auditor certificate.

She worked as a Clinical Research Coordinator at the Brussels Free University Cancer Center-Institut Jules Bordet, the New York University Cancer Center, the Ospedale San Giovanni, Bellinzona, and the Free University Hospital Amsterdam.

From 1985 to 2004, Genevieve was at F. Hoffmann-La Roche in Basle where she held several Senior Clinical Research Scientist positions in drug development and pharma marketing. Later, Genevieve was in charge of the implementation of Good Clinical Practice (GCP) for the Roche worldwide clinical trial programs. From 2000 until 2004, she was the Global Head of the GCP Training and Standard Operating Procedures department.

In 2004, Genevieve returned to Belgium where she founded the IT & GCP Consulting Company with the main focus of protecting patients participating in clinical research and obtaining quality clinical trials.

Genevieve is a member of various international scientific organizations and was a board member of the EF-GCP from 1993 until 2004. She is lecturing at the University of Dakar, the University of Abidjan, the Vienna School of Clinical Research, and provides GxP and Clinical Trial Methodology support to investigational sites, contract research organizations and (bio)pharma industry.

She is author or co-author of more than 35 publications in peer-reviewed journals and book chapters.

 

Prof. Jan Hasker G. Jonkman

Originally trained as a pharmacist and as bioanalytical scientist Prof. Dr. Jonkman gained extensive knowledge and experience over the years in clinical pharmacology (especially pharmacokinetics/dynamics and –genetics).

After his scientific training at the University of Groningen (The Netherlands) he was international visiting scientist at the University of California, San Francisco (U.S.A.) and at Food and Drug Administration, Washington D.C. (U.S.A.).

During the past 30 years he performed/supervised over 1,000 Phase I and Phase II clinical studies and 1,250 bioanalytical projects both in the academic and governmental environment and also in independent contract research organisations , working in close cooperation with pharmaceutical and biotech companies.

He is an author or co-author of over 280 publications and gave over 135 lectures on national and international conferences.

More recently he specialised in methodology within clinical pharmacology and especially in all aspects of quality management of drug research including GCP en GLP.

He is acknowledged as ‘Fellow in Clinical Pharmacology’ both by the Dutch Association for Clinical Pharmacology and Biopharmaceutics and the American College of Clinical Pharmacology. He is also awarded as ‘Fellow’ of the American Association of Pharmaceutical Scientists.

Furthermore he is acknowledged as ‘Fellow in Research Quality Assurance’ by the British Association of Research Quality Assurance.

In addition to his scientific experience he also has extensive business experience, both in setting up new companies as well as running medium sized commercial organisations.

He was awarded with the King William I Award for national young entrepreneur of the year (1993) and was acknowledged with regional awards for entrepreneurship in 1995 and 1998.

At present he is Professor in Quality Management of Drug Research and Manufacturing at the University of Groningen (the Netherlands) and president of PharmAdvices , a drug development consultancy company,

 

Dr. Ingrid Klingmann

MD, PhD, is President & CEO of Pharmaplex bvba.

After Medical School at the universities of Ulm and Heidelberg, Germany, Ingrid obtained physician’s specialist degrees in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine. After her hospital and private practice training she joined pharmaceutical industry and later the CRO business. She was responsible for the scientific concept, organisation and management of national and multinational clinical trials of Phases 1 to 4 as well as for drug development planning on the sponsor side, held senior positions in operations and business development before she worked as investigator responsible for two different sites at University College London (UCL). She built European operations for three American CROs and established clinical trial infrastructure for the preparation and management of clinical trials at UCL before she started her own drug development planning and site management support consulting company in Brussels, Belgium. During her whole professional career she was much involved in discussion and promotion of GCP and related regulatory requirements on a national and international basis:

Ingrid was a founding member of AGAH, the German Association for Applied Human Pharmacology, a Board Member and currently President Elect. She also was a founding member of EFGCP, the European Forum for Good Clinical Practice, a Board member, Conference Officer and Co-Chair of both the Ethics Working Party and the “Patients’ Roadmap to Treatment” Working Party. In DIA, the Drug Information Association, Ingrid was Chair of the European Steering Committee, Board Member, and Chair of the DIA EuroMeeting 2005.

Being a Fellow of the Faculty of Pharmaceutical Medicine in the UK and in Belgium, and having the Diploma for Pharmaceutical Medicine in Germany, Ingrid is the responsible lecturer for the Module on Clinical Documentation in the Master for Regulatory Affairs programme at the University of Bonn, Germany and Course Director for the DIA training course on “Essentials of Clinical Study Management”.

Ingrid has organised numerous conferences and workshops aiming at discussing very different practical aspects of Good Clinical Practice and related legislation, the ethical conduct of clinical trials and as well as efficiency in clinical research to develop efficacious and safe new medicines faster and thus providing an opportunity to exchange experience and create new ideas to all stakeholders involved in the clinical research process.

 

Dr. Frank O. Wells

A graduate of the Royal London Hospital, Dr. Wells retired in June 1996 as the Director of the Department of Medicine, Science and Technology of the Association of the British Pharmaceutical Industry.

Whilst at the ABPI he was responsible for providing an interface between the medical profession and the pharmaceutical industry. He specifically had responsibility for advising on standards in clinical research and on the drafting of patient information leaflets, and wrote the 1988 ABPI guidelines on the drafting of leaflets. He now specialises: in good clinical research practice (GCP) matters, having been involved in the original drafting of the EU Directive on Clinical Trials; in ethical issues, including the role of research ethics committees (being Vice-Chairman of the Cambridgeshire 4 Research Ethics Committee and one of the cohort of peer assessors established by the Central Office for Research Ethics Committees); and, especially, in the prevention, investigation and prosecution of research fraud. To that end, he collaborated in setting up the agency known as Medico-Legal Investigations. He has been Chairman of Allington NHS Trust as well as Chairman of Marix Drug Development Ltd, an experimental medicines company based at Llantrisant, near Cardiff. He has recently served as Chairman of the Wales Cancer Bank to which he was appointed by the Wales Assembly Government in October 2003. For 13 years he has served on the Independent Scientific and Ethical Advisory Committee of IMS Health and he co-chairs both the EFGCP Ethics Working Party and its Subgroup on the Structure and Functions of Research Ethics Committees Across the European Union. He is the immediate Past Chairman of the Retired Members Forum of the British Medical Association (BMA)and an elected member of the BMA Council.

Prior to joining the ABPI in 1986, Dr Wells was Under Secretary of the British Medical Association for seven years, and before that for nearly 20 years he was a General Practitioner in Ipswich, Suffolk, during which time he took an active interest in the control of the misuse of drugs, including the abolition of amphetamines and of barbiturates (through the CURB campaign), and in the appropriate use of the newly-introduced benzodiazepines. He is a Fellow of the Royal Colleges of Physicians of both London and Edinburgh, and a Fellow of the Faculty of Pharmaceutical Medicine - of which he has served as a member of the Faculty Board and Founder-chairman of its Ethical Issues Committee. He is a past Chairman of the Society of Pharmaceutical Medicine, on the Committee of which he served for over ten years. He is a Freeman of the City of London and is currently the Chairman-Elect of the Livery Committee of the Worshipful Society of Apothecaries.

He has written many articles on medical research, ethics, and the role of doctors in the community and is co-editor of all four editions of Fraud and Misconduct in Biomedical Research, the latest of which was published in September 2008.


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