CV's of Faculty




Jean-Paul Eycken, M.Sc., MBA.  
Jean-Paul Eycken is a bio-engineer holding a MBA. He has more than 20 years of experience in auditing and in quality management for the pharmaceutical and biotech industry. Starting as an auditor for an insurance company, he joined Bristol-Myers Squibb where he used operational auditing techniques for GCP, GLP and cGMP environments. He moved to Pharmaco LSR (currently known as PPD) where he setup the European and later the worldwide QA department. His entrepreneurial spirit led him to setup and manage 4 newly created companies. Two start-up companies were in the biotech area, one in project management and the most recent one is FormaliS in QA management services. FormaliS is present on 4 continents and is a fast growing, high level QA company. FormaliS is consulted by international pharmaceutical, device, biotech and nutraceutical industry for conducting quality management projects.
Theo Helder, D.V.M.  
Theo Helder graduated in Veterinary Medicine in 1975 at the University of Utrecht, The Netherlands. He worked at the University of Utrecht as a pathologist and toxicologist for 11 years.
In 1987 he was appointed Public Health Officer at the GLP Monitoring Authority of the Public Health Inspectorate of the Ministry of Health in The Netherlands. Since December 1991 he has been Head of this Authority.
He was a member of the OECD Working Group on GLP from 1991 till 2010, has been Chairman of this Working Group from 1996 to 1998 and has also chaired various Task Groups on the interpretation and revision of the OECD Principles, as well as Consensus Workshops ("Computerised Systems", "Role and Responsibilities of the Sponsor" and "GLP Archives").
He was the representatieve of The Netherlands in the EU Working Party on GLP and has participated in missions to many countries.
After his retirement in 2010 he has set up a consultancy firm focusing on advising companies on the implementation of Good Laboratory Practice. 
Thijs van Iersel, M.D.  

Thijs van Iersel studied medicine at the University of Nijmegen and graduated in 1993.

He has a Postgraduate Degree in Clinical Pharmacology of the University of Surrey, Guildford, U.K.
After working as a physician in two hospitals he joined the contract research organisation Pharma Bio-Research. Here he was investigator for several Phase I/IIa studies for four years.
Next, he started a career in the pharmaceutical industry (Schering Plough's) where he hold the position of clinical research scientist, section anaesthesiology. He was leader of several international development teams.
After five years he continued his career in the contract research industry, now at Xendo Drug Development in Groningen,were he currently holds the position of Associate Medical and Scientific Director.

In 2011 Thijs swifted again to his former employer in Zuidlaren, now named PRA International.

Prof. em. JanHasker G. Jonkman,
Ph.D., F.C.P., F.Q.R.A., R.Ph.
Originally trained as a pharmacist (1971, University of Groningen, The Netherlands) and as bioanalytical scientist Prof. Dr. Jonkman gained extensive knowledge and experience over the years in clinical pharmacology.
During the past 30 years he performed/supervised over 1,000 Phase I and Phase II clinical studies and 1,250 bio-analytical projects both in academia (University of Groningen, The Netherlands; University of Uppsala, Sweden; University of California, San Francisco, USA) and in the governmental environment (Food and Drug Administration, Washington D.C, USA; GCP-Inspection, The Hague, The Netherlands).
He also performed research in the CRO-environment. He was founder and was executive director of the independent contract research organisation Pharma Bio-Research
(Zuidlaren, The Netherlands) and director at PAREXEL (Berlin, Germany), working in close cooperation with pharmaceutical companies.
More recently he specialised in methodology within clinical pharmacology and especially in all aspects of quality management of drug research including GCP en GLP and acts now as Professor Quality Management in Drug Research and Manufacturing, School of Pharmacy, University of Groningen, The Netherlands.
In 2005 he founded PharmAdvices, a drug development consultancy company.

Prof. Gerard Koëter, M.D., Ph.D.


Prof. Gerard Koëter, M.D., Ph.D. was Chairman of the CCMO (Centrale Commissie Mensgebonden Onderzoek) in The Hague. Gerad Koëter studied medicine at the University of Groningen, the Netherlands and graduated in 1974. Next, he was trained as lung physician at the same university and was certified as such in 1979. In 1988 he was appointed as Professor in Lung Diseases and Tuberculosis at the University of Groningen and as Head of the Department of Lung Diseases and later also of the Department of Internal Medicine at the University Medical Centre Groningen (UMCG). Apart of the above mentioned activities he was in 1984 one of the founders of a research ethics committee in Assen, which now a days is one of the biggest in the country. He has been chairman of the Foundation of this ethics committee for many years.

From 2008 -2014 he was Chairman of the CCMO (Centrale Commissie Mensgebonden Onderzoek) in The Hague.


Marion Kranenborg, Ph.D.  

Marion Kranenborg, Ph.D. is Director Project Management Bioanalysis and Drug Metabolism at QPS Netherlands in Groningen, the Netherlands. Marion received her M.Sc in Chemistry (specialization Biochemistry) at the University of Nijmegen in 1991. In 1997 Marion obtained her Ph.D degree at the University of Nijmegen. From 1998 - 1999 she was Study Director at Pharma Bio Research in Assen. From 1999 on she was scientist at Xendo Laboratories, now QPS, in Groningen, responsible of method development and the execution of bioanalytical methods. 

Rudolf van Olden, Ph. D.  

Rudolf is an MD and Board certified in internal medicine and nephrology. He owned a PhD in nephrology and pharmacology. He joined the pharmaceutical industry in 1998.   

After three years with Nefarma he joined Lilly Netherlands as medical director, responsible for medical affairs, clinical operations, regulatory affairs and pharmacovigilance. In 2007 he joined GSK in the same role in the Netherlands. For 15 years both with Lilly and GSK he was as an industrial sponsor responsible for many clinical trials in different therapeutic areas and clinical phases. In 2016 he was responsible for medical affairs in Europe for cystic fibrosis with Raptor, Horizon and Chiesi Orphan. Since October 2017 he is partner Medical Affairs and Clinical Development with Orphan Now Consulting.

Besides he was chairman of the Dutch Association of Pharmaceutical Medicine and President of the International Federation of Associations of Pharmaceutical Physicians. Currently he is also member of the review committee of the 3rd evaluation of the WMO (Wet Medisch Wetenschappelijk Onderzoek met Mensen).

Willem R. Verweij, Ph.D.  
Willem Verweij is an inspector for clinical studies at the Dutch Health Care Inspectorate.
He graduated from the “Vrije Universiteit” in Amsterdam from his study Biology with specialities in Biochemistry, Microbiology and Immunology. He concluded his PhD research on mixed intra-abdominal infections and abscess formation at the Faculty of Medicine (dept. Medical Microbiology and Parasitology) of the same university with the defence of his thesis in ‘93. Having moved to the northern part of The Netherlands he participated at the University of Groningen as a post-doc in research on the development of an alternative for intra-muscular flu vaccination at the Faculty of Medical Sciences. He then switched to the Faculty of Pharmacy and Pharmaceutical Science to join the research on the development of a potential new anti-sepsis drug. Research during this period lead to phase I and IIa clinical studies by a start-up company that obtained the main patents of this project. After having broadened his knowledge on GCP, Willem then decided to use his scientific knowledge and research experience to contribute to the field of clinical trials and patient safety from the Public Health Supervisory Service point of view. During his first year at the Inspectorate he successfully followed the internal Inspectors Training Program.
Currently, the Clinical Trials and Pharmacovigilance Unit of the Dutch Health Care Inspectorate consists of four inspectors, a supervision officer and an administrative officer, as part of the Product Safety Programme.

Henk W. Visscher, M.Ph.Sc., M.M.Sc.,

Henk is Associate Director Clinical and Research Quality Assurance at Astellas Pharma, Leiden. He is responsible for auditing clinical studies, systems and service providers globally. He is also providing support in health authority inspections and guidance to the clinical development organization on GCP compliance matters and related projects. Prior to joining Astellas Pharma, Henk worked as an Auditor, Global Clinical Quality Assurance at MSD/Merck / Schering-Plough / Organon in Oss and GS Vaccines and Diagnostics in Amsterdam (The Netherlands). Before that he worked in clinical development as a Medical (Safety) Advisor at Organon Teknika in Turnhout, Belgium and as a project coordinator in a Phase I institute (now PRA in Zuidlaren, The Netherlands). He holds university degrees in Pharmacy and Management Sciences.
Lisette Vromans, M.A.  

Lisette Vromans joined Organon's Regulatory Affairs Department as Product Specialist Contraceptives/Scientific Editor in 1986.

She participated in product development teams and carried out all activities necessary to obtain new registrations and maintain existing registrations of these products worldwide (with focus on US, EU and Japan).

In 2005 she joined Organon's Pharmaceutical Regulations Advisory Group. The key role of this group was to collect and interpret regulatory laws and guidances and to inform and give regulatory advice to the organization world-wide.

Lisette represented MSD in several technical committees and working parties at a European and worldwide level.

Currently Lisette is working as a consultant at Zwiers Regulatory Consultancy, providing strategic advice and regulatory operational assistance.

So, Lisette is a real expert in the field of regulatory affairs, and we are very pleased that Lisette will guide us through the difficult area of procedures to get marketing authorization of a new medicine.