{ Curriculum Vitae }

{ References }
Professional memberships
Dutch Society for Clinical Pharmacology and Biopharmaceutics
International Pharmaceutical Federation (FIP)
American Pharmaceutical Association (APhA)
New York Academy of Sciences
Drug Information Association (DIA)
European Federation for Pharmaceutical Sciences (EUFePS)
Dutch Association of Contract Research Organizations (ACRON)
European Forum for Good Clinical Practice (EFGCP)
Dutch Association of Research Quality Assurance (DARQA)

Pieter J.M. Guelen

Pieter J.M. Guelen is born on September 7th, 1949 in Meijel (L), the Netherlands. After finishing higher grade schools and completing analytical and biochemical training at a level of technical engineer, he worked as research associate and member of the Clinical Pharmacy Group of the Sint Radboud Hospital, University of Nijmegen (head: Prof. Dr. E. van der Kleijn) since September 1969.
He received his pharmacokinetic training at the Catholic University of Nijmegen the Netherlands (Prof. Dr. J. van Rossum, Dr. T.B. Vree and Prof. Dr. E. van der Kleijn), and partially at the Karolinska Institute, Stockholm, Sweden (Prof. Dr. F. Sjoqvist) and the University of Southern California, LA, USA (Prof. Dr. R. Jelliffe).
In the Clinical Pharmacy Group he was responsible for the research into and the therapeutic drug monitoring of anti-epileptic drugs and other psychotherapeutic agents.
The main interest of his research work concerned the pharmacokinetics and metabolism of anti-epileptics and benzodiazepines. Later the accent of these studies was focused on the problems of anti- epileptic drug monitoring in patients.
A larger retrospective pharmacokinetic study was set up in collaboration with the National Epileptic Institute, Oslo, Norway and the National Institute of Health, Epilepsy Branch, Washington D.C., U.S.A. and other epilepsy institutes in Europe, resulting in a book entitled: Rational Anti- Epileptic Drug Therapy (Elsevier, Amsterdam, 1978).

In the years 1975 - 1980

In the years 1975 - 1980 he also was clinical pharmacology consultant for a number of regional psychiatric institutes and hospitals. From January 1980 until March 1984 he worked at Applied Bioresearch Laboratories B.V., Assen, an independent commercial reference and contract research laboratory, where he was head of A.B.L. Drug Studies Unit.

In April 1984

In April 1984 he founded Farma Research, an independent commercial service institute which carries out contract research for the Human and Veterinary Pharmaceutical Industry. This institute, which fully applied to International GLP and GCP conditions, carried out about 60 studies yearly mainly intended for international drug registration. He was CEO in this organization until the beginning of 2000.

Since February 2000

Since February 2000 he is active as independent consultant for the pharmaceutical industry through his independent company Pharmacokinetic Consultancy Services among others involved in clinical and pharmacokinetic study designs and supervision, auditing and training and project management.

In the past decade

In the past decade he audited over 100 clinical sites for phase II-IV studies and over 50 CRO\'s for phase I and bio-availability studies, both study specific or systemic audits for GCP and GLP compliance. Since 2011 he is a free-lance consultant for the WHO essential drug program.

He is author and co-author of a large number of scientific papers and conference proceedings papers and is often invited as speaker, both on scientific conferences and in international institutes.

He is guest teacher on the Catholic University of Nijmegen where he yearly participates as a lecturer in a four week course of Clinical Drug Research, in which he is responsible for the pharmacokinetic and Phase I part and the International ICH-GCP guidelines in relation to clinical drug research.

He also participates as teacher in the European Pharma School in Prague (info www.eps-eu.com) an initiative of the 3rd School of Medicine of the Charles University in Prague and the Cardiff University with special subjects like monitoring, auditing and pharmacokinetics.

He also closely cooperates with the department of Pharmacology of the Charles University in Prague in various research programs.

He was elected chairman of the Dutch Association of Clinical Research Organizations (ACRON) (info www.acron.nl) from 1998 - 2011.

From October 2005 - December 2006 he was the first elected chairman of the newly founded European CRO Federation (EUCROF).

From 2009 - 2011 he was a board member of the Dutch Clinical Trial Foundation (www.clinical-trials.nl).

He is married since 1976, has two sons and two grandsons.