THE EXPERTISE OF PROFESS

• Registration of drugs and certification of medical devices throughout Europe in compliance with current regulatory requirements.
• More than 29 years in organising clinical research with drugs and medical devices throughout Europe.
• Experience in several functions in the Health Care industry, like international medical project leader, medical director and Director Regulatory Affairs and Research.
• Extensive network within the medical profession, with authorities, and within the Health Care industry.
• Expertise is present in many medical fields, e.g. Cardiology, Gynaecology, Oncology, Immunotherapy and Vascular diseases.
• Certified ISO 9000 Lead Auditor IRCA no. AO11064 to assess and evaluate Quality Systems which conform to the requirements of BS EN ISO 9000 and BS 7229/ISO 10011 standards, including Good Clinical Practice standards since December 1996. More than 140 GCP and GLP audits performed since 1994.
• Chief Editor and Author of many chapters in the Handbook entitled International Medical Device Clinical Investigations published by Interpharm Press Inc, Buffalo Grove, IL 60089, USA in December 1997, ISBN 1-57491-054-X.
• Advisor to the Dutch Good Clinical Practice Committee and author of the GCP Handbook for Clinical Trials in the Netherlands.
• Speaker, moderator and trainer on many congresses, seminars and symposia concerning the development of Regulatory requirements in Europe.
• Member of the Governmental Working Party for the implementation of the European Clinical Trial Directive.
• Academic consultant to the Pharmacology Department of the University of Ghent.
• Trainer and advisor to the University Medical Centers of Amsterdam, Maastricht, Leiden, Rotterdam, Nijmegen and Groningen.