European Union Regulatory Issues – New Product Development

This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU.  The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided.

The course will provide the attendee with a thorough knowledge of the following topics:

• How to develop a regulatory strategy
• How to deal with pricing and reimbursement issues in your development
• How to validate your regulatory strategy (scientific advice) and how to choose between centralized and national scientific advice
• When does your product qualify as an orphan medicinal product and what are the advantages if it does?
• How to deal with pediatric development plans
• What has to be considered for Advanced Therapy Medicinal Product and oncology medicinal products

Adriaan Fruijtier is currently Director Regulatory Affairs for CATS Consultants GmbH. Prior to joining CATS, he served as Head of the Oncology Group within the Global Regulatory Affairs division at Bayer AG in Wuppertal, Germany and the Bayer Corporation. He has also worked for the European Medicines Agency in London.

Previously, Mr. Fruijtier served as Director of Regulatory Affairs at Micromet AG and Regulatory Affairs Project Manager at Novartis AG in Basel, Switzerland. He also spent six years as Head of Drug Regulatory Affairs for Ciba-Geigy in the Netherlands.

Mr. Fruijtier received his M.Sc. in Pharmacy from the University of Utrecht, Netherlands.