Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.

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

• Overview of the different types of variations and the different procedures for a Marketing Authorizations in the EU
• The different types of variations (Type IA, Type IB, Type II)
• Variations involving product information
• How to deal with unclassified variations
• Line extensions
• Work-sharing

Who Should Attend

This course is specifically designed for personnel in regulatory affairs of pharmaceutical and biotech companies who need to acquire basic knowledge or need to update their knowledge regarding filing variations.

This course will provide you with a comprehensive overview of filing variations, as well as addressing new regulations governing variations to national marketing authorisations and work-sharing which went into effect on 4th August, 2013.

Adriaan Fruijtier, M.Sc.

Specialties: Regulatory

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.

Other Courses:

• European Union Regulatory Issues – New Product Development