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