This is a special seminar for Eastern European Regulators and Industry.
Detailed review will be offered on the changed Centralized and Mutual Recognition Procedures and New Decentralized Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described.
The workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs.
Key Topics
•European Union
•Centralized Procedures
•DeCentralised Procedure
•Mutual Recognition Procedure
•National Procedure
•Key Issues to Consider for Business Opportunities
•Regulatory Strategy.