Drug Information Association, Renaissance Hotel
Sep 4 2006
The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines
Legislation.The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail.
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. 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.
Decentralized Procedure.
Mutual Recognition Procedure.
National Procedure.
Key Issues to Consider for Business Opportunities.
Regulatory Strategy.
Legal Status of Products and Switching from Rx to OTC.
Medical Devices Legislation.
Clinical Trial Directive.
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