Learn about the EMEA, centralized procedure, Directive 2001/83, and how major changes with the EU could affect you.
European legislation, responsible for governing pharmaceutical regulations, has seen major changes in recent years. In 1999, an initiative of the EU Commission culminated in the implementation of a new regulation concerning the structure and name of the European Medicines Agency (EMEA).
Also affected by these sweeping changes was the centralized procedure. Major revisions were invoked concerning fast track, conditional approval and approval under exceptional circumstances. In addition, the basic EU pharma legislation, Directive 2001/83, has been modified to adapt to the needs of the enlarged European Union including 25 full members plus Iceland, Norway, and Liechtenstein.
In this audio conference, Dr. Granzer discusses the changes impacting pharmaceuticals in the EU and how to navigate the maze to get your products to market.
An Overview of EMEA & Centralized Procedure was presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and aired on 2008-04-03. For more details or to download this audio conference, please visit our site at www.fxconferences.com
