European legislation governing pharmaceutical regulations has undergone a major revision in recent years. It began with an initiative of the EU Commission in 1999, and culminated in the implementation of a new regulation concerning the structure and the name of the EMEA, the European Medicines Agency.
These sweeping changes also affected the centralised procedure, with major revisions regarding fast track, conditional approval and approval under exceptional circumstances. Furthermore, the basic EU pharma legislation, Directive 2001/83, has been changed 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 will discuss the changes impacting pharmaceuticals in the EU, and how best to navigate the maze in getting your products to market.
This audio conference is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting. For more details, please visit our site www.fxconferences.com
