Industry Update on Centralized Procedure in the EU

The revised EU pharma legislation has seen some major changes since coming into force, changes that have now been implemented and, more importantly, interpreted. New and additional guidelines have been issued, a system of scientific advisory groups (SAG) has been established, and the procedure to obtain a marketing authorization is being performed in a more stringent way.

In this audio conference we discuss how the paediatric regulation has created the necessity for a more extensive planning process and in particular, how line extensions of existing products are concerned.

Industry Update on Centralized Procedure in the EU is being presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting and airs on Thursday, April 30, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

An Overview of EMEA & Centralized Procedure

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