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
