Industry Update on Centralized Procedure in the EU

is being presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and airs on Thursday, January 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

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 centralised procedure works, important points to consider, and 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.

EU Centralized Procedure for Generics

Since its inception in 1995, the centralized procedure has been used for new and biological drugs. Now that the data protection period for the first approvals at EMA is over, generics can be approved in the European Economic Area using the centralized procedure. But does this make sense? What are the alternatives? What is the decision matrix to be used to decide upon the “right procedure”?

This presentation gives answers to these and several more questions on the EMA, the CP and its role in generics approval.

EU Centralized Procedure for Generics is being presented by Dr. Ulrich Granzer, Principal Consultant, Granzer Regulatory Consulting and airs on Tuesday, March 9, 2010. For more details or to register, please visit our site at www.fxconferences.com

An Overview of EMEA & Centralized Procedure

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

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