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
