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.

This audio conference covers:

• How centralized procedure works for generics
• The timeframe for the procedure
• Marketing options for a centrally approved generic
• The efforts and timing to submit a valid application to the EMA
• The new structure of the EMA

About the speaker:

Ulrich Granzer, PhD, is owner of Granzer Regulatory Consulting and Services (www.granzer.biz), providing consulting services to pharma and biotech companies on all aspects of drug development and regulatory affairs. Dr. Granzer has extensive industry experience, having held senior positions at Glaxo, BASF Pharma - Knoll, and Bayer. He has been involved in the development and registration of products targeting HIV, asthma, pain, chemotherapy induced emesis, several biological compounds directed against the sequelae of stroke, septic shock, and rheumatoid arthritis.

Dr. Granzer also played a significant role in development of the first fully human anti TNF antibody, now marketed as Humira. He has worked on more than 100 NME's and MNE submissions in several major indications such as HIV, rheumatoid arthritis, asthma, pain, cancer, stroke, and tissue regeneration with small molecules and biologicals.

Who should attend?

• Regulatory Affairs Directors and Managers
• Legal Counsel
• Heads and Managers of Business Development
• Heads and Managers of Marketing and Sales
• Senior Management