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.
This audio conference covers:
- How the EMEA works
- How the different gremia work
- Latest update on the centralised procedure
- What is conditional approval good for?
- When is the centralised procedure mandatory?
- When is there an option to use the registration system?
About the speaker:
Ulrich Granzer, PhD owner of Granzer Regulatory Consulting and Services (www.granzer.biz), provides consulting services to pharma and biotech companies for all aspects of drug development and regulatory affairs. Dr. Granzer has extensive experience in the pharmaceutical industry, 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, and several biological compounds directed against the sequelae of stroke, septic shock, and rheumatoid arthritis.
He played a prominent role in development of the first fully human anti-TNF antibody, now marketed as Humira. Dr. Granzer has worked on over 100 NMEs and MNE - submissions in several major indications like HIV, rheumatoid arthritis, asthma, pain, cancer, stroke, tissue regeneration with small molecules and biologicals.
Who should attend?
- Senior Management
- Chief Medical Officers
- Chief Scientific Officers
- Regulatory Affairs Managers
- Business Development Managers
- Legal Counsel
*This conference is rated General interest.