Registration of Pharmaceuticals in the EU

Completely updated for 2011 to reflect the latest changes in pharmaceutical regulatory affairs, this 3-day practical seminar will be of particular benefit to regulatory affairs, clinical, technical and scientific professionals.

Delegates will gain a clear understanding of the current requirements for MA applications in the modular CTD format. Practical exercises will demonstrate the requirements for all parts of the dossier – quality, non-clinical and clinical. Delegates will acquire a good understanding of the changing regulatory requirements and procedures for Active Substance Master Files and Certificates of the European Pharmacopoeia. The use of electronic submissions will also be examined, together with the latest developments in Regulatory Affairs for EU Filings.

The course is designed to provide a practical overview in an informal, interactive atmosphere. The course consists of presentations, group exercises and discussions. During this 3 day course, you will have opportunities to exchange ideas with colleagues from around Europe and beyond, and expand your network of contacts.