7th FORUM Conference on Marketing Authorisation

The 7th FORUM Marketing Authorisation conference and seminar focuses on the EU & global challenges for regulatory affairs. The conference on day one addresses the new regulatory documents as well as the challenges for global regulatory submissions.

#Has the new Variations Regulation simplified the system?
#Did the Paediatrics Regulation achieve its goal?
#How will the paediatric sessions be included in the SmPCs according to the new guideline?
#What consequences will the Bioequivalence Guideline have for the generics industry?
#What are the current challenges for the industry and the agency in terms of global regulatory affairs?

The seminar on day two focuses on the strategical and practical aspects of the planning and performance of a DC or MR procedure. What are delaying and accelerating factors in this field? (Familiarity with the procedures is presumed here.) May we invite you to take part in the discussion with speakers from various agencies and the industry?

Themen

- Harmonisation of the marketing authorisation dossier - Country specialities! - Multiple/duplicate applications - Delaying & accelerating factors