8th FORUM Conference on Marketing Authorisation

What are the challenges in regulatory affairs for 2012?

At the conference 6 experts will give you a thorough update on the challenges and possibilities through
#the Pharma Package
#the extension of the Variations Regulation to purely national variations
#the HMA roadmap
#the inclusion of HTA topics in regulatory affairs
and much more.

The seminar on day two focuses on the strategic 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 economy?

Themen

- Essential points in the planning - Country specialities! - Multiple/duplicate applications - Delaying & accelerating factors - Tasks for the CMDh