ExpertFORUM Regulatory Affairs - Challenges in the EU - This first-hand information you'll need for 2016/2017

- Early access and HTA assessment - how do they fit together?
- Orphan drugs - the upcoming challenges
- Freedom of information provision - what does this mean for regulatory affairs?
- IDMP - are you ready for implementation?
- Generics marketing authorisation - convergence beyond the EU?

Your regulatory affairs work is becoming more and more challenging, because you increasingly need to interact with clinical development, market access, legal department, IT and further departments. This meeting gives you first-hand information on your tasks in regulatory affairs itself and in cooperation with your neighbouring departments.

Benefit from the latest news, presented by experts from the industry and regulatory authorities, and be prepared for your new duties, e.g. the IMDP implementation.

Termin

Datum: 14.07.2016
Ort: Capri by Fraser
Europa-Allee 42
-60327 Frankfurt
Preis: 990,00 EUR zzgl. MwSt.
 

Zielgruppe

This meeting addresses the needs of regulatory affairs professionals working in the pharmaceutical industry in Europe. Everyone with a working knowledge of marketing authorisations is invited to join the discussion on NCEs, NBEs, Generics and Orphans.

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Zerfallszeittester / Disintegration Tester DISI