ExpertFORUM Regulatory Affairs - Towards a faster and more tailored marketing authorisation in Europe and in the US?

- The EU and the US market: parallel or sequential marketing authorisations?
- The Future: breakthrough versus adaptive licensing
- The Present: accelerated/cond. approval, abridged procedures
- Marketing authorisation versus HTA/market access conditions

Are you involved in your company's regulatory strategy? Then you won't want to miss out on this opportunity for a thorough discussion with three outstanding regulatory affairs experts.

This ExpertFORUM focuses on the current challenges when registering new products in Europe and the US.

- How does the marketing authorisation system (including the new option of adaptive licensing) fit with the HTA requirements?
- Are there shortcuts when pursuing an approval in the EU and the US?
- What about orphan drugs in these systems?

Here you'll get first-hand answers and valuable tips for your regulatory strategy

Termin

Datum: 05.03.2015
Ort: NH Frankfurt City
Vilbeler Straße 2
-60313 Frankfurt
Preis: 990,00 EUR zzgl. MwSt.
 

Zielgruppe

This ExpertFORUM addresses the needs of regulatory affairs professionals in the pharmaceutical industry. Especially those who are involved in the regulatory strategy (EU and/or the US) will benefit from the round table.

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