ExpertFORUM Regulatory Affairs
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Towards a faster and more tailored marketing authorisation in Europe and in the US? 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.50.1171822 8.6872414
| Wann |
05.03.2014 von 09:00 bis 17:00 |
|---|---|
| Veranstaltungsort | NH Frankfurt City |
| Stadt | Frankfurt |
| Kontaktname | Dr. Henriette Wolf-Klein |
| Kontakttelefon | 0621/500680 |
| 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. |
| Termin übernehmen |
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Topics
- 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
Aims and objectives
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 afairs experts. This ExpertFORUM focuses on the current challenges when registering new products in Europe and the US.
- How does the marketing authorization 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 frst-hand answers and valuable tips for your regulatory strategy!
Weitere Informationen über diesen Termin…
FORUM Institut für Management GmbH
Programm
1503236.pdf
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PDF document,
177 kB (182,112 bytes)
