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ExpertFORUM Regulatory Affairs

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.
  • 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.

    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!


    50.1171822 8.6872414
Wann 05.03.2015
von 09:00 bis 17:00
Veranstaltungsort NH Frankfurt City
Stadt Frankfurt
Kontaktname
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 vCal
iCal

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!


Direktbuchung

Weitere Informationen über diesen Termin…

FORUM Institut für Management GmbH

Programm

1503236.pdf — PDF document, 177 kB (182,112 bytes)
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