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Getting Biosimilars on the US Market

26.06.2017 17:26
After having attended the seminar you will be aware of the current regulatory framework in the US and know the pitfalls you should avoid in order to launch your products on time.

Termindetails

Wann

25.10.2017
von 09:00 bis 17:30

Wo

München

Kontakttelefon

+49 6221 500-680

Teilnehmer

This seminar should be of interest to all in the pharmaceutical industry involved in
bringing their biosimilar products to the US market. In particular, those working in
regulatory affairs, market access and legal affairs/IP will benefit from the experts' first-hand knowledge.

Termin übernehmen

Do you intend to bring your biosimilar products to the US market? Then you  should not miss out on this seminar. Three experts provide first-hand knowledge on things you should do with regard to:

-regulatory affairs; and
-legal affairs and IP.

After having attended the seminar you will be aware of the current regulatory framework in the US and know the pitfalls you should avoid in order to launch yourproducts on time.

Themen:

- Marketing authorisation approval at the FDA
- Getting ready to launch
- Prelaunch activities under the Bolar amendment
- Patent dispute resolution under the Biosimilar Act
- Practical tips for the US biosimilar applicant

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