ECA - Getting Approval of Generics in the EU and USA

Art-No.: A-1008
Date: 27-28 May 2014

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
12712Getting generics approved in the US - Regulatory procedures and strategic considerations (sections 505(j), 505(b)(2))057
12713Specific dossier requirements for Generic Applications in Europe027
12714Key points to be considered for development of generics - Pharmaceutical Development028
12716Getting Generics approved in the US - GDUFA037
12717Getting generics approved in the US - Key points to consider028
12718eCTD submission in the EU and USA - Differences and best practice068

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