US Regulatory Affairs 2014

A Comprehensive Review of Regulatory Procedures for INDs and NDAs in the US.

5-7 Nov 2014 at Holiday Inn Bloomsbury, London, UK

Health & Fitness, Pharmaceuticals/Drug Discovery

US Regulatory Affairs 2014 5-7 Nov 2014 Holiday Inn Bloomsbury, London, UK
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As drug development becomes a global process, have you had questions about US Regulatory requirements?

Do you wonder why your US colleagues ask for certain documents or information?

This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes.

This course will also enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members.

Participants need to have some knowledge of the ICH and in particular the Common Technical Document (CTD).

Participants will gain a better understanding of the US regulation of investigational new drugs (INDs) and biologics, of the basics of submission of applications seeking marketing approval for a product (NDA & BLA) and post-marketing regulatory requirements in the US.

Member Industry : 1840
Non-Member Industry: 1970
Member Academia/Charitable/Government/Non-profit (Full-time): 920
Non-Member Academia/Charitable/Government/Non-profit (Full-time): 1050

Speakers: Michael R. Hamrell, Carol H. Danielson

From: November 05, 2014 08:00
To: November 07, 2014 18:30

Holiday Inn Bloomsbury, Coram St., WC1N 1HT, London, UK


Health & Fitness, Pharmaceuticals/Drug Discovery

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+44 016 1225 5151

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