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Two Day Seminar: The FDA Drug Approval Process (London, United Kingdom - March 22-23, 2018) - Research and Markets

Research and Markets
Posted on: 14 Dec 17

The "The FDA Drug Approval Process" conference has been added to Research and Markets' offering.

This seminar, by a US lawyer with over 40 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA's procedures designed to expedite the testing and approval of new medicines and other topics of current interest.

Gain an understanding of topics such as:

  • Structure and functions of the FDA
  • General regulatory requirements
  • Regulation of preclinical and clinical research
  • New drug application process
  • Biologics (including biosimilars)
  • Generic drugs
  • OTC drugs

Why you should attend

  • Structure and functions of the FDA
  • Historical background
  • General regulatory requirements
  • Regulation of preclinical and clinical research
  • New drug application process
  • Biologics (including biosimilars)
  • Generic drugs
  • OTC drugs
  • Special issues

This meeting will be especially helpful for persons responsible for preparing US registration documents (INDs, NDAs, biologics licence applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The seminar will emphasise issues of interest to innovative manufacturers, but will also deal with issues relating to generic drugs and over-the-counter drugs.

For more information about this conference visit https://www.researchandmarkets.com/research/tkwnr4/two_day_seminar?w=4

View source version on businesswire.com: http://www.businesswire.com/news/home/20171214006205/en/

Business Wire
www.businesswire.com

Last updated on: 14/12/2017

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