The FDA Drug Approval Process Seminar: London, United Kingdom - 10th, 11th of September 2015
Jun 25, 2015, 04:59 ET
LONDON, June 25, 2015 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/s77rpx/the_fda_drug) has announced the addition of the "The FDA Drug Approval Process Seminar" conference to their offering.
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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.
Delegates will receive a course material folder containing comprehensive documentation provided by the speaker, which will be a valuable source of reference for the future, including a detailed report on the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).
A Certificate of Attendance for Professional Development will be given to each participant who completes the course.
Attendance Limited to 25: This limitation will give participants the opportunity for a thorough discussion of the complex issues to be covered by the programme.
Topics covered at this two day meeting:
- 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
For more information visit http://www.researchandmarkets.com/research/s77rpx/the_fda_drug
Media Contact: Laura Wood , +353-1-481-1716, [email protected]
SOURCE Research and Markets
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