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FDA to Address Industry Questions About Biosimilar Regulations at the Pharma's IQ Immunogenicity Event
Date:4/5/2011

LONDON, April 5, 2011 /PRNewswire/ -- This May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's to discuss FDA directives on immunogenicity introduced in 2008.  

Over the last two years, the regulations have been subject interpretation. Although the regulations were released in 2008, there has been some confusion within the industry as the regulations are subject to interpretation. The confusion arises around the tests have to be developed in order to get approval to develop a drug with a suitable level of immunogenicity.

Joao will provide the attendees with the reviewed FDA regulations and an analysis of the FDA implementation policy. He will also discuss how new FDA guidelines will influence the product development and how companies could make the most out of the pending regulations.

During his presentation, he will also assess the changing regulatory landscape and the practicalities of regulatory approval establishing relationships between immunogenicity assay development studies.

FDA session, Regulatory Update: An FDA Guidance for Industry; Understand Policy and Ensure Assay Development Within the Guidelines, will be part of the 2nd Annual Immunogenicity: Prediction, Detection and Effective Assay Development event, taking part 30 May - 01 June 2011 in Munich.

Other key sessions include:

  • Implementing the correct immunogenicity assay for successful drug development with an A-Z of everything you need to know with Dan Sikkema, GlaxoSmithKline
  • Ensuring global regulatory compliance with key insights from Joao Pedras-Vasconcelos, FDA and Meenu Wadhwa, NIBSC
  • Discovering novel i
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SOURCE Pharma IQ
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