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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