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Quality & Regulatory Snapshot

Latest QR News from the PDA Letter

  • Official ICH Training for Q8, Q9 & Q10 in Europe
    March 2010 Training endorsed by the International Conference on Harmonisation (ICH) endorsed training on integrated implementation of the ICH Q8, Q9 and Q10 guidelines will kick off on June 2-4 in Tallinn, Estonia.

  • Meet Hee-Young "Hailey" Park-Our New Intern
    March 2010 I am pleased to meet all of you through the PDA Letter. My name is Hee-Young Park from Korea Food & Drug Administration (KFDA). And some of you might remember me with the English name, Hailey. I became a new family member of PDA at its Bethesda location in December of 2009. I would like to tell you my story.

  • Health Authority Special Report: Interested Parties Briefing Meeting
    February 2010An overview was presented by the European Medicine Agency Inspectors’ Working Group on developments in GMP and related guidance.

  • A Look Back and a Look Forward
    January 2010 It's mid-December as we write this article for the January 2010 issue of the PDA Letter, and believe it or not, the "ought's" of the 21st Century are behind us. Fast forward to December 2009, and like the Roman god Janus, we'll take a look back at some of 2009's significant regulatory happenings and see if we can do a little prediction of what might happen in 2010 as well.

  • Advisory Board Watch: RAQC Activities for 2009
    PDA's Regulatory Affairs and Quality Control Committee (RAQC) is comprised of 23 voting PDA members, with global representative delegations from the Asia Pacific, European and North American regions.

 
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