Packaging clause in new EU Clinical Trials Regulation it cause for great concern: Annex VI: the challenge of unintended consequences in the EU Clinical Trials Regulation.

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    • Abstract:
      An interview with Joe Monteiro, Technical Account Manager at Essentra Packaging is presented. Topics discussed include the Packaging rule changes in the new EU Clinical Trials Regulation causing concern among new drug sponsors; challenging operational hurdles to the new clinical approvals process, and the reason why this is a problem for drug sponsors.