The Impact of EU Regulation 536/2014 (Clinical Trial Regulation) (WS19)

The attendee will be able to:

  1. Compare and contrast how the requirements for CT Supplies in EU Regulation 536/2014 differ from those in Directive 2001/20/EC. 
  2. Identify when EU Regulation 536/2014 became effective by law and when it will become effective in practice.
  3. Explain no fewer than two (2) reasons the Clinical Trial Regulation is being implemented.

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