Get Your Regulatory Affairs Training Bundle

Our expert team has been writing on regulatory issues since 2002.  Now, we have created a bundle of our most recent and widely read regulatory affairs articles to help professionals in the sector better understand the latest issues and the most common problems faced in the sector.

The regulatory affairs training bundle has 40 articles on issues such as:

  • Handling serious breaches of  guideline 536/2014
  • What Marketing Authorisation Holders need to know about outsourcing
  • The role of patients in package leaflet creation
  • A ‘How To’ on Repeat Use Procedures
  • 8 important changes in MDR
  • What is the role of the PRRC in MDR?
  • What you need to know about KASA

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