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EMA – Post-authorisation safety studies: questions and answers

22 Jul, 2017 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Real World Evidence

The recently updated EMA page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation safety studies (PASSs). It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked ‘New’ or ‘Rev.’ upon publication.

  1. What is a non-interventional imposed PASS? New July 2017
  2. Under which procedure should I submit my non-interventional imposed PASS? New July 2017
  3. What if the results of a non-interventional imposed PASS make a variation necessary? New July 2017
  4. How shall I present my non-interventional imposed PASS and in which format? New July 2017
  5. To whom should I submit my imposed non-interventional PASS? New July 2017
  6. How do I submit a joint PASS? New July 2017
  7. How will my non-interventional imposed PASS protocol be handled? New July 2017
  8. How will my imposed non-interventional PASS final study report be handled? New July 2017
  9. Scientific advice for safety studies Rev. May 2017
  10. How shall I implement the outcome of a non-interventional imposed PASS final study report procedure? New July 2017
  11. When should I register my studies in the EU PAS Register? New July 2017
  12. Are outcomes of non-interventional imposed PASS published? New July 2017
  13. What fee do I have to pay? New July 2017
  14. Who should I contact if I have questions regarding my submission? New July 2017

[Read More…]
Acknowledgements:

  • Mark Heinemann, Principal Regulatory Specialist, Real World Evidence, inVentiv Health Clinical
  • Mirela Tudor, Senior Regulatory Specialist, Real World Evidence, inVentiv Health Clinical

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