PharmaVOICE Blog Post

Virtual Panel – Combination Products Post Marketing Safety Reporting (PMSR): An Expert Panel Discussion on PMSR Challenges and Preparation for Upcoming Reporting Expectations

Posted By: Dan Limbach
July 6, 2020

Sponsored by Covance


The PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes. In this virtual webinar, expert panelists will provide an overview of the combination product PMSR final rule, what you need to do to be prepared, common challenges with interpreting the relevant guidances, and offer approaches to comply with the upcoming post-marketing safety reporting (PMSR) ruling for combination products.

Key Learnings:

  • The Combination Product PMSR final rule
  • Implications and challenges for manufacturers
  • Actions and approaches to take to ensure compliance e.g. procedures and infrastructure


About the Blog Poster: Dan Limbach

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