Combination Products Postmarketing Safety Reporting: Overview, Challenges, Solutions

In this webinar...

Combination products, which combine drugs, devices, and/or biological constituent parts, provide innovative diagnostic and treatment solutions but pose postmarket safety implementation challenges for both sponsors and regulators. The 2016 US FDA Final Rule on Postmarketing Safety Reporting for Combination Products became effective January 19, 2017, with a requirement for industry compliance by July 19, 2018. In practice, compliance poses significant challenges, especially for manufacturers of high-volume products, globally marketed products, or more than one type of product.

This webinar will provide an overview of the safety reporting requirements of the final rule and assess the areas that are likely to present the greatest compliance challenges. Real-world, least burdensome approaches to compliant postmarket safety reporting for US and globally marketed combination products will be discussed and industry best practices highlighted. 

Learning Objectives

  • Describe the basic requirements as highlighted in the PMSR final rule
  • Discuss the most challenging aspects of implementing the rule, from both sponsor and FDA perspectives
  • Identify sustainable solutions for compliance with postmarketing safety reporting requirements

Presenters

  • Khaudeja Bano, MD, MS, Senior Medical Director, Medical Affairs, Diagnostics, Abbott Laboratories