Combination Products Post Marketing Safety Reporting (PMSR): An Expert Panel Discussion on PMSR Challenges and Preparation for Upcoming Reporting Expectations
Lisa Moore, Executive Director, Medical Device and Diagnostics Development, Covance
Hemang Maisuria, Director, Medical Safety & Risk Management; Global Safety Lead, Agios Pharmaceuticals
Susan Neadle, Sr. Director, Global Value Chain Quality Design; Lead, J&J Design Council; Head, J&J Combination Products CoP, Johnson & Johnson
Nataraj Dhananjaya, Director, Safety System & Analytics Drug Safety & Pharmacovigilance, Alkermes
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.
- 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 Sponsors
This virtual panel is brought to you by Covance Patient Safety Solutions and Medical Device & Diagnostics Solutions and PharmaVOICE. Covance Patient Safety Solutions constitutes the clinical trial and post-marketing safety business of Covance and is part of LabCorp, Inc. Covance Patient Safety Solutions provides process, technology and consulting services to the life sciences industry and employs best-in-class strategies, technologies and expertise that accelerates business, drives higher levels of performance, and fosters innovation. As part of the world’s most comprehensive drug development company, Covance Patient Safety Solutions is dedicated to advancing healthcare through a designed around you experience and delivering solutions made real.For more information please visit www.covance.com/patient-safety.