Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications

Benefit-risk assessments are typically conducted as part of a regulatory inquiry, for completing the PBRER, the RMP, or as part of an NDA submission. However, benefit-risk assessments are also a crucial part of signal validation and due diligence for making portfolio decisions. This webinar will outline the methodology and conduct of safety benefit-risk assessments for post-marketed products.

There are currently several challenges for companies trying to meet the requirements for benefit-risk assessments. The methodology for identifying and calculating risks and their frequencies in the post-marketing phase is subject to different, varying factors and fraught with caveats. At the end of the day, measuring and defining benefit-risk for a specific product is subjective. This webinar will look at the challenges of conducting benefit-risk assessments at both the portfolio and the product-level to:

• Provide an overview of regulations in the EU and the US requiring benefit-risk assessments
• Determine how to increase transparency with agencies and other stakeholders and discuss why transparency is important
• Examine the consequences of incorrectly assessing benefit and risk

By attending this webinar, you will learn:

• General guidelines for conducting benefit-risk assessments
• Understand regulatory requirements around benefit-risk assessments

Speaker

Mary Mease, RPH, MPH, Senior Director, Risk Management, Quintiles

Mary Mease leads the Safety Knowledge Team, the business strategy for Lifecycle Safety, and the development of strategies and solutions for Risk Evaluation and Mitigation Strategies (REMS). Prior to this Mary spent 11 years at the FDA where she served as an expert at the Center for Drug Evaluation and Research (CDER) on drug benefit risk communication and risk management policies. She guided the establishment and direction of CDER’s Drug Safety Oversight Board and CDER’s benefit risk communication policies and was the Project Officer and Principal Investigator for CDER projects including those evaluating patient, pharmacist, and physician comprehension of CDER’s risk communications and evaluation of a national drug safety survey

Mary has published in professional journals, speaks at industry meetings and has a Masters of Public Health (Johns Hopkins University) and obtained a Bachelor of Science in Pharmacy from the University of Maryland.

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