Planning a Trial with Safety in Mind

Aggregate Safety Assessment Plan Obstacles and Opportunities

On-Demand Webinar

In this webinar...

This event is a complementary pre-event promotional webinar to help prepare you for DIA’s 2023 Global Pharmacovigilance and Risk Management Strategies Conference. Attendees will connect globally with leaders and professionals in PV, Clinical Safety, MedComms, BioPharma, and beyond. Stakeholders will discuss the opportunities and challenges when using aggregate safety assessment plan as an approach for safety planning.

Learning Objectives:
At the conclusion of this webinar, participants should be able to:

  • Identify key safety topics and requirements for supplemental data collection forms and/or case adjudication
  • Determine when “standard” data analyses are insufficient, and what type of additional analyses and graphical displays are required
  • Recognize knowledge gaps and how to best acquire missing information through collaborative efforts

Session Chairs Presenting:

  • Shyreen Kamal, Pharm.D, Manager, Scientific Programs, DIA

Key Speakers:

  • James Buchanan, PharmD, President, Covilance LLC
  • Barbara Hendrickson, MD, Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc
  • Lothar Tremmel, PhD, Vice President, Quantitative Clinical Sciences and Reporting, CSL Behring