Webinar Series: Post-Market Safety Issues

The safety of medical treatments is of paramount importance in the regulatory approval process, and conducting robust studies and surveillance to ensure treatments continue to be safe for patients once on the market is also vital. Evidera recently conducted a series of webinars focused on post-approval safety issues to share insights into regulatory changes, lessons learned, and best practices that can help you enhance your knowledge and planning of these types of studies. Whether your product may need a risk evaluation and mitigation strategy (REMS), or you need to plan for post-authorization studies in multiple nations or specifically for risk mitigation in Europe, or your product requires a pregnancy registry or lactation study, you can gain helpful insights from Evidera experts in these areas.

Access our Safety Series on-demand webinars below:

PASS Lessons Learned – Insights on Multinational Studies

Speakers:
Javier Cid, MD, DRPH, MBA, MSC, Research Scientist, RWE
Beth Nordstrom, PhD, MPH, Sr. Research Scientist, RWE, & Exec. Dir., Center of Excellence for Epidemiology

Hot Topics for Risk Evaluation and Mitigation Strategy (REMS) Programs

Speakers:
Kristin Veley, PharmD, MPH, Research Scientist and Director, REMS & Pregnancy Registries, RWE
Sheila Weiss, PhD, FISPE, Sr. Research Leader, Drug Safety, RWE
Robin Kinard, Senior Director, Risk Management Programs

Post-Authorization Safety Studies (PASS) for the Evaluation of Risk Minimization in the EU: From Regulatory Framework to Successful Implementation

Speaker:
Annalisa Rubino, PhD, Senior Research Scientist, RWE

Pregnancy Registries and Lactation Studies: Best Practices to Support Product Labeling

Speaker:
Deborah Covington, DrPH, Executive Director, Real-World Evidence

Back to Top