Risk Evaluation and Mitigation Strategies (REMS) play a critical role in ensuring that the benefits of certain therapies outweigh their risks, but they are often misunderstood, inconsistently interpreted, and challenging to operationalize.
In this fireside chat, former FDA and MMS REMS expert Somya Dunn discusses how REMS are viewed, designed, and evaluated from an agency perspective. The panel will explore the fundamentals sponsors need to understand, common misconceptions that arise during development programs, and how to approach REMS planning with greater clarity and confidence.
This session is designed to help sponsors move beyond surface level understanding and gain practical insight into how REMS function in real regulatory decision making.
Speakers
- Somya Dunn – Senior Medical Director, Safety Risk Management, MMS Holdings – Former FDA
- Jeffrey Wiese – Senior Director, Safety and Risk Management, MMS Holdings
- Mark Bernath – Business Development Director, MMS Holdings
Watch This Webinar To:
- Gain clarity on how New Drug Applications are evaluated on the need for a REMS
- Understand the core REMS components including elements to assure safe use (ETASU)
- Avoid common REMS misinterpretations that can introduce regulatory risk
- Learn practical considerations for designing effective REMS programs for NDA submission and for practical clinical implementation
- Better align REMS strategy with overall development and risk management objectives
What You Will Learn:
- How REMS are viewed and evaluated by regulators
- The fundamental REMS elements sponsors need to get right
- Common misconceptions that can create avoidable regulatory friction
- Practical insights to support more effective REMS planning and execution
- How to align REMS strategy with broader development and risk management goals
Who will benefit from attending?
- Regulatory Affairs and Regulatory Strategy leaders
- Clinical Development and Clinical Operations professionals
- Safety, Pharmacovigilance, and Risk Management teams
- Biotech and Pharma sponsors navigating REMS requirements
- Sponsors preparing for IND, NDA, or BLA submissions involving REMS
FAQs
- Will a recording be available?
Yes, a recording will be provided to all registered attendees following the live session. - Who is this webinar for?
This webinar is intended for biotech and pharmaceutical professionals involved in regulatory strategy, safety, and clinical development who want a clearer understanding of REMS from an agency perspective.
Register Now
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