Fierce Drug Safety Summit 2023 has ended

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Fierce Drug Safety Summit 2023

9:00am EST

Risk Management/REMS Track Chair Opening RemarksLubna Merchant, MS, PharmD

9:15am EST

Setting the Right Expectations for the Resources and Workload Involved in Developing a REMS ProgramSuzanne Marinello

9:45am EST

Cross-Functional Initiatives for Risk Management Activities Across a Product’s LifecycleCristina Damatarca MD

10:45am EST

Completing the Risk Management Cycle: Risk Management Effectiveness Across US and EUGita Toyserkani, PharmD, MBA • Lubna Merchant, MS, PharmD

11:15am EST

Panel: Successfully Collaborate with Vendors in the Early Stages of REMS Development to Limit Setbacks and Streamline ProcessesJason Ancell MBA, PMP • Michael Carr • Tina Ho • Eleni Samaras Allen, PharmD

1:00pm EST

Best Practices to Consider when Conducting Post-Market Studies and REMS Activities in Combination ProductsKhaudeja Bano

1:30pm EST

Panel: Strategic and Innovative Approaches to Designing and Executing Post Approval Safety StudiesFatima Bhayat • Keele Wurst • David Chonzi • Eniola Ogunmefun

2:30pm EST

Risk Management/REMS Track Chair Closing RemarksLubna Merchant, MS, PharmD

2:45pm EST

END OF RISK MANAGEMENT & REMS TRACK