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Virtual

Jan 24, 2022 8:00 AM - Jan 26, 2022 5:00 PM

DIA Global Pharmacovigilance and Risk Management Strategies Conference

Global Pharmacovigilance and Risk Management Strategies Conference is now fully virtual. Join us from the comfort of your own space!

Session 11: Managing Drug Risks – Regulatory Updates and Industry Perspectives

Session Chair(s)

Annette  Stemhagen, DrPH, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer

UBC, United States

Jo  Wyeth, PharmD

Jo Wyeth, PharmD

Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER

FDA, United States

Identifying and managing risks is fundamental to ensure safe and effective use of drug products. Approaches for Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) may evolve over time based on novel drug products entering the market, technology advances, and availability of new safety information. In this session, industry representatives will join with FDA and EMA to provide regulatory updates, address frequently asked questions, and share perspectives on the future direction for RMPs and REMS.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Integrate RMP and REMS regulatory update information into work practices
  • Identify upcoming changes in RMP and REMS design, interpretation or analysis
  • Synthesize perspectives to inform future REMS and RMP activities

Speaker(s)

Cynthia  LaCivita, PharmD

Speaker

Cynthia LaCivita, PharmD

FDA, United States

Director, Division of Risk Management, OMEPRM, OSE, CDER

Viola  Macolic Sarinic, DrSc, MD, MSc

Speaker

Viola Macolic Sarinic, DrSc, MD, MSc

European Medicines Agency, Netherlands

PRAC Scientific Lead

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