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Wednesday, June 19 • 8:00am - 9:00am
#301: Risk Minimization in the EU: New Guidance, New Collaborations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

Learning Objectives

Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

Chair

Priya Bahri, PhD, RPh

Speaker

Industry Update
Meredith Smith, PhD, MPA, FISPE


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Regina Mariam Kamoga

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda
She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →
avatar for Meredith Smith

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session