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Tuesday, June 26 • 2:00pm - 3:15pm
#251: Risk Management: New Directions

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will hear from experts involved in digital risk minimization programs. They will describe how, following a Pharmacovigilance Risk Assessment Committee (PRAC) assessment report, a pilot was initiated to assess the feasibility and operational impact of developing and implementing digital additional risk minimization measures. The session will describe how a digital approach can support tool currency, continuous availability, and educational effectiveness. It will also cover aspects of internal vision development, global and local cross-functional collaboration, tool design, regulatory authority interactions, and the critical importance of change management.

Learning Objectives

Identify opportunities for developing digital risk-benefit communications; Describe the organizational aspects of developing digital strategies from the lessons of ongoing programs; Describe the key impacts on people, process and tech in the move to utilise digital approaches for REMS and risk minimization that could be applied to their own organizations.


Carla Perdun Barrett, PharmD


Organizing for Digital Risk Minimization
Helen Edelberg

Preparing for Digital in Benefit-Risk Management: Get Ready for the Revolution
Mark Perrott, PhD

avatar for Carla Barrett

Carla Barrett

Sr Director, Patient Safety Risk Mgmt, PRA Health Sciences
Dr. Carla Barrett is Senior Director, Risk Management at PRA Health Sciences. Carla has over 20 years of pharmaceutical industry experience (Wyeth, Pfizer, Allergan) in the strategic and operational aspects of pharmacovigilance risk management programs for products in development... Read More →
avatar for Helen Edelberg

Helen Edelberg

Head of Medical Safety Assessment, Innovative Medicines & Global Safety Risk Mgt, Bristol-Myers Squibb
Dr Helen Edelberg is Head of Med Safety Assmt for Innovative Med & Gbl Safety Risk Mgmt, which provides authoritative expertise on development & execution of rigorous & innovative risk mgmt strategies at BMS. A strategic & innovative biopharmaceutical exec & physician with ~20 years... Read More →
avatar for Mark Perrott

Mark Perrott

Head of Development Consulting, Pope Woodhead
Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session