The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Risk Management: New Directions
Carla Perdun Barrett, PharmD
Senior Director, Risk Management
PRA Health Sciences , United States
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 Objective : (1) Participants will understand where digital approaches can be leveraged in benefit-risk management (2) They will discover what lessons can be learned from current projects through case studies (3) They will be supported to determine top priority changes in people, process or tech to enable a move to utilise digital approached for REMS and Risk Minimisation in their own organisations
Organizing for Digital Risk Minimization
Helen Edelberg, MD, MPH, FACP
Head of Medical Safety Assessment, Innovative Medicines & Global Safety Risk Mgt
Bristol-Myers Squibb, United States
Preparing for Digital in Benefit-Risk Management: Get Ready for the Revolution
Mark Perrott, PhD
Head of Development Consulting
Pope Woodhead, United Kingdom