Back to Agenda
Session 4: Turning Guidance into Action -- Practical Pathways for Effective Risk Management
Session Chair(s)
Mark Perrott, PhD
Managing Partner
Axian Consulting Ltd., United Kingdom
Stephanie Millican, PhD, MSc
Deputy Director Benefit Risk Evaluation, Safety and Surveillance
MHRA, United Kingdom
The session will review the impact of recent guidance from FDA and EMA on the practical steps that should be taken when developing an understanding of contextual product risks, defining risk management objectives and then designing, testing and implementing risk management tools. The emphasis of the session will be on practical approaches to align user-tested RM tools to their measures of effectiveness. The session will explore the options and approaches that are available to obtain effectiveness data from traditional cross sectional surveys to real-time, real-world data capture.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define the steps that should be taken to assess product risks in the context of their use within the healthcare system
- Employ a logical approach and framework to define risk management objectives, tools and their measurement
- Describe the key characteristics of different risk management implementation approaches
Speaker(s)
The FDA’s REMS Logic Model: A Framework Linking Design, Implementation, and Evaluation
Gita Toyserkani, PharmD, MBA
DelMetrik, United States
Founder & Principal
Practical Applications of GVP XVI: An Overview of the Outputs of the Recent DIA RM Information Day
Priya Bahri, PhD, RPh
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
Disentangling Regulatory Frameworks to Support Implementation and Assessment of Risk Management Strategies
Representative Invited
GSK, United Kingdom
Risk Management Initiatives in the UK Context
Stephanie Millican, PhD, MSc
MHRA, United Kingdom
Deputy Director Benefit Risk Evaluation, Safety and Surveillance
Have an account?