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Session 2: Advancing RMP Effectiveness Through Evidence, Expectations, and Digital Innovation
Session Chair(s)
Helen Fiddes
Head of Country Pharmacovigilance, UK and Ireland
Bristol-Myers Squibb, United Kingdom
Session Overview: This session will explore the practical application and evaluation of Risk Minimisation Measures (RMMs) within the UK environment, focusing on both regulatory expectations and real-world implementation. Speakers will discuss how ARMM effectiveness is assessed, what “good” looks like from an MHRA perspective, and common challenges in ensuring meaningful patient and HCP impact. The session will also highlight the future of educational materials, showcasing how digital solutions - from QR codes to app-based resources - can support more accessible, efficient, and modern risk minimisation strategies.
Speaker(s)
ARMMs Effectiveness Checks
Robert Massouh, MPHARM, RPH
GSK, United Kingdom
Head of Safety (PV) Risk Management and Benefit/Risk Evaluation
What does the MHRA expect? Implementation of RMMs
Kathryn Ord
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Assessor in Pharmacovigilance
Digitalization of Educational Materials: General Aspects and Case Example
Louise Okeeffe
Roche Products Ltd., United Kingdom
Senior PV Process Director
Digitalization of Educational Materials: General Aspects and Case Example
Payal Gupta
Roche Products Ltd, United Kingdom
Patient Safety Partner
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