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Session 6 and 7 : Global Convergence in Risk Management Guidance Driving New Innovation Opportunities
Session Chair(s)
Mark Perrott, PHD
Managing Partner, Axian Consulting Ltd., United Kingdom
Ranjeeta Sinvhal, MD
Executive Medical Director, Medical Safety, AbbVie, United States
The session will review the current state of the art in REMS and aRMMs, review, and highlight the convergence of, the most recent and relevant guidance updates from FDA, EMA and CIOMS and propose new ways of collaborative working for the industry to build on the regulatory drivers and provide better support for patients.
Learning Objective : - Describe the key guidance updates that impinge on management of risk
- Discuss the key areas in which the expectations of global regulators are converging
- Construct new operating models that will build on the regulatory approaches and drive better patient outcomes
Speaker(s)
Siobhan Duffy, MS, RPH
Associate Director, REMS Strategy & Submissions, Bristol Myers Squibb, United States
Risk Management in the United States – A Focus on Risk Evaluation and Mitigation Strategies (REMS) | Panelist
Sherice R Mills
Head of US, Axian Consulting Ltd., United States
Presentation: Risk Management in the United States – A Focus on Risk Evaluation and Mitigation Strategies (REMS) | Panelist
Michael Forstner, PHD, MPH, MSC
Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela-Consulting, Switzerland
Considerations for Risk Management Decision-Making, Working with Key Stakeholders, and Implementation Science | Panelist
Jamie Wilkins, PHARMD
Head, Risk Management Center of Excellence, Pfizer Inc, United States
Convergence of EU GVP, US REMS Guidance and CIOMS XII. Opportunities to Strengthen Industry Decision Making, Build Integrated Systems to Support Risk Management and Take a More Global Approach | Panelist
Robert Massouh, MPHARM, RPH
Head of Safety (PV) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom
Implications on Approaches to Risk Minimization Effectiveness Measurement of the New EMA GVP XVI Rev III Guidance, the Addendum on Effectiveness Measurement and the FDA Logic Model | Panelist
Priya Bahri, PHD
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Ongoing Initiatives to Define how a Digital Approach can Support the Achievement of Risk Minimization Objectives | Panelist
Ramon Dempers, MSC
Founder/CEO, Invaryant Inc, United States
The Opportunities of AI in REMS and aRMM, Burden Reduction, Efficiency Improvement | Panelist
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