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Session 6 and 7: Global Convergence in Risk Management Guidance Driving New Innovation Opportunities (Part I and Part II)
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)
Risk Management in the United States – A Focus on Risk Evaluation and Mitigation Strategies (REMS)
Siobhan Duffy, MS, RPh
Bristol Myers Squibb, United States
Associate Director, REMS Strategy & Submissions
Overview of Current Approaches to Improve Risk Management Decision-Making, Build Tools that Work for Key Stakeholders and Capture Real-Time Data to Support Evaluation
Michael Forstner, PhD, MPH, MSc
SOBI, Switzerland
Head of Global Safety Science
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
Jamie Wilkins, PharmD
Pfizer Inc, United States
Head- Risk Management Center of Excellence
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
Representative Invited
GSK, United Kingdom
Ongoing Initiatives to Define how a Digital Approach can Support the Achievement of Risk Minimization Objectives
Priya Bahri, PhD, RPh
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
The Opportunities of AI in REMS and aRMM, Burden Reduction, Efficiency Improvement
Ramon Dempers
Invaryant Inc, United States
Founder/CEO