Hilton Baltimore Inner Harbor

Jan 27, 2025 7:30 AM - Jan 29, 2025 12:45 PM

401 W Pratt Street, Baltimore, MD 21201, USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 6 and 7 : Global Convergence in Risk Management Guidance Driving New Innovation Opportunities

Session Chair(s)

Mark  Perrott, PhD

Mark Perrott, PhD

Managing Partner

Axian Consulting Ltd., United Kingdom

Ranjeeta  Sinvhal, MD

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

Risk Management in the United States – A Focus on Risk Evaluation and Mitigation Strategies (REMS) | Panelist

Siobhan Duffy, MS, RPh

Bristol Myers Squibb, United States

Associate Director, REMS Strategy & Submissions

Sherice R Mills

Presentation: Risk Management in the United States – A Focus on Risk Evaluation and Mitigation Strategies (REMS) | Panelist

Sherice R Mills

Axian Consulting Ltd., United States

Head of US

Michael  Forstner, PhD, MPH, MSc

Considerations for Risk Management Decision-Making, Working with Key Stakeholders, and Implementation Science | Panelist

Michael Forstner, PhD, MPH, MSc

Mesa Laubela-Consulting, Switzerland

Managing Director, Head of Pharmacoepidemiology Practice

Jamie  Wilkins, PharmD

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

Jamie Wilkins, PharmD

Pfizer Inc, United States

Head, Risk Management Center of Excellence

Robert  Massouh, MPharm, RPh

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

Robert Massouh, MPharm, RPh

GSK, United Kingdom

Head of Safety (PV) Risk Management and Benefit/Risk Evaluation

Priya  Bahri, PhD, RPh

Ongoing Initiatives to Define how a Digital Approach can Support the Achievement of Risk Minimization Objectives | Panelist

Priya Bahri, PhD, RPh

European Medicines Agency, Netherlands

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)

Ramon  Dempers, MSc

The Opportunities of AI in REMS and aRMM, Burden Reduction, Efficiency Improvement | Panelist

Ramon Dempers, MSc

Invaryant Inc, United States

Founder/CEO

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