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Hilton Baltimore Inner Harbor

2025 年 01 月 27 日 7:30 上午 - 2025 年 01 月 29 日 12:45 下午

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!

Advance Rates End

DAYS

HOURS

MINUTES

SECONDS

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)

Siobhan Duffy, MS, RPh

Bristol Myers Squibb, United States

Associate Director, REMS Strategy & Submissions

Representative Invited

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

Representative Invited

Adroit Risk Management, LLC, United States

Michael  Forstner, PhD, MPH, MSc

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

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

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

Robert Massouh, MPharm, RPh

GSK, United Kingdom

Head of (Safety) 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

Priya Bahri, PhD, RPh

European Medicines Agency, Netherlands

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)

Ramon  Dempers

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

Ramon Dempers

Invaryant Inc, United States

Founder/CEO

Gita  Toyserkani, PharmD, MBA

Panelist

Gita Toyserkani, PharmD, MBA

FDA, United States

Associate Director, Research & Strategic Initiatives

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