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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!

Advance Rates End

DAYS

HOURS

MINUTES

SECONDS

Session 5: Real-World Evidence in Action: Bridging Data for Regulatory Decisions and Drug Safety

Session Chair(s)

Tarek  Hammad, MD, PhD, MS, MSc, FISPE

Tarek Hammad, MD, PhD, MS, MSc, FISPE

Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera

Takeda, United States

The growing role of Real-World Evidence (RWE) in the regulatory landscape is reshaping how drug safety and efficacy are assessed. This session will explore the strategic integration of RWE in regulatory submissions and post-marketing commitments, focusing on case studies and success stories that demonstrate successful utilization of RWE across various stages of the drug development lifecycle. Speakers will discuss the practical implications of the FDA's guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” Emphasis will be on best practices for utilizing EHRs and claims data. The session also addresses RWE’s role in pharmacovigilance, enhancing drug safety monitoring and proactive risk management.

Learning Objective :
  • Understand the regulatory landscape: Examine the key considerations and requirements for utilizing RWE in regulatory submissions, including best practices for data quality, integrity, and alignment with regulatory standards
  • Discuss leveraging the FDA’s latest guidance on EHRs and medical claims data, ensuring compliance and maximizing the value of RWE in regulatory decision-making
  • Describe how RWE can improve drug safety monitoring

Speaker(s)

Marie  Bradley, PhD, MPH, MPharm

Practical Application of FDA Guidance on RWE Including Regulatory Expectations for RWE Quality

Marie Bradley, PhD, MPH, MPharm

FDA, United States

Senior Advisor Real-World Evidence Analytics, OMP, CDER

Judith C. Maro, PhD, MS

Interplay of Adverse Events Spontaneous Reporting and Longitudinal Electronic Health Records for Signal Management

Judith C. Maro, PhD, MS

Harvard Medical School, United States

Assistant Professor, Department of Population Medicine

Wei  Liu

Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies

Wei Liu

FDA, United States

Senior Pharmacoepidemiologist (Oncology Real World Evidence)

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