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Omni Shoreham Hotel

Jan 28, 2019 7:00 AM - Jan 30, 2019 3:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

Session 7: Generating Real World Evidence (RWE) Fit for Regulatory Decisions: Learning from Safety

Session Chair(s)

Annette  Stemhagen, DrPH, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer

UBC, United States

Robert  Reynolds, DrSc, MSc, FISPE

Robert Reynolds, DrSc, MSc, FISPE

Vice President, Epidemiology, Worldwide Regulatory and Safety

Pfizer Inc, United States

Tools and expertise exist in pharmacovigilance to ensure that real world data meet the necessary quality standards for regulatory decisions. Studies are already being designed in accordance with current best practices to reduce bias and produce valid results. This session builds on the long standing use of RWE in PV to provide lessons, case studies, and guidances relevant to the goal of developing a broader framework for integrating RWE in regulatory decision making.

Learning Objective : Upon completion of this session, the participant should be able to:
  • Describe the common uses of RWE in pharmacovigilance and risk management
  • Summarize the key scientific criteria for evaluating the quality of RWE for regulatory decisions
  • Identify circumstances where RWE may appropriately supplement drug development


Sebastian  Schneeweiss, DrSc, MD

When and How can RWD Analyses Support Regulator Decision-Making

Sebastian Schneeweiss, DrSc, MD

Harvard Medical School and Brigham and Women's Hospital, United States

Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology

Cathy W Critchlow, PhD, MSc

RWE for Drug Development and Regulatory Approvals

Cathy W Critchlow, PhD, MSc

Amgen, Inc, United States

Vice President, R&D Data Strategy

David  Martin, MD, MPH

21st Century Cures and the evaluation of RWE at FDA

David Martin, MD, MPH

Moderna, United States

Vice President, Global Head RWE

Cathy W Critchlow, PhD, MSc


Cathy W Critchlow, PhD, MSc

Amgen, Inc, United States

Vice President, R&D Data Strategy

Andrew  Robertson, JD, PhD


Andrew Robertson, JD, PhD

Takeda, United States

Vice President, Head of Global Regulatory Policy and Innovation

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