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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 Scientific Officer and Senior Vice President
  • 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

Speaker(s)

Sebastian Schneeweiss, DrSc, MD

When and How can RWD Analyses Support Regulator Decision-Making

Sebastian Schneeweiss, DrSc, MD

  • Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
  • Harvard Medical School and Brigham and Women's Hospital, United States
Cathy W Critchlow, PhD, MSc

RWE for Drug Development and Regulatory Approvals

Cathy W Critchlow, PhD, MSc

  • Vice President, R&D Data Strategy
  • Amgen, Inc, United States
David Martin, MD, MPH

21st Century Cures and the evaluation of RWE at FDA

David Martin, MD, MPH

  • Vice President, Clinical Safety and Risk Management
  • Moderna, United States
Cathy W Critchlow, PhD, MSc

Panelists

Cathy W Critchlow, PhD, MSc

  • Vice President, R&D Data Strategy
  • Amgen, Inc, United States
Andrew Robertson, JD, PhD

Panelists

Andrew Robertson, JD, PhD

  • Vice President, Head of Global Regulatory Policy and Innovation
  • Takeda, United States

Contact us

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Preconference Short Courses

Short Course 1: Introduction to Pharmacoepidemiology

Short Course 2: Pharmacovigilance and Risk Management Planning

Short Course 3: Reference Safety Information

Short Course 4: Combination Therapies

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