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Tutorials: January 25, 2015

Tutorial 1:
Pharmacovigilance and Risk Management Planning
Tutorial 2: Introduction to Pharmacoepidemiology and Applications in Premarketing and Postmarketing Surveillance, Risk Management and Value Demonstration
Tutorial 3: PBRERs
Tutorial 4: Pharmacovigilance System Master File

Benefit-Risk in 2015! Regulatory science, tools, realities, and perceptions of biopharmaceutical product benefit-risk continue to evolve across the global pharmacovigilance landscape. During this three-day meeting, thought leaders from around the world will provide their insight and engage in dialogue on current opportunities and challenges in managing product risk in the context of benefit. The current regulatory framework will be outlined and practical approaches to protecting patient safety will be discussed.

This event will provide a unique setting for informal dialogue with representatives from FDA and other key regulatory agencies, as well as from industry and academia. There will be multiple opportunities for participants to engage speakers and interact with fellow colleagues.

Meeting Highlights

  • Keynote Presentation by Professor Stephen Evans of the London School of Hygiene & Tropical Medicine
  • Luncheon Roundtable Discussions
  • Tabletop Exhibits
  • Pre-meeting Tutorial Offerings

Who should attend?

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

  • Pharmacovigilance
  • Drug safety
  • Risk management
  • Medical product safety assessment
  • Regulatory affairs
  • Clinical research
  • Data analysis
  • Pharmacoepidemiology
  • Medical information
  • Health outcomes

It is also designed for professionals who work for:

  • Industry: pharmaceuticals and biologics
  • Clinical Research Organizations
  • Academic Research Centers
  • Regulatory Agencies

Learning objectives

At the conclusion of this meeting, attendees will be able to:

  • Describe the current regulatory framework for pharmacovigilance in key markets
  • Discuss global implications of the Pharmacovigilance System Master File
  • Explain basic risk minimization interventions, measures of their effectiveness, and integration into selected health care systems
  • Describe new approaches for safety assessment of biosimilars in early clinical development
  • Examine the role of Real World Evidence in assessing product risk in the context of benefit
  • Discuss the impact of health literacy on risk communication

Program Committee

  • William W. Gregory, PhD
    William W. Gregory, PhD Senior Director, Worldwide Safety and Regulatory Pfizer Inc, United States
  • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
    Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Vice President, Global Head of Risk Management Quintiles Inc., United Kingdom
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Head, Global Safety and Pharmacovigilance Baxter International Inc. , United States
  • Jean-Pierre  Clement, MD
    Jean-Pierre Clement, MD Vice President Global PV and Medical Risk Management Cubist Pharmaceuticals, Inc., United States
  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Senior Director, Global Patient Safety Eli Lilly and Company, United States
  • Michael  Richardson, MD, FFPM
    Michael Richardson, MD, FFPM International Head GPV&E and EU QPPV Bristol-Myers Squibb, United Kingdom
  • Tracy M Salaam, PharmD
    Tracy M Salaam, PharmD Safety Evaluator Team Leader, CDER FDA, United States
  • Stewart  Geary, MD
    Stewart Geary, MD Senior Vice President, Chief Medical Officer Eisai Co., Ltd., Japan
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Contact us

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199

Event Logistics
Ellen Diegel, Event Planner
Phone +
Fax +1.215.442.6199

Tabletop Exhibit
Jeff Korn, Exhibits Associate
Phone +1.215.442.6184
Fax +1.215.442.6199