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Tutorials:  January 24*
Tutorial #1 – Pharmacovigilance and Risk Management Planning
Tutorial #2 – FDA Adverse Event Reporting System (FAERS): Individual Case Safety Reports (ICSR) and Data Quality
Tutorial #3 – Periodic Benefit-Risk Evaluation Report (PBRER)
Tutorial #4 – Principles and Practice of Pharmacovigilance Governance
*Tutorials require registration and are an additional fee

Conference Dates:  January 25-27

The health care delivery system continues to evolve to provide ever-enhanced value to patients. This requires a shift in regulatory science, tools, realities, and perceptions of biopharmaceutical product benefit-risk across the global pharmacovigilance landscape. It is more important than ever to find ways to fully harness innovation and adopt new technologies to advance pharmacovigilance practices. During this three-day meeting, thought leaders from around the world will provide their insights and engage in dialogue on current and potential new opportunities, operational challenges, and practical aspects, as well as demands in managing product risk in the context of benefits, in the ever-changing world of medical product safety, pharmacovigilance, and global regulations.

This event will provide an unique opportunity for 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 with speakers and interact with colleagues.

Conference Highlights:

  • Global Regulatory Safety Updates
  • New Data Sources for Safety Assessment
  • Current Approaches to Benefit-Risk Assessment
  • Luncheon Roundtable Discussions with Key Thought Leaders
  • Tabletop Exhibits and Networking Opportunities
  • Tutorial Offerings on Sunday, January 24

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Pharmacovigilance and Risk Management Strategies 2017
Tutorials: January 22, 2017
Conference: January 23-25, 2017
Location: Mandarin Oriental, Washington DC

Who should attend?

Intermediate to Advanced Clinical Safety Professionals who are involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Pharmacoepidemiology
  • Customer Engagement Programs, including Patient Support Programs
  • Medical Information
  • Health Outcomes

It is also designed for professionals who work for:

  • Industry: Pharmaceuticals and Biologics
  • Clinical Research Organizations (CROs)
  • Academic Research Centers
  • Regulatory Agencies

Learning objectives

At the conclusion of this conference, participants should be able to:

  • Employ the current regulatory framework for pharmacovigilance in key markets
  • Utilize various aspects of Customer Engagement Programs, such as patient support programs (PSPs) for collection and management of safety data
  • Discuss how advanced therapies and new approaches may impact pharmacovigilance and risk management
  • Describe how new data sources and new technologies effect safety data management
  • Examine new trends and approaches for the safety assessment of biosimilars

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
    Stella C.F. Blackburn, MD Vice President, Global Head of Risk Management, Real World & Late Phase Research
    Quintiles Inc., United Kingdom
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Head Global Drug Safety
    Shire, United States
  • JP  Clement, MD
    JP Clement, MD Executive Consultant
    JP Clement PV Consulting, United States
  • E. Stewart  Geary, MD
    E. Stewart Geary, MD Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ
    Eisai Co., Ltd., Japan
  • LCDR Dipti  Kalra, RPh
    LCDR Dipti Kalra, RPh Safety Evaluator, Division of Pharmacovigilance I, OSE, CDER
    FDA, United States
  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Senior Director, Global Patient Safety, Medical and Benefit Risk Management
    Eli Lilly and Company, United States
  • Robert L. Levin, MD
    Robert L. Levin, MD Director, Division of Pharmacovigilance I, OSE, CDER
    FDA, United States
  • Michael  Richardson, MD, FFPM
    Michael Richardson, MD, FFPM VP International GPV&E and EU QPPV
    Bristol-Myers Squibb, United Kingdom
  • Annette  Stemhagen, DrPH, FISPE
    Annette Stemhagen, DrPH, FISPE Senior Vice President, Safety, Epidemiology, Registries and Risk Management
    UBC, United States
  • Cheryl  Campbell
    Cheryl Campbell Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
    FDA, United States
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