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Overview

January 10: Short Course
January 12: Short Course
January 14: Short Course
January 24-26: Conference

For pharmacovigilance professionals, the complexity of monitoring safe medicinal practices are heightened by the rapid development of multiple vaccines and treatments, the emergent nature of knowledge regarding COVID-19, and pervasive misinformation about prevention and treatment practices. Current challenges will have lasting impacts on safety, pharmacovigilance, risk management, and more.

DIA's Global Pharmacovigilance and Risk Management Strategies Conference was developed by recognized experts from the biopharmaceutical industry and global regulatory agencies. This conference provides the background, context, and opportunities to discuss current challenges alongside fresh problem-solving strategies that matter most to professionals working in the field.

2022's Global Pharmacovigilance and Risk Management Strategies Conference invites stakeholders from medicines research, global regulation, and healthcare will join to analyze current challenges for safety in pharmacovigilance efforts, and examine effective strategies for addressing gaps and needs. These new approaches and collaborations build on the foundation of sound pharmacovigilance principles to optimize safety and pharmacovigilance practice, and ensure safe medicines for patients in a global and regional context.


Who should attend?

Who should attend?

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

  • Drug safety/ Pharmacovigilance
  • Risk management, including Risk Evaluation and Mitigation Strategies (REMS)
  • Benefit-risk assessment and communication
  • Medical product safety assessment
  • Post-market studies and Real-world evidence generation
  • Regulatory affairs
  • Clinical research
  • Data safety monitoring and analysis
  • Pharmacoepidemiology
  • Medical information, Medical Communications, Medical Affairs
  • Health outcomes
  • Customer Engagement Programs, including Patient Support Programs

It is also designed for professionals who work in the settings of:

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

Learning objectives

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

  • Describe the requirements for the use, management, and documentation of the reference safety information (RSI) in clinical trials and how they are enforced by regulatory agencies
  • Identify the key descriptive and analytical statistics, their use in interpreting measures of risk, and how estimands can be applied to safety analyses
  • Analyze, implement pharmacovigilance inspection preparedness
  • Discuss the factors which predict susceptibility to believe misinformation and identify potential interventions to reduce the sharing of misinformation
  • Outline the key principles and skills necessary for an effective communication strategy
  • Examine the complexities in management of sudden peaks and unprecedented volume of adverse events, discover solutions to deal with sudden peaks in volumes
  • Discuss current-state and potential future applications of AI in PV as well as the regulatory challenges and implications
  • Recognize challenges and opportunities that occur in prospective pregnancy registries and bring to understanding drug safety during pregnancy
  • Integrate RMP and REMS regulatory update information into work practices

Program Committee

  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Chief Medical Officer
    Halozyme Therapeutics, United States
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Pharmacovigilance
    IQVIA, United States
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President Patient Safety, Chief Safety Officer
    AstraZeneca, United States
  • James  Buchanan, PharmD
    James Buchanan, PharmD President
    Covilance LLC, United States
  • Cheryl  Campbell, MS
    Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
    FDA, United States
  • E. Stewart  Geary, MD
    E. Stewart Geary, MD Senior Vice President
    Eisai Co., Ltd., Japan
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Vice President and Head, Global Risk Management & International Patient Safety
    Bristol-Myers Squibb Company, United States
  • Jamie Ridley Klucken, PharmD, MBA, RPh
    Jamie Ridley Klucken, PharmD, MBA, RPh Health Scientist, Division of Pharmacovigilance, OSE, CDER
    FDA, United States
  • Linda J. Scarazzini, MD, RPh
    Linda J. Scarazzini, MD, RPh Vice President, Pharmacovigilance and Patient Safety
    AbbVie, United States
  • Sarah  Vaughan
    Sarah Vaughan Head of Vigilance Development
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Annette  Stemhagen, DrPH, FISPE
    Annette Stemhagen, DrPH, FISPE Senior Vice President and Chief Science Officer
    UBC, United States
  • Jo  Wyeth, PharmD
    Jo Wyeth, PharmD Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
    FDA, United States
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