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Short Course: January 25, 2023 | Virtual

Short Course: February 1, 2023 | Virtual

Short Course: February 5, 2023 | In-Person

Conference: February 6-8, 2023 | In-Person

DIA's Global Pharmacovigilance and Risk Management Strategies Conference is a neutral event developed by regulators and industry experts discussing the updates, opportunities, and challenges alongside fresh problem-solving strategies that matter most to safety professionals.

  • Meeting Designed for

    • Drug Safety
    • Pharmacovigilance
    • Risk Management
    • Benefit-risk Assessment and Communication
    • Medical Product Safety Assessment
    • Post-Market Studies
    • Real-World Evidence Generation
    • Regulatory Affairs
    • Clinical Research
    • Data Safety Monitoring and Analysis
    • Pharmacoepidemiology
    • Medical Information
    • Medical Communications
    • Medical Affairs
    • Health Outcomes
    • Patient Engagement

  • Learning Objectives

    At the conclusion of this activity, participants should be able to:
    • Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
    • Discuss safety regulatory updates in the U.S, U.K, Europe, Japan, and China
    • Recognize MHRA’s progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities
    • Define FDA draft guidance on the Benefit-Risk Assessment for New Drug and Biological Products for Industry
    • Identify new signal detection tools and reinforce the FMQ method and analysis
    • Evaluate how regulatory differences impact global risk management organizations and design/implementation of risk minimization materials
    • Describe challenges to establishing global approaches to risk minimization and identify risk analysis approaches to developing risk minimization materials
    • Analyze recent advances in the use of AI/ML with respect to safety surveillance
    • Identify the latest strategies for managing literature requirements at local and global level
    • Examine various ways RWE/RWD are utilized in regulatory interactions during clinical development and its role in the evaluation of safety signals arising from clinical trial data
    • Explain safety updates and challenges in special population including pregnancy and lactation and transgender population
    • Discuss challenges with reaching the minority population and barriers for enrollment in clinical trials and recognize the need for a more inclusive approach within the drug development lifecycle
    • Identify potential approaches to address safety challenges in cell and gene therapy and rare disease
    • Recognize key concerns smaller companies have encountered with the FDA Final Rule and discuss FDA’s perspective regarding the concerns of smaller pharma companies

Program Committee

  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Pharmacovigilance
    IQVIA, United States
  • James  Buchanan, PharmD
    James Buchanan, PharmD President
    Covilance LLC, United States
  • Barbara  Hendrickson, MD
    Barbara Hendrickson, MD Clinical Associate Professor
    University of Chicago, United States
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Vice President and Head, Global Risk Management & International Patient Safety
    Bristol-Myers Squibb Company, United States
  • Mamiko  Kasho
    Mamiko Kasho Executive Director, Global PV Management Dept., Global Safety HQs
    Eisai Co., Ltd., Japan
  • Susan  Kindig, JD, MD
    Susan Kindig, JD, MD Executive Director, Medical & Drug Safety
    Halozyme, United States
  • Jamie Ridley Klucken, PharmD, MBA, RPh
    Jamie Ridley Klucken, PharmD, MBA, RPh Safety Evaluator, Division of Pharmacovigilance, OSE, CDER
    FDA, United States
  • Annette  Stemhagen, DrPH, FISPE
    Annette Stemhagen, DrPH, FISPE Chief Scientific Officer
    UBC, United States
  • Mengchun  Li, MD, MPA
    Mengchun Li, MD, MPA Director, Phamacovigilance
    Global Alliance For TB Drug Development, United States
  • Sarah  Vaughan
    Sarah Vaughan Head of Vigilance Development
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Jo  Wyeth, PharmD
    Jo Wyeth, PharmD Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
    FDA, United States
  • Cheryl  Campbell, MS
    Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
    FDA, United States
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