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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!


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.

Keynote Address!

February 6 | 8:15-9:00AM

Keynote Address

Research Integrity in the Quest for Therapies for Alzheimer’s Disease

Matthew Schrag, MD, PhD, Assistant Professor of Neurology at Vanderbilt University and Director of Cerebral Amyloid Angiopathy Clinic


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Highlights & Features

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Who should attend?

  • 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    • Define FDA draft guidance on the Benefit-Risk Assessment for New Drug and Biological Products for Industry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
    • Register

Short Course or Primer

To keep you at the forefront.

Jan 25, 2023

Short Course:

Aggregate Safety Assessment Planning

Feb 01, 2023

Short Course:

Good Pharmacovigilance Practice (GVP) Operations Development - From Clinical Trial to Post Marketing

Feb 05, 2023

Short Course:

Pharmacovigilance and Risk Management Planning

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, DrMed, MD
    Barbara Hendrickson, DrMed, MD Clinical Associate, Pediatric Infectious Diseases
    University of Chicago, United States
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Vice President and Head, Safety Evidence and Sciences
    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 Prior Executive Director, Medical and Drug Safety
    United States
  • Jamie Ridley Klucken, PharmD, MBA, RPh
    Jamie Ridley Klucken, PharmD, MBA, RPh Safety Evaluator, Division of Pharmacovigilance, OSE, CDER
    FDA, United States
  • Mengchun  Li, MD, MPA
    Mengchun Li, MD, MPA Senior Director, Clinical Research, Infectious Disease
    Merck & Co., Inc., United States
  • Annette  Stemhagen, DrPH, PhD, FISPE
    Annette Stemhagen, DrPH, PhD, FISPE Chief Science Officer
    UBC, United States
  • Sarah  Vaughan
    Sarah Vaughan Head of Vigilance Operations
    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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