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Bethesda North Marriott Hotel and Conference Center

26 ene 2026 7:00 a.m. - 28 ene 2026 3:00 p.m.

5701 Marinelli Road, North Bethesda, MD 20852

Global Pharmacovigilance and Risk Management Strategies Conference

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

Perspectiva general

Short Course: January 25, 2026 | 8:30AM-12:00PM

Short Course: January 25, 2026 | 1:00-4:30PM

January 26-28, 2026: Conference

Join us for DIA's Global Pharmacovigilance and Risk Management Strategies Conference, the premier event for advancing your expertise in pharmacovigilance and regulatory affairs. Developed in collaboration with regulators and industry experts, this neutral forum provides unparalleled insights into global regulatory harmonization, AI-driven signal detection, and advanced safety analysis tools. At this conference, you’ll hear about updates, opportunities, and challenges shaping the future of drug safety and learn innovative problem-solving strategies that matter most to safety professionals. Attendees will gain actionable knowledge on integrating patient perspectives, optimizing Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), and utilizing real-world evidence (RWE) for regulatory submissions and safety monitoring.

This conference also focuses on cutting-edge methodologies for signal detection, benefit-risk assessment, and addressing safety challenges in special populations. An opportunity not to miss to learn best practices for efficient pharmacovigilance operations, including adverse event reporting, outsourcing strategies, and compliance in resource-constrained settings. Register to attend and connect with industry leaders, regulatory authorities, and patient advocates to drive innovation, stay ahead in drug safety, and achieve excellence in regulatory compliance.

Participant Testimonials

My experience at the DIA conference was both enriching and inspiring. It was an incredible opportunity to learn from industry leaders and experts, gaining fresh perspectives on patient safety and pharmacovigilance. The conference provided cutting-edge insights into evolving safety practices, with thought-provoking discussions that not only deepened my understanding but also sparked new ideas.
What stood out the most was the chance to engage in meaningful conversations and networking—connecting with peers, exchanging knowledge, and collaborating on real-world challenges. The energy in the conference rooms, the shared passion for patient safety, and the willingness to tackle complex issues together made the experience truly memorable. Beyond the wealth of information, the conference reinforced the importance of staying ahead in this rapidly evolving field. I walked away feeling more informed, inspired, and connected. I would highly recommend this conference to anyone in pharmacovigilance who wants to learn, grow, and be part of shaping the future of patient safety. – Balmeet Gurm, MD, Executive Director, Therapeutic Area Lead, Patient Safety, Bristol Myers Squibb

These days the events in PV are very commercial focused while this one is the one which industry can learn, connect, and have some thought leader discussions. - Sivakumar Buddha, Safety Manager, Indegene

Getting a chance to make new connections and deepen the existing ones in the PV community are a reason why I particularly like this conference. – Ranjeeta Sinvhal, MD, Executive Medical Director, Medical Safety, AbbVie

Keynote Address Announced!

January 27 | 8:45-9:30AM

Keynote Address

Session 1: Keynote Address

Dr. Robert Califf is an Adjunct Professor of Medicine at Duke University and a practicing cardiologist. He served as FDA Commissioner (2016–2017) and Deputy Commissioner for Medical Products and Tobacco. At Duke, he was Vice Chancellor for Clinical and Translational Research and founding director of the Duke Clinical Research Institute. A globally recognized expert in cardiovascular medicine and clinical research, he has over 1,200 peer-reviewed publications. Dr. Califf is a member of the National Academy of Medicine and has served on numerous FDA and NIH advisory boards. He co-founded the Clinical Trials Transformation Initiative and led several national research infrastructure programs.

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¿Quiénes deben asistir?

  • Conference Designed for

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

    Objetivos de aprendizaje

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

      • Integrate real-world data and evidence into safety evaluations and regulatory decisions
      • Assess the use of AI, ML, and digital tools for signal detection and safety monitoring
      • Identify effective methods for communicating safety information and benefit–risk outcomes
      • Explain how nonclinical data and NAMs inform early risk assessment
      • Discuss strategies for addressing safety challenges in special populations and small organizations
      • Summarize key global regulatory and policy updates in pharmacovigilance and risk management
      • Apply structured approaches to REMS, aRMMs, and benefit–risk frameworks

    Short Course or Primer

    To keep you at the forefront.

    25 ene 2026

    Short Course:

    Translating Global Risk Management Guidance Into Innovation and Patient Safety

    25 ene 2026

    Short Course:

    Introduction to Benefit–Risk Management

    Comité del programa

    • Mariette  Boerstoel-Streefland, MD, MBA, MS
      Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Patient Safety Officer
      Bristol Myers Squibb, United States
    • Scott  Janiczak, PharmD, MPH
      Scott Janiczak, PharmD, MPH Team Leader, Division of Pharmacovigilance-I, OSE, CDER
      FDA, United States
    • Mark  Perrott, PhD
      Mark Perrott, PhD Managing Partner
      Axian Consulting Ltd., United Kingdom
    • Bethany  Van Veen
      Bethany Van Veen CEO and Founder
      Perspective Pharmacovigilance, United States
    • Ranjeeta  Sinvhal, MD
      Ranjeeta Sinvhal, MD Executive Medical Director, Medical Safety
      AbbVie, United States
    • Michael  Forstner, PhD, MPH, MSc
      Michael Forstner, PhD, MPH, MSc Managing Director, Head of Pharmacoepidemiology Practice
      Mesa Laubela-Consulting, Switzerland
    • Balmeet  Gurm, MD
      Balmeet Gurm, MD Executive Director, Therapeutic Area Lead Cardiovascular and EBs, Patient Safety
      Bristol Myers Squibb, United States
    • Tarek  Hammad, MD, PhD, MS, MSc, FISPE
      Tarek Hammad, MD, PhD, MS, MSc, FISPE Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV
      Takeda Pharmaceuticals, United States
    • Stephanie  Millican, PhD, MSc
      Stephanie Millican, PhD, MSc Deputy Director Benefit Risk Evaluation, Safety and Surveillance
      MHRA, United Kingdom
    • Kal  Elhoregy, RPh
      Kal Elhoregy, RPh Senior Director, Global Risk Management & Pharmacovigilance Compliance
      Amneal Pharmaceuticals, United States
    • Jamie  Wilkins, PharmD
      Jamie Wilkins, PharmD Head, Risk Management Center of Excellence
      Pfizer Inc, United States
    • Yijing (Hellen)  Zhang, MPharm
      Yijing (Hellen) Zhang, MPharm Executive Director, Global Patient Safety
      Beigene, China
    • Session Chair  Invited, BSN, DDS
      Session Chair Invited, BSN, DDS Manager
      DIA, Switzerland
    • Barbara  Hendrickson, DrMed, MD
      Barbara Hendrickson, DrMed, MD Clinical Associate, Pediatric Infectious Diseases
      University of Chicago, United States
    • James  Buchanan, PharmD
      James Buchanan, PharmD President
      Covilance LLC, United States

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