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January 26: Short Courses
January 27-29: Conference

DIA's Pharmacovigilance and Risk Management Strategies Conference provides the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs. Developed by recognized experts from the biopharmaceutical industry and global regulatory agencies, this conference provides the background, context, and opportunities to discuss current challenges and to problem-solve around issues that matter most to professionals working in the field.

This year’s conference will address the current thinking on predicting and assessing risks such as drug-induced liver injury, and the assessment of expectedness of serious adverse reactions during clinical development. The complexities of assessing benefit-risk balance of today’s therapies, including immunotherapy and other advanced therapies, will be examined. Experts will present approaches and engage in dialogs around more extensive and impactful uses of real world data and generation of RWE for safety assessments. A full-day will be devoted to the development, implementation, and assessment of risk management strategies for drugs approved in multiple regions, with a special in-depth coverage of REMS in the US.

In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements.

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
  • Regulatory Affairs
  • Clinical Research
  • Pharmacoepidemiology
  • Post-Market Studies and Real World Evidence Generation
  • Customer Engagement Programs, including Patient Support Programs
  • Medical Information, Medical Communications
  • Health Outcomes

It is also designed for professionals who work for:

  • Industry: Pharmaceuticals, Biologics, Combination Products, Devices
  • Clinical Research Organizations, Contract Service Organizations
  • Academic Research Centers
  • Regulatory Agencies
  • Government Research Programs

Learning objectives

At the conclusion of this conference, participants should be able to:
  • Apply the current regulatory framework for pharmacovigilance in key markets, including the US and the changing EU
  • Discuss the impact of current pharmacovigilance conditions, regulatory requirements, and recent developments in India, China, and Japan on safety and pharmacovigilance practice in those markets
  • Describe new ICH and CIOMS pharmacovigilance projects underway and their importance to evolving best practices in patient engagement and safety data collection
  • Discuss current research findings on mechanisms of risk such as drug-induced liver injury (DILI) and their impact on assessing benefit-risk associated with therapies, including new and advanced therapies
  • Compare and contrast risk management tools, such as REMS and RMPs, approved by various regulatory agencies; and discuss risk management strategies that have achieved successful implementation in a complex global setting
  • Explain new approaches for surveilling medication errors and effective methods to prevent and reduce these errors
  • Describe new approaches and opportunities to use RWE for safety assessment and evidence generation

Program Committee

  • Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
    Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Vice President, Global Head of Early Access and Risk Management
    IQVIA, United Kingdom
  • William  Gregory, PhD
    William Gregory, PhD Senior Director, Worldwide Medical and Safety
    Pfizer Inc, United States
  • Catherine  Baldridge, MS
    Catherine Baldridge, MS Owner, Principal Consultant
    Essential Pharmacovigilance, LLC, United States
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Global Drug Safety
    Alexion, United States
  • Cheryl  Campbell, MS
    Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
    FDA, United States
  • Ingrid N. Chapman
    Ingrid N. Chapman Risk Management Analyst, DRISK, OMEPRM, OSE, CDER
    FDA, United States
  • Mick  Foy
    Mick Foy Head of Pharmacovigilance Strategy
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • E. Stewart  Geary, MD
    E. Stewart Geary, MD Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ
    Eisai Co., Ltd., Japan
  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP President, Drug Safety, and Pharmacovigilance
    Halozyme Therapeutics, United States
  • Jill K. Logan, PharmD
    Jill K. Logan, PharmD Safety Evaluator, DPV I
    Office of Surveillance and Epidemiology (OSE), CDER, FDA, United States
  • Barbara  Morollo
    Barbara Morollo Pharmacovigilance and Risk Management Consultant
    United States
  • Michael  Richardson, MD, FFPM
    Michael Richardson, MD, FFPM 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
  • Lesley  Wise, PhD, MSc
    Lesley Wise, PhD, MSc Managing Director
    Wise Pharmacovigilance and Risk Management Ltd, United Kingdom
  • Hui Lee  Wong, PhD, MS
    Hui Lee Wong, PhD, MS Epidemiologist, OBE, CBER
    FDA, United States
  • Jo  Wyeth, PharmD
    Jo Wyeth, PharmD Postmarket Safety Program Lead, DMEPA, OSE, CDER
    FDA, United States
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