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January 19-25: Short Courses
January 26-28: Conference

Monitoring of the safety of medicines has always been a top priority for life science companies, regulators, healthcare providers, and patients. The COVID-19 pandemic has created numerous challenges across the healthcare landscape, from patient access to care and the conduct of clinical trials, to data collection for clinical safety and post-market pharmacovigilance, to the need to adapt regulatory expectations to sustain critical care and research while protecting patients and the public.

For pharmacovigilance professionals, the complexity of safety and pharmacovigilance efforts is heightened by the rapid development of multiple vaccines and treatments, the emergent nature of knowledge about the etiology of the corona virus disease, and pervasive misinformation about prevention and treatment practices. The current challenges are ongoing and will have lasting impact on safety, pharmacovigilance, and risk management.

DIA's Pharmacovigilance and Risk Management Strategies Conference provides the foundation for strong strategic planning and practical decision-making in 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.

For this year’s program, stakeholders from medicines research, global regulation, and healthcare will join together to analyze the challenges for safety and pharmacovigilance efforts in this uncertain environment and examine effective strategies for addressing gaps and needs. New approaches and collaborations that build on the foundation of sound pharmacovigilance principles to optimize safety and pharmacovigilance practice and ensure safe medicines for patients will be explored.

It was the BEST CSP annual meeting I've ever attended, of about 6. I really like the diversity of topics, that all world regions were covered, that the latest reg and guidance changes (and upcoming ones) were discussed. I loved that so many from FDA were there and that so many from the EU and other regions were there--so efficient to have everyone together. -Participant Testimonial

The program has been released! Preview all session descriptions, speakers, and more all in one place! View Program

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

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical involved in:

  • Drug Safety
  • Pharmacovigilance
  • Risk Management
  • Clinical Safety
  • Data management and data mining
  • Safety & Risk Management
  • Signal Detection
  • Risk Management
  • Benefit-Risk Assessment
  • Safety Evaluation
  • Regulatory Affairs, Pharmacovigilance
  • PV Governance
  • Safety Surveillance
  • Pharmacovigilance Operations
  • PV Inspection and Audit Readiness
  • Patient Support Programs
  • Market Research Programs
  • Medical Safety
  • Medical Information
  • Pharmacoepidemiology

Learning objectives

  • Describe the impact of innovative designs, rapidly moving development programs, and early authorizations for COVID-19 therapies and vaccines on safety monitoring, safety endpoints, and ongoing signal detection and risk management activities for these products
  • Identify options for addressing potential data “gaps” caused by changes to routine data collection in response to the pandemic situation
  • Identify approaches for measuring the effectiveness of risk management plans (RMPs) and risk evaluations and mitigation strategies (REMS)
  • Discuss the regulatory landscape of safety surveillance for drug products including generics and biologics, including regulatory requirements related to COVID data collection and their wider impact on on post-marketing surveillance
  • Describe the current landscape for pharmacovigilance regulation in Europe, including the upcoming work priorities for MHRA & EMA
  • Gain awareness of potential issues for PV compliance and country-specific expectations for the conduct of pharmacovigilance in the Asia and Latin America regions and how they can be addressed
  • Examine emerging strategies and tools for managing increasing volumes of safety-related data from multiple and new sources

Program Committee

  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Chief Medical Officer
    Halozyme Therapeutics, United States
  • Lesley  Wise, PhD, MSc
    Lesley Wise, PhD, MSc Managing Director
    Wise PV&RM Ltd, United Kingdom
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President Global Drug Safety
    Alexion Pharmaceuticals, Inc., 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 and CMO
    Eisai Co., Ltd., Japan
  • Lisa Melanie Harinstein, PharmD
    Lisa Melanie Harinstein, PharmD Team Leader, Division of Pharmacovigilance, FDA
    FDA, United States
  • Jeremy  Jokinen, PhD, MS
    Jeremy Jokinen, PhD, MS Vice President, Epidemiology, Safety Science, Capabilities and Innovation
    Bristol-Myers Squibb Company, United States
  • Annette  Stemhagen, DrPH, FISPE
    Annette Stemhagen, DrPH, FISPE Senior Vice President and Chief Scientific Officer
    UBC, United States
  • Sarah  Vaughan
    Sarah Vaughan Pharmacovigilance Information Unit Systems Manager
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • Annette S. Williams, MBA, RPh
    Annette S. Williams, MBA, RPh Vice President, Pharmacovigilance
    IQVIA, United States
  • Jo  Wyeth, PharmD
    Jo Wyeth, PharmD Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
    FDA, United States
  • Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
    Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Senior Advisor Regulatory Science
    NEWDIGS at Massachusetts Institute of Technology, United Kingdom
  • William  Gregory, PhD
    William Gregory, PhD Senior Director, Safety and Risk Management
    Pfizer Inc, United States
  • Valerie E. Simmons, MD, FFPM
    Valerie E. Simmons, MD, FFPM Senior Medical Fellow, Global Patient Safety
    Eli Lilly and Company Ltd, United Kingdom
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