Overview
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.
"One of the best conferences I have attended. A broad view on how far we have come in the world of PV, why we do what we do, and what is still to come ot meet future needs of patients and managing benefit-risk." - Mary Welke, Trilogy Writing & Consulting, Inc
Join Us Prior to the Start of the Conference!
Check out our infographic with detailed information on our short course offerings on January 26 before the conference begins.
View CoursesPharmacovigilance and Risk Management in 2020: A Global Perspective
With the development of expedited regulatory frameworks in the US, EU, and Japan to address unmet medical needs, traditional clinical safety and pharmacovigilance methods must adapt. Download our exclusive eBook to learn more about international and regional initiatives impacting Pharmacovigilance in 2020.
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Program Committee
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Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Strategy
Consultant, United Kingdom -
William Gregory, PhD Senior Director, Safety and Risk Management
Pfizer Inc, United States -
Catherine Baldridge, MSc Head of Safety
Fusion Pharmaceuticals, United States -
Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, United States -
Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States -
Ingrid N. Chapman, PharmD Senior Risk Management Analyst, DRM, OMEPRM, OSE, CDER
FDA, United States -
Mick Foy Director of Delivery
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom -
E. Stewart Geary, MD Senior Vice President
Eisai Co., Ltd., Japan -
Stephen Knowles, MD, MRCP Chief Medical Officer
Halozyme Therapeutics, United States -
Jill K. Logan, PharmD Safety Evaluator, DPV I, OSE, CDER
FDA, United States -
Barbara Morollo, RN Head, Pharmacovigilance
Corbus Pharmaceuticals, United States -
Michael Richardson, MD, FFPM, FRCP Senior Vice President, WorldWide Patient Safety
Bristol-Myers Squibb, United Kingdom -
Annette Stemhagen, DrPH, PhD, FISPE Chief Science Officer
UBC, United States -
Lesley Wise, PhD, MSc Managing Director
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom -
Hui-Lee Wong, PhD, MS Epidemiologist, Sentinel Central Team, OBE, CBER
FDA, United States -
Jo Wyeth, PharmD Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
FDA, United States
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