Pharmacovigilance and Risk Management Strategies Conference

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Overview

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