Overview
Tutorial #1 – Pharmacovigilance and Risk Management Planning
Tutorial #2 – FDA Adverse Event Reporting System (FAERS): Individual Case Safety Reports (ICSR) and Data Quality
Tutorial #3 – Periodic Benefit-Risk Evaluation Report (PBRER)
Tutorial #4 – Principles and Practice of Pharmacovigilance Governance
*Tutorials require registration and are an additional fee Conference Dates: January 25-27
The health care delivery system continues to evolve to provide ever-enhanced value to patients. This requires a shift in regulatory science, tools, realities, and perceptions of biopharmaceutical product benefit-risk across the global pharmacovigilance landscape. It is more important than ever to find ways to fully harness innovation and adopt new technologies to advance pharmacovigilance practices. During this three-day meeting, thought leaders from around the world will provide their insights and engage in dialogue on current and potential new opportunities, operational challenges, and practical aspects, as well as demands in managing product risk in the context of benefits, in the ever-changing world of medical product safety, pharmacovigilance, and global regulations.
This event will provide an unique opportunity for dialogue with representatives from FDA and other key regulatory agencies, as well as from industry and academia. There will be multiple opportunities for participants to engage with speakers and interact with colleagues.
Conference Highlights:
- Global Regulatory Safety Updates
- New Data Sources for Safety Assessment
- Current Approaches to Benefit-Risk Assessment
- Luncheon Roundtable Discussions with Key Thought Leaders
- Tabletop Exhibits and Networking Opportunities
- Tutorial Offerings on Sunday, January 24
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Once you’re registered, use the DIA Global app to start preparing for the conference! Download the app to view the agenda and speakers, network with attendees and exhibitors, and get updates throughout the conference. Available for all Apple and Android products – just search “DIA Global” in your app store.
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SAVE THE DATE
Pharmacovigilance and Risk Management Strategies 2017
Tutorials: January 22, 2017
Conference: January 23-25, 2017
Location: Mandarin Oriental, Washington DC
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Program Committee
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William Gregory, PhD Senior Director, Safety and Risk Management
Pfizer Inc, United States -
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Strategy
Consultant, United Kingdom -
Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, United States -
JP Clement, MD Founder and Principal
JPCC Associates, United States -
E. Stewart Geary, MD Senior Vice President
Eisai Co., Ltd., Japan -
Dipti Kalra, RPh Team Leader, Office of Scientific Investigations, OC, CDER
FDA, United States -
Stephen Knowles, MD, MRCP Chief Medical Officer
Halozyme Therapeutics, United States -
Robert L. Levin, MD Lead Medical Officer for Pharmacovigilance Strategy
FDA, 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 -
Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States
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