On June 13th, 2007 AMIA convened an invitational workshop on Pharmacovigilance. The meeting included presentations about key drug safety and pharmacovigilance initiatives. AMIA worked closely with the Clinical Data Interchange Standards Consortium (CDISC) and Health Level Seven (HL7) and several major pharmaceutical companies to plan the meeting. The agenda included presentations and panel discussions from the federal government, academia, and the pharmaceutical industry. The objectives of the meeting were to:

• review the goals, accomplishments and experiences of key initiatives of different organizations in utilization of healthcare data for pharmacovigilance;
  
• determine if there are synergies, gaps or duplications; and
  
• identify opportunities to work on specific projects or activities which would further our common goals of enhancing pharmacovigilance and improving patient safety.
  

Presentation Materials

Pharmacovigilance: The Need, Promises & Pitfalls
Richard Platt, HMS

Opportunities and Challenges in Leveraging Observational Data for Pharmacovigilance
Patrick Ryan, GSK

NHIN Slipstream Project: Safety Surveillance Using Electronic Health Records
John Apathy, Accenture and Louisa Walsh, AstraZeneca

Consumer Perceptions on Drug Safety - Major Survey Findings
Axel Olsen, PhD Pharmaceutical Safety Institute

CDISC and Pharma – the RFD Project
Michael Ibara, Pfizer and Landon Bain, CDISC

Improving the Safety "System" by Bridging Clinical Point-of-care with Postmarket Medical Product Safety
Michael Ibara, Pfizer

eHI Pharma Communities Project
Emily Welebob, Consultant, Project Lead

Practical Implications of PV in Clinical Practice
David Bates, Partners Healthcare

Perspectives on Pharmacovigilance Issues
Amy Patterson, NIH

Panel: Opportunities and Innovation For Patient Safety. What Are The Priorities? How Can We Collaborate Together Most Effectively?
Charlie Barr, Roche; Doug Fridsma, AMIA GTB Project; Becky Kush, CDISC; Chuck Jaffe, HL7

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Meeting Sponsors

• GlaxoSmithKline
  
• Pfizer
  

Technical Assistance

• AMIA
  
• CDISC
  
• HL 7
  
• Pharmaceutical Safety Institute