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Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. CDER / CBER Pharmacovigilance Working Group. Group Leads: Julie Beitz Mark Goldberger Miles Braun Project Manager: Patrick Guinn. Kathy Miracco Yi Tsong Edward Cox Dan Shames

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Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

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  1. Risk Assessment of Observational Data: Good Pharmacovigilance Practices andPharmacoepidemiologic Assessment CDER / CBER Pharmacovigilance Working Group

  2. Group Leads: Julie Beitz Mark Goldberger Miles Braun Project Manager: Patrick Guinn Kathy Miracco Yi Tsong Edward Cox Dan Shames Susan Lu Joyce Weaver Marianne Mann Judy Staffa Carol Holquist Min Chen Melodi McNeil Ralph Schmid Working Group Members • Jeff Siegel • Bette Goldman • Jerry Davis • Roselie Bright • Mary Beth Jacobs • Support: • Aileen Ciampa • Jane Axelrad • Virginia Beakes • Nichelle Cherry • Jane McCarthy

  3. Workshop Agenda • Morning • Overview • Good Pharmacovigilance Practices • Presentations, Qs and As • Afternoon • Pharmacoepidemiologic Assessment • Presentations, Qs and As • Closing Remarks

  4. Scope of Concept Paper • Present FDA’s preliminary thoughts on: • Important pharmacovigilance concepts • Safety signal identification • Pharmacoepidemiologic assessment and interpretation of safety signals • The development of pharmacovigilance plans

  5. Scope of Concept Paper • Focus on risk assessment based on observational data sources • Case Reports, Case Series • Pharmacoepidemiologic Studies • Registries • Surveys

  6. What is Pharmacovigilance? All post-approval scientific and data gathering activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other product- related problems This includes the use of pharmacoepidemiologic studies

  7. Pharmacovigilance: Why? • At the time of approval, clinical trial data are available on limited numbers of patients treated for relatively short periods • Once a product is marketed, large numbers of patients may be exposed, including: • Patients with co-morbid illnesses • Patients using concomitant medications • Patients with chronic exposure

  8. Pharmacovigilance: Why? • After marketing, new safety information may become available: • Through use of the product domestically or in other countries • Through use of other drugs in the same class • From preclinical studies • From pharmacologic studies • From controlled clinical trials

  9. What is a Safety Signal? • An apparent excess of adverse events associated with use of a product • Even a single well-documented case report may be viewed as a signal

  10. What is a Safety Signal? • Preclinical findings or experience with other products in the class may be sufficient to generate a signal, even in the absence of case reports in patients • A product’s risk profile may be characterized by several safety signals

  11. Safety Signals • Are identified • From case reports, other sources • Are evaluated • In pharmacoepidemiologic studies, registries, surveys • Are interpreted • In the context of all available safety information • Are monitored • Through enhanced pharmacovigilance efforts

  12. What is a Pharmacovigilance Plan? • A plan proposed by a sponsor • for the ongoing evaluation of safety signals identified with the use of a product • to monitor at-risk populations which have not been adequately studied • Plan may be developed at the time of product launch or after a signal is identified

  13. What is a Pharmacovigilance Plan? • A sponsor’s plan may involve: • Expedited reporting of serious adverse events of interest • Submission of adverse event report summaries at more frequent, pre-specified intervals • Conduct of additional observational studies or clinical trials • Implementation of active surveillance activities to identify as yet unreported adverse events

  14. Active Surveillance May Involve... • Product-based activities • Follow cohorts of patients exposed to specific products • Setting-based activities • Surveillance of healthcare settings (e.g., EDs) for events likely to present there • Event-based activities • Monitor registries for events that are often drug-related (e.g., liver transplant registries)

  15. Emerging new safety data may result in ongoing revisions to the sponsor’s pharmacovigilance plan for a product

  16. While additional safety information is being developed, FDA will work with sponsors to: • communicate information about safety signals and • minimize events occurring in users of a product through risk management programs1 1Concept Paper: Risk Management Programs

  17. Workshop Agenda • Morning • Overview • Good Pharmacovigilance Practices • Presentations, Qs and As • Afternoon • Pharmacoepidemiologic Assessment • Presentations, Qs and As • Closing Remarks

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