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Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment PowerPoint Presentation
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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 andPharmacoepidemiologic Assessment

CDER / CBER Pharmacovigilance Working Group

working group members
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
workshop agenda
Workshop Agenda
  • Morning
    • Overview
    • Good Pharmacovigilance Practices
    • Presentations, Qs and As
  • Afternoon
    • Pharmacoepidemiologic Assessment
    • Presentations, Qs and As
    • Closing Remarks
scope of concept paper
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
scope of concept paper5
Scope of Concept Paper
  • Focus on risk assessment based on observational data sources
    • Case Reports, Case Series
    • Pharmacoepidemiologic Studies
      • Registries
      • Surveys
what is pharmacovigilance
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

pharmacovigilance why
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
pharmacovigilance why8
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
what is a safety signal
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
what is a safety signal10
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
safety signals
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
what is a pharmacovigilance plan
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
what is a pharmacovigilance plan13
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
active surveillance may involve
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)
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Emerging new safety data may result in ongoing revisions to the sponsor’s pharmacovigilance plan for a product
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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

workshop agenda17
Workshop Agenda
  • Morning
    • Overview
    • Good Pharmacovigilance Practices
    • Presentations, Qs and As
  • Afternoon
    • Pharmacoepidemiologic Assessment
    • Presentations, Qs and As
    • Closing Remarks