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Book 24B:  EU 2023 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes

Book 24B: EU 2023 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes

$ 28.95

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This spiral-bound, 400+-page, 8-1/2" x 11" book consists of the Annexes to the EU Good Pharmacovigilance Practice Modules. See the Contents link (above) for specific contents. Its companion volume, Book 24A - GVP Modules, is available for purchase separately or as part of a discounted 2-Volume set under the "Discounted Book Sets" link. 

Who Uses this Book?
• Pharmacovigilance staff
• Clinical Research staff
• Legal/Regulatory/QA staff

What's the Price?
• 1-249 copies:  $28.95             • 250-499 copies:  $27.95
• 500-749 copies: $26.95          • 750+ copies:  $25.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

•  Annex I - Definitions 15Apr14
•  Annex II
   - Templates: Direct Healthcare Professional
      Communication (DHPC)
   - Templates: Cover Page of Periodic Safety Update
      Report (PSUR) (Rev 1)
•  Annex III
   - Guideline on the Exposure to Medicinal Products
      During Pregnancy: Need For Post-Authorisation
   - Guideline on Conduct of Pharmacovigilance for
      Medicines Used by the Paediatric Population
   - Note for Guidance - Eudravigilance Human - Processing
     of Safety Messages and Individual Case Safety Reports
   - Guideline on the Use of Statistical Signal Detection
     Methods in the Eudravigilance Data Analysis System
      EudraVigilance Access Policy for Medicines for Human
•  Annex IV
   - ICH Topic E2A Clinical Safety Data Management:
     Definitions and Standards for Expedited Reporting
   - ICH Guideline E2C (R2) Periodic Benefit-Risk Evaluation
     Report (PBRER)
   - ICH Topic E2D - Post Approval Safety Data Management
     Note for Guidance on Definitions and Standards for
     Expedited Reporting
   - ICH Topic E2E Pharmacovigilance Planning (PVP)
   - ICH Guideline E2F Development Safety Update Report
•  Annex V Abbreviations

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