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
(ICSRs)
- Guideline on the Use of Statistical Signal Detection
Methods in the Eudravigilance Data Analysis System
EudraVigilance Access Policy for Medicines for Human
Use
• 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
Click here to see an enlarged pdf cover
