This spiral-bound, 5" x 7.5" book consists of Volume 9A of the Rules Governing Medicinal Products in the European Union on Pharmacovigilance. Volume 9A is presented in four parts:
• Part I deals with Guidelines for Marketing Authorisation Holders;
• Part II deals with Guidelines for Competent Authorities and the
Agency;
• Part III provides the Guidelines for the electronic exchange of
pharmacovigilance in the EU; and
• Part IV provides Guidelines on pharmacovigilance communication.
Who Uses this Book?
• Pharmacovigilance staff
• Clinical Research staff
• Legal/Regulatory/QA staff
What's the Price?
• 1-249 copies: $15.95 • 250-499 copies: $14.95
• 500-749 copies: $13.95 • 750+ copies: $12.95
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
This spiral-bound, 400+-page, 8-1/2" x 11" book consists of the finalized EU Good Pharmacovigilance Modules that replace Volume 9A of the Rules Governing Medicinal Products in the European Union on Pharmacovigilance. Several modules are under development and are not included in this book. See the Contents link (above) for specific contents. Its companion volume, Book 24B - GVP Annexes, 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: $26.95 • 250-499 copies: $25.95
• 500-749 copies: $24.95 • 750+ copies: $23.95
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
Click here to see an enlarged pdf cover