
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
• Selected Titles/Articles of EU Directive 2001/83/EC Relevant
to Pharmacovigilance
• Selected Titles/Articles of EU Regulation No. 726/2004
Relevant to Pharmacovigilance
• Volume 9A of the Rules Governing Medicinal Products in
the European Union: Pharmacovigilance for Medicinal
Products for Human Use
Part I: Guidelines for Marketing Authorisation Holders
Part II: Guidelines for Competent Authorities and the Agency
Part III: Guidelines for the electronic exchange of
pharmacovigilance in the EU
Part IV: Guidelines on pharmacovigilance communication
• Volume 9A Implementation Questions & Answers
from the Eudravigilance Expert Working Group
• ICH Guideline E2B: Note for Guidance on Clinical Safety
Data Management: Data Elements For Transmission of
Individual Case Safety Reports
Click here to see an enlarged pdf cover