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Book 24:  European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use

Book 24: European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use

$ 15.95

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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

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