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Good pharmacovigilance practice guide / compiled by the Medicines and Healthcare products Regulatory Agency.

Material type: TextTextPublisher: London : Pharmaceutical Press, [2009]Copyright date: copyright 2009Description: xviii, 211 pages ; 25 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 9780853698340
Subject(s): DDC classification:
  • 21 615.7 G.
Online resources:
Contents:
1. EEA Qualified Person Responsible for Pharmacovigilance; 2. Management of Pharmacovigilance Data; 3. Spontaneous Case Processing; 4. Literature Searching; 5. Periodic Safety Update Reports; 6. Evaluation of Safety Data; 7. Risk Management Plans; 8. Reference Safety Information; 9. Quality Management System; 10. Interactions Between Pharmacovigilance and Other Functions; 11. Contracts and Agreements; 12. Safety Reporting for Clinical Trials.
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Holdings
Item type Current library Collection Call number Status Date due Barcode
Books Books Main library A11 Pharmacy ( Clinical Pharmacy ) 615.7 G. (Browse shelf(Opens below)) Available 00003645

Includes index.

1. EEA Qualified Person Responsible for Pharmacovigilance; 2. Management of Pharmacovigilance Data; 3. Spontaneous Case Processing; 4. Literature Searching; 5. Periodic Safety Update Reports; 6. Evaluation of Safety Data; 7. Risk Management Plans; 8. Reference Safety Information; 9. Quality Management System; 10. Interactions Between Pharmacovigilance and Other Functions; 11. Contracts and Agreements; 12. Safety Reporting for Clinical Trials.

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