PDF Download Good Pharmacovigilance Practice Guide
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Good Pharmacovigilance Practice Guide
PDF Download Good Pharmacovigilance Practice Guide
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Review
'This is an easy-to-read, practical guide that navigates relevant pharmacovigilance legislation and guidance. It is a valuable single reference for an array of information.'Joshua J Gagne PharmD MS, The Annals of Pharmacotherapy, Volume 43, May 2009 (Joshua J Gagne The Annals of Pharmacotherapy)'This book provides valuable insight to the agency's (MHRA) expectations. Those whose primary role lies outside the area of pharmacovigilance are very likely to benefit from the book because it should help them to better understand the commitments the organization is making to maximise product safety.'Michael R Jacobs, BS PharmD, Doody's Notes, 27th February 2009 (Michael R Jacobs Doody's Notes)
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From the Back Cover
This essential reference guide relates to pharmacovigilance of medicinal products for human use. It complements currently available EU legislation and guidance and provides practical advice to key stakeholders, in particular Marketing Authorisation Holders, about achieving an appropriate system of pharmacovigilance. Contents include: • roles and responsibilities of the EEA Qualified Person for Pharmacovigilance • managing case reports and other safety information • ongoing evaluation of safety data • quality management aspects of pharmacovigilance • managing contracts and agreements • pharmacovigilance beyond the drug safety department The Good Pharmacovigilance Practice Guide is the result of collaboration between different groups within the MHRA, including the GPvP Inspectorate, the Pharmacovigilance Group and the Clinical Trials Unit. By highlighting the areas in which inspection findings are commonly found and providing specific examples of good or poor practice, the guide can assist organisations in developing effective pharmacovigilance systems.
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Product details
Paperback: 232 pages
Publisher: Pharmaceutical Press; 1 edition (November 18, 2008)
Language: English
ISBN-10: 0853698341
ISBN-13: 978-0853698340
Product Dimensions:
6.8 x 0.6 x 9.6 inches
Shipping Weight: 15.5 ounces (View shipping rates and policies)
Average Customer Review:
3.0 out of 5 stars
1 customer review
Amazon Best Sellers Rank:
#421,875 in Books (See Top 100 in Books)
Good Pharmacovigilance Practice guide is a great companion to the VOLUME 9A (Pharmacovigilance for Medicinal Products for Human Use). It gives a comprehensive overview of all key topics given in the manual and is an ideal review book for those dealing in drug safety and EMEA regulations. Each chapter has a section on key inspection/Audit findings that is extremely helpful in practice.Paper and print quality is good and that adds to the reading pleasure. Recommended for Drug Safety specialists, medical and regulatory affairs professionals or simply those interested in Pharmacovigilance.
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