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Good Pharmacovigilance Practice Guide [Paperback]

£43.40
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eBay item number:176568753998
Last updated on 01 May, 2025 02:52:22 BSTView all revisionsView all revisions

Item specifics

Condition
New: A new, unread, unused book in perfect condition with no missing or damaged pages. See the ...
EAN
9780853698340
UPC
9780853698340
ISBN
9780853698340
MPN
N/A
Item Length
23.9 cm
Subject Area
Commercial Law
Publication Name
Good Pharmacovigilance Practice Guide
Publisher
Pharmaceutical Press
Subject
Medicine
Publication Year
2008
Type
Textbook
Format
Paperback
Language
English
Item Height
244 mm
Author
Medicines and Healthcare Products Regulatory Agency
Item Weight
454 g
Item Width
172 mm
Number of Pages
232 Pages

About this product

Product Information

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.

Product Identifiers

Publisher
Pharmaceutical Press
ISBN-13
9780853698340
eBay Product ID (ePID)
87915171

Product Key Features

Number of Pages
232 Pages
Language
English
Publication Name
Good Pharmacovigilance Practice Guide
Publication Year
2008
Subject
Medicine
Type
Textbook
Author
Medicines and Healthcare Products Regulatory Agency
Subject Area
Commercial Law
Format
Paperback

Dimensions

Item Height
244 mm
Item Weight
454 g
Item Width
172 mm

Additional Product Features

Country/Region of Manufacture
United Kingdom
Title_Author
Medicines and Healthcare Products Regulatory Agency

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