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Good Pharmacovigilance Practice Guide - Softcover

Great Britain: Medicines And Healthcare Products Regulatory Agency

 
9780853698340: Good Pharmacovigilance Practice Guide
Softcover
ISBN 10: 0853698341 ISBN 13: 9780853698340
Verlag: Pharmaceutical Press, 2008

Inhaltsangabe

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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Von der hinteren Coverseite

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 departmentThe 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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Verlag
Pharmaceutical Press
Erscheinungsdatum
2008
Sprache
Englisch
ISBN 10 
0853698341
ISBN 13 
9780853698340
Einband
Taschenbuch
Auflage
1
Anzahl der Seiten
232
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
Nicht verfügbar