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Good Pharmacovigilance Practice Guide
Great Britain: Medicines and Healthcare Products Regulatory Agency
€ 49.99
€ 48.32
FREE Delivery in Ireland
Description for Good Pharmacovigilance Practice Guide
Paperback. Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines. This text provides practical advice about achieving an appropriate system of pharmacovigilance. Num Pages: 240 pages. BIC Classification: MMG. Category: (P) Professional & Vocational. Dimension: 243 x 173 x 13. Weight in Grams: 454.
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 ... Read more
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 ... Read more
Product Details
Publisher
Pharmaceutical Pr
Number of pages
240
Format
Paperback
Publication date
2008
Condition
New
Number of Pages
232
Place of Publication
London, United Kingdom
ISBN
9780853698340
SKU
V9780853698340
Shipping Time
Usually ships in 5 to 9 working days
Ref
99-50
Reviews for Good Pharmacovigilance Practice Guide
'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 ... Read more
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