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Pharmacovigilance Medical Writing: A Good Practice Guide, by Justina Orleans-Lindsay
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Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.
- Sales Rank: #1649486 in eBooks
- Published on: 2012-06-22
- Released on: 2012-06-22
- Format: Kindle eBook
Review
“This book is well structured and should prove useful for pharmacovigilance scientists and writers to have a reference text and checklist for regulatory pharmacovigilance documentation requirements.” (Pharmaceutical Journal, 9 February 2013)
Most helpful customer reviews
0 of 0 people found the following review helpful.
Excellent guide for all safety writers
By Medical Writer
This is a brillient book with each section explained very briefly according to the templates proposed by RA.
Keep up the good work.
0 of 0 people found the following review helpful.
A mere collection
By Rosa, quiltfan
There is very little here that cannot be found in the publicly available legislation.
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