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(Ebook) Pharmacovigilance Medical Writing: A Good Practice Guide by Justina Orleans-Lindsay ISBN 9781119967262, 1119967260

  • SKU: EBN-4433660
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4.5

27 reviews
Instant download (eBook) Pharmacovigilance Medical Writing: A Good Practice Guide after payment.
Authors:Justina Orleans-Lindsay
Pages:286 pages.
Year:2012
Editon:2
Publisher:Wiley-Blackwell
Language:english
File Size:3.19 MB
Format:pdf
ISBNS:9781119967262, 1119967260
Categories: Ebooks

Product desciption

(Ebook) Pharmacovigilance Medical Writing: A Good Practice Guide by Justina Orleans-Lindsay ISBN 9781119967262, 1119967260

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.
*Free conversion of into popular formats such as PDF, DOCX, DOC, AZW, EPUB, and MOBI after payment.

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