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Pharmacovigilance Medical Writing: A Good Practice Guide
- Publication Year:
- 2012
- Edition:
- 1st
- Author:
- Orleans-Lindsay, Justina
- Publisher:
- Wiley
- ISBN:
- 978-1-11-996726-2
-
Description
-
Details
Description
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.
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.
Details
- Platform:
- OvidSP
- Publisher:
- Wiley
- Product Type:
- Book
- Author:
- Orleans-Lindsay, Justina
- ISBN:
- 978-1-11-996726-2
- Specialty:
-
- Pharmaceutical Science
- Pharmacology
- Language:
- English
- Edition:
- 1st
- Pages:
- 286
- Publication Year:
- 2012