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Pharmacovigilance Medical Writing: A Good Practice Guide
Justina Orleans-Lindsay
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Description for Pharmacovigilance Medical Writing: A Good Practice Guide
Paperback. 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). Num Pages: 286 pages, Illustrations. BIC Classification: MMG. Category: (P) Professional & Vocational. Dimension: 216 x 137 x 13. Weight in Grams: 312.
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.
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.
Product Details
Format
Paperback
Publication date
2012
Publisher
John Wiley and Sons Ltd United States
Number of pages
286
Condition
New
Number of Pages
288
Place of Publication
Hoboken, United States
ISBN
9781119967262
SKU
V9781119967262
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50
About Justina Orleans-Lindsay
Justina Orleans-Lindsay BSc, MSc, PhD is a Director of Acadustri (Medical Writing) Limited and Visiting Lecturer in pharmacovigilance at the University of Hertfordshire, UK.
Reviews for Pharmacovigilance Medical Writing: A Good Practice Guide
“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)