Pharmacovigilance Medical Writing - by Justina Orleans-Lindsay (Paperback)

Book Synopsis

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.

Review Quotes

"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)

About the Author

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.