Pharmacovigilance medical writing : a good practice guide /

• Main Author: Orleans-Lindsay, Justina
• Format: eBook
• Language: English
• Published: Chichester, West Sussex, UK : Wiley Blackwell, 2012.
• Subjects: Pharmacoepidemiology.; Writing.; Drug monitoring.; Communication in medicine > Methodology.; Drug Monitoring.; Health Communication > methods.; Pharmaceutical Preparations > adverse effects.; Product Surveillance, Postmarketing.; MEDICAL > Pharmacy.; Electronic books.

Table of Contents:

• Pharmacovigilance medical writing : an overview across the drug development process
• Pharmacovigilance medical writing for clinical trials
• Pharmacovigilance medical writing for CTD submissions
• Pharmacovigilance medical writing in risk evaluation & management
• Pharmacovigilance medical writing for marketed products
• The Ad-Hoc safety review & response to questions document
• The rest of the world.