Pharmacovigilance medical writing : a good practice guide - Orleans-Lindsay, Justina (Chichester, West Sussex, UK : Wiley Blackwell, 2012)
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.
Includes bibliographical references and index.
Print version record and CIP data provided by publisher.
Keywords: Pharmacoepidemiology; Writing; Drug monitoring; Communication in medicine -- Methodology; Pharmacoepidemiology; Writing; Drug Monitoring; Health Communication -- methods; Pharmaceutical Preparations -- adverse effects; Product Surveillance, Postmarketing; MEDICAL -- Pharmacy; Electronic books