Pharmacovigilance medical writing
Subtitle: a good practice guide
By: Justina Orleans-Lindsay
Publisher: John Wiley & Sons Inc.; Wiley-Interscience; Wiley-Blackwell
Published: 2012
Place of publication: Chichester, West Sussex, UK
Language: eng
Number of pages: 288
ISBN-13: 9781119967262
Subjects: Pharmacoepidemiology; Pharmaceutical Preparations; Postmarketing Product Surveillance; Methods; Drug Monitoring; Writing; Adverse effects; Health Communication
Notes: Includes bibliographical references and index.
Table of contents: title: Pharmacovigilance medical writing : an overview across the drug development process; title: Pharmacovigilance medical writing for clinical trials; title: Pharmacovigilance medical writing for CTD submissions; title: Pharmacovigilance medical writing in risk evaluation & management; title: Pharmacovigilance medical writing for marketed products; title: The Ad-Hoc safety review & response to questions document; title: The rest of the world.