Pharmacovigilance medical writing : a good practice guide / Justina Orleans-Lindsay.

Includes bibliographical references and index.

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.

Print version record and CIP data provided by publisher.