TY - BOOK AU - Orleans-Lindsay,Justina TI - Pharmacovigilance medical writing: a good practice guide SN - 9781118301913 AV - RM301.25 U1 - 615/.4 23 PY - 2012/// CY - Chichester, West Sussex, UK PB - Wiley Blackwell KW - Pharmacoepidemiology KW - Writing KW - Drug monitoring KW - Communication in medicine KW - Methodology KW - Drug Monitoring KW - Health Communication KW - methods KW - Pharmaceutical Preparations KW - adverse effects KW - Product Surveillance, Postmarketing KW - MEDICAL KW - Pharmacy KW - bisacsh KW - Electronic books N1 - 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 UR - http://onlinelibrary.wiley.com/book/10.1002/9781118301906 ER -