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Orleans-Lindsay, Justina.

Pharmacovigilance medical writing : a good practice guide / Justina Orleans-Lindsay. - Chichester, West Sussex, UK : Wiley Blackwell, 2012. - 1 online resource.

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.

ISBN: 9781118301913 1118301919 9781118302057 1118302052 9781118302064 1118302060 9781118301906 1118301900

LCCN: 2012002010

Subjects--Topical Terms:
Pharmacoepidemiology.
Writing.
Drug monitoring.
Communication in medicine--Methodology.
Pharmacoepidemiology.
Writing.
Drug Monitoring.
Health Communication--methods.
Pharmaceutical Preparations--adverse effects.
Product Surveillance, Postmarketing.
MEDICAL--Pharmacy.

Index Terms--Genre/Form:
Electronic books.

LC Class. No.: RM301.25

Dewey Class. No.: 615/.4

National Library of Medicine Call No.: QZ 42