Pharmacovigilance medical writing : a good practice guide /

• Κύριος συγγραφέας: Orleans-Lindsay, Justina
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Chichester, West Sussex, UK : Wiley Blackwell, 2012.
• Θέματα: Pharmacoepidemiology.; Writing.; Drug monitoring.; Communication in medicine > Methodology.; Drug Monitoring.; Health Communication > methods.; Pharmaceutical Preparations > adverse effects.; Product Surveillance, Postmarketing.; MEDICAL > Pharmacy.; Electronic books.

Πίνακας περιεχομένων:

• 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.