Detail E-Book
Pharmacovigilance Medical Writing
Pengarang: Justina Orleans
Edisi: -
ISBN/ISSN: 978-1-119-96726-2
Penerbit: Wiley Blackwell
Tahun Terbit: 2012
Tempat Terbit: Chichester, West Sussex
Judul Seri: Pharmacovigilance Medical Writing
Bahasa: English
No. Panggil: PHA
GMD: Electronic Resource
Catatan
Pharmacovigilance is an activity concerned with monitoring, assessing, and supervising drug safety to identify and prevent potential adverse effects that may occur during medication use. The book Pharmacovigilance Medical Writing: A Good Practice Guide by Justina Orleans-Lindsay discusses the preparation of drug safety documents as an important part of the drug development and marketing process. The topics include the preparation of safety reports for clinical trials, supporting documents for marketing authorization applications, and the monitoring of drug safety after products are marketed. Several documents are discussed, including the Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Risk Management Plan (RMP), and Benefit-Risk Evaluation Report. Preparing these documents requires accurate data collection, safety information analysis, collaboration among different departments, and compliance with regulatory guidelines and requirements. Through these discussions, readers gain an understanding of the importance of systematic and high-quality documentation in supporting drug safety monitoring, identifying potential risks, and ensuring patient safety.
Keywords: Pharmacovigilance, Drug Safety, Medical Writing, Adverse Drug Reactions, Drug Monitoring.
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