原文始发于微信公众号(化学音乐文化):S3C4:Pharmacovigilance
JanFourman,PhD, EdD,MBA, MSRA
扫描左侧二维码,获取视频课;扫描右侧二维码,获取音频课 Part 1 – Drug Pharmacovigilance Define and understand the goal of Pharmacovigilance Recognize the role of Pharmacovigilance in the drug development process Realize the importance of adverse event collection Become familiar with spontaneous and clinical trial adverse event reports Understand Regulatory reporting requirements and post-marketing surveillance Part 2 – Core Safety Information What is core safety information? What are core safety reporting languages? MedDRA ICD-10 What are FDA’s databases for core safety reporting? Part 3 – Counterfeit Reporting Impact Case Studies: Avastin Fentanyl How to report AEs from Counterfeiting Office of Drug Security, Integrity, and Recalls (ODSIR) Healthcare Professional’s Role Part 4 – Safety Collection in Clinical Trials Introduction Data Collection: Who What How When Follow-up Checklist
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