This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.
In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.
The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.
Join the Analyst Academy Pro and get a job as a job as a research analyst or simply fast-track your career in asset management.
Become an FSSC 22000 v6 Lead Auditor with our CQI and IRCA certified course. Gain the skills to lead food safety management audits and elevate your career. Enroll today!
A Practical Introduction to Conflict Management for Project Managers
You can't make more time... But you can make better use of the time you have. Let top expert Mike Clayton show you how.
Everything a Project Manager Needs to Know to Maximize the Value of One-on-One Time