This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.
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.
Everything a Project Manager Needs to Know to Maximize the Value of One-on-One Time
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.
Are you already on your way in your Facilities Management career? Are you looking to advance into the next professional level in Facilities Management? This Level 4 Certificate in Facilities Management course is delivered via our well-established Virtual Learning Environment. All course content is fully available via the screen or for download and can be accessed anytime, anywhere so you can plan your own schedule.