Drug Safety & Adverse Event Reporting

<!--td {border: 1px solid #ccc;}br {mso-data-placement:same-cell;}-->This course explains the regulatory requirements in the clinical trial and post-marketing environments, while also describing the international drug safety monitoring efforts. Topics in this course include: History, Pre-clinical Safety Data, Sponsor Responsibilities, and Postmarketing Reports. After completing this course, learners will be able to recognize terminology associated with drug safety monitoring during clinical trials, identify sponsor’s responsibilities regarding safety reporting, and recognize the importance of drug safety and adverse event reporting.

After this course learners will be able to recognize key historical events that led to the current system of drug safety monitoring, identify the role of pre-clinical testing required as part of the drug approval process. recognize terminology associated with drug safety monitoring during clinical trials. identify sponsor’s responsibilities regarding safety reporting. recognize the importance of drug safety and adverse event reporting (inclusive of post-marketing and post-marketing reports).