Adverse Drug Events – Reporting & Regulatory Requirements

Who Should Attend

This two-day course is designed for those involved with Clinical Research, Safety Surveillance, Regulatory Affairs, Clinical Trials, Medical Affairs and QA/QC issues.  It will also benefit Audit personnel and those in management who require a full understanding of international regulations regarding monitoring and reporting adverse events.



Learning Objectives

During this two day course you will learn about:

• Adverse Event (AE) Terminology
• Role & responsibilities of Pharma and the Regulatory Agency in AE reporting 
• Pre & Post-marketing AE reporting requirements worldwide
• Product Safety Update Reports
• Pharmacovigilance
• Safety issues
• Coding

Course Description

This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMEA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues. 

Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail.  Participants will be provided with templates for reporting requirements in each region covered.

Multiple exercises are included to reinforce the lecture material.  Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.