The Center for Professional Innovation & Education, Malvern, PA
12/13/07
Who Should AttendThis 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 adverse event reporting and regulations. Learning Objectives During this two day course you will learn about: -FDA’s role in the drug development process -The clinical research process -Pharmacovigilance -Adverse events (expected and unexpected) -Safety issues -Coding -Safety issues in investigational studies -Safety issues in the post-marketing era Course Description
This course will provide participants an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed. FDA/ICH roles in the drug safety process will be reviewed. The course will also discuss FDA law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues.
|