This training course is designed to give all Health care workers involved in the supply of medicines an introduction to the fundamentals of product safety and regulatory compliance. The interactive eLearning course on Drug safety will comprise of ;
- Brief History of PharmacoVigilance and drug safety.
- Differences between adverse event reporting in the clinical vs. post-marketing settings
- How adverse events are assessed and reported
- Relationship testing (causality)
- Adverse event reporting formats
- Periodic reporting
and will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Credits: 6 CPD / CME
No. of Hours: 6 hrs
Learning Objectives:
By the end of the course you should have an understanding of regulatory requirements for drug safety, and knowledge of how to collect, assess, report and analyze adverse events.
Who Should Enroll:
Almost everyone involved in drug development and marketing needs to know the basics of FDA’s regulations regarding drug safety. Staff who will benefit include:
- Drug safety and pharmacovigilance
- Regulatory affairs
- Clinical development
- Executives (including C-Level) with any legal responsibility for drug safety