Aggregate reporting in the US
Let us guide you through the Aggregate reporting in the US topic and get the necessary knowledge and skills to do it right
- 150 min workload
The analysis of the safety profile of any medicine should weight up the consequences of a given adverse drug reaction to individual patients exposed to the medicine, as well as the impact on the community.
This course intends to bring you :
- Information relating to types of aggregate reporting in pharmacovigilance
- Knowledge of US aggregate reporting requirements
What will you learn
At the end of the course, you will have :
- Knowledge of aggregate reports, including Periodic Adverse Drug Experience Reports (PADERs) and Periodic Adverse Experience Reports (PAERs), as well as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs) as applicable to FDA requirements
- Knowledge of the US Regulatory Framework
- Videorecorded lectures
- Lecture slides and supplemental reading materials
- Continuous individual progress assessments
- Final exam quiz
- Certificate of Completion for the course Aggregate reporting in the US issued by the Am2P partners
Within which Am2P Certificate
Who made this course
ISoP's North American chapter
How does it work
- Sign up with minimal personal information, or sign in if you already have an account
- Register to this course immediately and get access for 12 months
- Follow the different course activities at your own pace
- At the end of the course, you will pass a final examination and, upon success, you will get a Certificate of Completion for the course Aggregate reporting in the US!
- In case of failure, you can review course activities and retake the final examination quizzes, as long as your 12 months active period is on!
Register now and get access to the course for 12 months!
|Individual||250 € / 270 $|
|Groups||Please contact us (price discounts based on group size)|