This web seminar presents an overview of FDA’s Adverse Event Reporting Systems for Drugs and Medical Devices. Adverse Event Reporting for Investigational Drugs/Medical Devices and post-approval Adverse Event reporting will be covered. Attendees will receive information about FDA Adverse Event regulations and how to interpret and comply with the various regulations.
This is a must attend webinar for those personnel that require an understanding of the regulations governing FDA’s Adverse Event Reporting for Drugs and Medical Devices.
Areas Covered in the Session :
FDA Adverse Event Reporting Systems
Investigational Adverse Event Reporting
Marketed Product Adverse Event Reporting
Adverse Reporting Definitions
Safety Reports and Unexpected Adverse Device Effects
Who Will Benefit:
Regulatory Affairs Personnel
Clinical Research Associates
Personnel who require a general understanding of the FDA’s Drug and Medical Device Adverse Event Reporting requirements.
Single Live : For One Participant
Corporate Live : For Max. 10 Participants
Single REC : For One Participant - Unlimited Access for 6 Months
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