Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?
Date: April 2, 2025
Duration: 60 Minutes
Time: 12 PM EST
If your company or organization is involved in clinical trials, if you are a clinical site or safety monitoring/pharmacovigilance organization, if you are with an IRB overseeing clinical trials, or if you are not sure of your compliance status with the current regulations, you can get valuable tips and training in less than an hour. This seminar will discuss the current requirements, differences from the older requirements, and tips to not only to be compliant but processes to document how you address safety events in your clinical trials.
Areas Covered in the Session:
- Current regulatory requirements.
- Grades of adverse events and metered reporting requirements
- Role of clinical investigators and sponsors.
- What SOPs are needed for adverse event reporting
- Training requirements for personnel
- Good documentation practices for safety monitoring
Who will benefit:
- Safety reporting professionals
- QA/QC/Compliance/Regulatory affairs professionals
- Clinical trial professionals (e.g., CRAs, coordinators, nurses, pharmacists)
- Investigators participating in clinical trials
- Sponsors and investigator-sponsors of clinical trials
- Pharmacovigilance professionals
- Clinical trial specialists
- Project Managers
- People investing in FDA-regulated product development projects
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
