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.
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