Webinars >>Clinical Trial
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Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?
Timely and adequate reporting of adverse events to FDA is the primary responsibility of the sponsors of INDs. FDA rules define the agency’s current expectations of sponsors, investigators, IRBs, and other personnel responsible for reporting safety related information while conducting clinical trials with a new investigational product or a generic drug. Also, the bioavailability and bioequivalence (BA/BE) studies (studies done for generic drugs) are subject to these IND safety reporting rules. The rules also require a safety database and trends data on adverse events to be submitted at least annually. There are stricter requirements for sponsors and investigators for evaluating a given adverse event before reporting it to the FDA and/or the IRB. Several definitions in the regulations have been revised recently and rules have been harmonized with internationally acceptable practices for safety reporting in clinical trials. The new requirements were inserted into the regulations to allow FDA the authority to enforce the same. Sponsor, investigators and all relevant personnel are supposed to be compliant with these rules or face penalties for non-compliance. Why should you attend:
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:
Who will benefit:
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com
