Safety Reporting in Clinical Trials: Are you Ready for the New FDA Rules Effective from 28 March 201 (Clinical)
Venue: Online Event
|Event Date/Time: Jun 09, 2011||End Date/Time: Jun 09, 2011|
In late September last year, FDA announced several major revisions in its IND safety reporting requirements. These rules defined the agencyâ€™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.
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 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. Sponsors, investigators and all relevant personnel are supposed to be compliant from 28 March 2011.
If your company or organization is involved in clinical trials, if you are a clinical site or safety monitoring/pharmacovigilance organization, if you 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 new requirements, differences from the older requirements, and tips to not only be compliant but processes to document how you address safety events in your clinical trials. Topics covered include
What has changed from earlier?
How do these changes impact ongoing and recently completed clinical trials?
Best practices to implement new safety reporting processes
Do's and Don'ts of safety reporting
Areas Covered in the Seminar:
Current regulatory requirements.
Rationale for these changes.
Role of clinical investigators and sponsors.
Amending existing SOPs and/or creating new ones.
Training requirements for personnel.
Good documentation practices for safety monitoring.
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