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Recorded Webinar
FDA Requirements for Good Clinical Practice’s and efficient and effective clinical trial
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This Webinar will discuss the basics of Good Clinical Practice, but go even more to address the requirements to run an efficient and effective clinical trial. Few companies can afford to have a clinical trial start and then face compliance issues, or even more seriously run an inefficient trial, and fail to achieve clinical endpoints, not because of a lack of efficacy, but because the data was confounded by poor management of the trial.
This “more” discussion will go beyond Part 812 or Part 312, but will also include a discussion of ICH E-6 Good Clinical Practice: Consolidated Guidance (FDA's official guidance related to GCP).
We will also discuss the management process for designing clinical trials, selecting investigators, developing a clinical study implementation plan, and effective monitoring.
The presentation will discuss:
- Common problems in GCP compliance
- Planning a study to avoid non compliance
- Establishing a clinical plan to launch, conduct, and finish a trial
- Overall management of the trial
- The role of audits of the clinical program
- What to do when you discover non-compliance with GCP
Who should attend
Anyone who is interested in learning more on FDA Requirements for GCP
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