GCP’s and More: How to run a compliant clinical trial.
Website https://www.demystifiedsolutions.com/trainingDetails/GCP%E2%80%99s-and-More-How-to-run-a-compliant-c |
Deadline: April 24, 2017 | Date: April 24, 2017
Updated: 2017-03-09 20:13:33 (GMT+9)
Call For Papers - CFPThis 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 ICH, Part 812 or Part 312, and 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.Why Should You AttendAn inefficient, non-compliant clinical study can be a financial disaster for the company and may precipitate the demise of a product or even a company.If you have responsibly for establishing and/or managing a clinical trial, you must be aware of the pitfalls and be able to plan to prevent common problems. Areas Covered in this WebinarRegulations and guidance for clinical trial.Key elements of a clinical trailStaffing for successCommon problemsLearning ObjectivesCommon problems in GCP compliancePlanning a study to avoid non complianceEstablishing a clinical plan to launch, conduct, and finish a trialOverall management of the trialThe role of audits of the clinical programWhat to do when you discover non-compliance with GCPWho Will Benefit- Managers or supervisors of clinical departments in the drug/device industry- Mangers of CRO’s- Clinical Trials Coordinators at major medical research facilities.- Clinical Research Professionals desiring to climb the career ladder.For More Info, Please Click below URL:https://www.demystifiedsolutions.com/trainingDetails/GCP%E2%80%99s-and-More-How-to-run-a-compliant-clinical-trial-DEMY050153
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