gcp-training certificate -...

GCP-Training Certificate has attended the training course "The Conduct of Clinical Studies according to ICH and the applicable EU regulations" on 29.01.2016 The training course lasted 8 hours and consists of the following 8 training modules: 1. Development of Drugs & Medical Devices 2. Principles of Biometry 3. Declaration of Helsinki & GCP Guidelines 4. Study Documents, Ethics Committees & Quality Requirements 5. Responsibilities of Investigators Part 1 6. Responsibilities of Investigators Part 2, Responsibilities of Sponsors, Audits 7. Inspections and Reporting of Safety Related Events 8. Current Legislations & Regulations on Clinical Trials in Europe The qualification of the attendee has been tested by a 8 multiple-choice test which covers 120 randomised assigned questions. The trainee has answered at least 80% of the questions correctly. The training course has been accredited by the Medical Association of Bremen. 8 Continuing Medical Education (CME) points have been assigned. The course number is *2760402016002070008* .

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GCP-TrainingCertificate

has attended the training course "The Conduct of Clinical

Studies according to ICH and the applicable EU regulations" on

29.01.2016 The training course lasted 8 hours and consists of the following 8 training modules:

1. Development of Drugs & Medical Devices2. Principles of Biometry3. Declaration of Helsinki & GCP Guidelines4. Study Documents, Ethics Committees & Quality Requirements5. Responsibilities of Investigators Part 16. Responsibilities of Investigators Part 2, Responsibilities of Sponsors, Audits7. Inspections and Reporting of Safety Related Events8. Current Legislations & Regulations on Clinical Trials in Europe

The qualification of the attendee has been tested by a 8 multiple-choice test which covers120 randomised assigned questions. The trainee has answered at least 80% of the questionscorrectly. The training course has been accredited by the Medical Association of Bremen.8 Continuing Medical Education (CME) points have been assigned. The course numberis *2760402016002070008* .

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