Get a complete understanding of GCP through a comprehensive analysis of GCP official text - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.
Why Should You Attend:
When conducting a Clinical Trial, GCP is the only recognized code of practice and needs to be followed meticulously. Following patient enrollment, knowledge of GCP is taken for granted by auditors and inspectors alike. Study Sponsors, include GCP training as part of investigator meetings, prestudy and initiation visits and their own employee training programs. A number of third party organizations offer relevant seminars. Training certificates are being issued to prove GCP competency. Inspectors review vigorously sponsor and site documentation to ensure adequate training.
Areas Covered in the Seminar:
- Sponsor responsibilities & tasks when running clinical trials (incl. CRA responsibilities).
- Investigator responsibilities & tasks when running clinical trials.
- Exploring the structure of the GCP handbook.
- Importance of Good Clinical Practice.
- Essential documents in Clinical trials.
- Definition of Adverse and Serious adverse events.
- ICH guidelines on the Informed consent process.
- How inspectors use the handbook .
- Definition of ranking of audit findings: minor-major-critical.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Research Facilities, Pharmaceutical & Biotechnology industry and CROs conducting Clinical Trials including:
- Investigators, site coordinators and subinvestigators
- Clinical Research Associates
- Clinical Operations Staff
- Managers in Clinical Development and Project Leaders
- Regulatory Compliance Associates and Managers
- Quality Assurance Managers and auditors
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