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.
It is addressed to those who wish to build a solid knowledge of the rules governing clinical trials, those that wish to be able to start developing their own judgment on what is critically important and what`s not. This can only be done when one gets accustomed to the structure and content of the actual guidelines, when one becomes familiar with the actual wording therein.
The version of the ICH GCP guideline that will be analyzed is ICH/135/95, July 2002, from the European Medicines Agency NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.
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
Note: Use this promocode(
117660) for 10% discount.
