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ICH-GCP Update - An Auditor's Perspective

ICH-GCP Update - An Auditor's Perspective

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Who should attend?

This course is designed for those with experience in clinical research requiring information on how to prepare for GCP inspections and for those seeking to update their knowledge on the changes to the ICH-GCP Guideline E6 R2. It is aimed at Clinical Research Assistants/Coordinators, Clinical Trial/Project Managers, Clinical Research Physicians, Study Data Managers, Monitors, those working in Clinical Quality and Compliance, and will also be of interest to those in related functions (Clinical Science, Drug Supply, Drug Safety, Regulatory).

Details

The course offers a thorough update of the current understanding and interpretation of Good Clinical Practice and practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites. With this course you will:

- Refresh knowledge of ICH-GCP, particularly from the Sponsor perspective including changes to ICH-GCP E6 R2
- Become familiar and discuss current "hot topics" in the Clinical Development environment
- Learn practical steps in preparing for Sponsor and Investigator site inspections
- Participate in interactive workshop exercises to improve course retention

Topics

- Overview of the history of GCP and the implementation of ICH-GCP
- Review of key elements of ICH-GCP, particularly related to Investigator / Sponsor responsibilities
- Changes to the ICH-GCP E6 R2 Guideline
- Impact of these changes on the conduct of Clinical Trials
- Inspection-Readiness: how to prepare for Sponsor / Site inspections
- Current "hot topics" in the area of Clinical Research, including: e-source documents, remote and risk-based monitoring

Prices

Early Bird Fee: CHF 855.00+ 7.7% VAT (valid until: 10.08.2018) Regular Fee: CHF 950.00 + 7.7% VAT (valid after: 10.08.2018) Registration fees include: Course documentation, refreshments, lunch and a course participation certificate. Group discounts available, for more information please contact: training@ctcresourcing.com

Contact

Tamara Kohler
tamara.kohler@ctcresourcing.com

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