How strong is your knowledge of GCP? A presentation on official GCP guidelines for compliant investi (Clinical Training)

Venue: Online Event

Location: Online Event,Palo Alto, California, United States

Event Date/Time: Oct 18, 2011 End Date/Time: Oct 18, 2011
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Description

This webinar will attempt to fill this gap by analyzing clinical trial conduct via the official GCP handbook itself. It will help you gain a solid knowledge of the rules governing clinical trials. Attendees will get accustomed to the structure and content of the actual guidelines, by familiarizing themselves 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.

Venue

Online Event
2600 E. Bayshore Road
California
United States
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