Critical Compliance with ICH GCP - Webinar By ComplianceOnline (Clinical Training)
Venue: Online Event
|Event Date/Time: May 27, 2011||End Date/Time: May 27, 2011|
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of the ICH GCP Guideline (E6) is to provide a unified standard for the EU, Japan and the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions and therefore represents a gold standard for compliance for running clinical trials.
Areas Covered in the Seminar:
- What are the top FDA and EMA concerns in a GCP Inspection?
- What are the key requirements and principles of ICH GCP E6 for compliance?
- How to use ICH E6 to set up GCP quality systems for a specific clinical trial?
- How to use the E6 Essential Documents section to prevent critical recordkeeping errors?
- What are the most common violations found by - FDA and EMA inspectors at clinical sites?
- What are the most common violations found by -FDA and EMA inspectors at clinical trial sponsors?
- How to develop written procedures for "each stage of data handling"?
- What new concerns do FDA and FDA have with the conduct of clinical trials?
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