Webinar On Good Documentation Practices for Clinical Trials
To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.
The documentation requirements including a set of SOPs with key elements to be contained in the SOP will be discussed.
In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety.
Areas Covered in the Session:
• Statutes, Regulations and Definitions
• Regulatory Requirements for INDs and IDEs.
• Clinical Trials
• Clinical Investigators (CI)
• Institutional Review Boards (IRBs)
• Sponsors and Monitors
• Contract Research Organizations (CROs)
• ICH-GCP Guidelines
• ISO 14155
• List of SOPs and Adequate Documentation
• Key Elements in the SOPs
• Common GCP Deficiencies in EU and US
• Enforcement Actions
• Lessons Learned
Who Will Benefit:
• Clinical Affairs
• Regulatory Affairs
• Quality Assurance
• Senior Management
• Anyone Interested in the Topic
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