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POST ID: 5243

Webinar On - Good Documentation Practices for Clinical Trials

Region: Canada
Location: Canada


This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices.

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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