Webinar On - Good Documentation Practices for Clinical Trials

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
• R&D
• Consultants
• Contractors/Subcontractors
• Senior Management
• Anyone Interested in the Topic