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Webinar On - Good Documentation Practices for Clinical Trials
This Webinar is over| Date | Feb 4, 2014 |
| Time | 03:00 PM EDT |
| Cost | $249.00 |
|
Online
|
Scheduled On : Tuesday, February 4, 2014 at 13:00 Hrs
Description:
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
Description:
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
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