Compliance 2014 - Webinar On - Good Documentation Practices for Clinical Trials

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