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Webinar On Good Documentation Practices for Clinical Trials

2/4/2014 12:00 PM - 1:00 PM

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

Address:5939 Candlebrook Ct,

Mississauga, ON L5V 2V5,


Customer Support : 416-915-4458

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