COMPLIACNE TRAININGS 2014 - Webinar On - Good Documentation Practices for Clinical Trials

Website https://www.compliancetrainings.com | Edit Freely

Category Compliance Trainings, Medical Device, Regulatory Affairs, FDA, Pharmaceuticals, online training, Healthcare, Regulatory Compliance, GCPs, Clinical Investigators (CI), Institutional Review Boards (IRBs), CROs, ICH-GCP, ISO 14155, GCP, SOPs

Deadline: February 04, 2014 | Date: February 04, 2014

Venue/Country: Online, Canada, Canada

Updated: 2013-12-26 15:23:56 (GMT+9)

Call For Papers - CFP

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