Webinar On Good Clinical Practices (GCP)

Event Details

Time: June 22, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: May 22, 2015

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Event Description

Description :

This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including 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.

GCP requirements including documentation requirements (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 :

Laws and Regulations

Definitions

Clinical Trials and Requirements

Regulatory Requirements for INDs and IDEs.

Duties and Responsibilities for Clinical Investigators (CI), Institutional Review Boards (IRBs), Sponsors and Monitors, and 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

Research & Development