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Fast Facts

GCP/ICH Obligations of Sponsors, Monitors, and Investigators- barriers and solution

Webinar: 10:00 AM PDT | 01:00 PM EDT
May 25,2010 - May 25,2010
Online Event, Palo Alto, United States
 

Highlights

In this clinical training you will learn the clinical research team roles, most common activities and how to link responsibilities to these activities and attain GCP compliance as per ICH guidelines.

Why Should You Attend :

Well controlled and well conducted clinical trials are important to both sponsors and investigator sites. Compliance with Good Clinical Practice and ICH guidelines will ensure quality data, speeds up the review process for new drugs and decreases the costs to sponsors. This webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines.


Areas Covered in the Seminar :


- Background of ICH-GCP.
- Importance of Good Clinical Practice.
- Discuss The Clinical Research Team: Roles & Responsibilities.
- Principles of GCP.
- Activities that are common to most trials.
- Linking responsibility to these activities.
- Utilizing ICH guidelines for GCP compliance.
-Using the FDA Compliance Program results to identify key issues in managing and conducting clinical trials.











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Event Profile

Theme: Webinar: 10:00 AM PDT | 01:00 PM EDT
Sponsors: ComplianceOnline
Speakers: Sandy Rizk Soliman
Attendees: Managers in Clinical Development and Project Leaders,Quality Assurance Managers and auditors,Clinical Research Associates,Clinical Operations Staff,Regulatory Compliance Associates and Managers

Contact Details

Contact person: Admin
Event website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701668?channel=gtm
Phone: 1-650-620-3915
Fax: +1-650-963-2556

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