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33683 Conferences

How to Set up Data Monitoring Committees (DMCs / DSMBs) and what is effect on the Drug Development Process - Clinical Compliance Webinar By ComplianceOnline

Added by Referral on 2010-11-18

Conference Dates:

Start Date Start Date: 2010-12-14
Last Date Last Day: 2010-12-14

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This Data Monitoring Committees (DMC) webinar will guide you through the essential elements of data monitoring committees and how to set up for it successfully.

Areas Covered in the Seminar:

The historical background of why Data and Safety monitoring is essential.
The purpose of the Data and Safety monitoring plan.
The Regulatory requirements for safety monitoring.
Studies requiring a formal Safety Monitoring Committees.
What does the "Charter" of a DMC compose of?
What is the composition and function of a DMC?
What types of studies "require" a DMC?
Conflict of interest and the DMC.

Who Will Benefit:

This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
Principal Investigators / Sub-investigators.
Clinical Research Scientists (PKs, Biostatisticians,)
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting staff
QA / QC auditors and staff.
Clinical Research Data managers
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