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Why are we Seeing More Independent Data Safety Monitoring

Event Details

Why are we Seeing More Independent Data Safety Monitoring

Time: December 5, 2017 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: webinar
Organized By: Netzealous LLC DBA - Compliance4All
Latest Activity: Oct 30, 2017

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Event Description

Overview:
It is important to see what the FDA regulations and the ICH GCP recommendations are in regard to DMC's. Most importantly, when does an adverse event (AE) or string of AE's lead to changes in a study protocol or even discontinuation of a study.

Why should you Attend:
With the increasing requirements for a DMC oversight it behooves all involved to know the set-up and function of these committees. Forewarned is forearmed.

Areas Covered in the Session:
Studies requiring a formal Safety Monitoring Committee
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?

Who Will Benefit:
Clinical Research Scientists
Research Managers
Safety Nurses
Clinical Research Associates (CRAs)

Speaker Profile:
Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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