161 Mission Falls Lane, Suite 216,

Fremont,

CA,

US,

ZIP: 94539

Phone: 18004479407

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: [email protected]