Tuesday, December 5 | 10:00 am - 11:30 am
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