Why are we Seeing More Independent Data Safety Monitoring
- Start Date:
- Tuesday, 5 December, 2017
- End Date:
- Tuesday, 5 December, 2017 11:30am
- Health & Nutrition
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 CommitteeWhat 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 ScientistsResearch ManagersSafety NursesClinical 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: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All