Why are we Seeing More Independent Data Safety Monitoring
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Website http://www.compliance4all.com/control/w_product/~product_id=501591LIVE?channel=ourglocal_Dec_2017_SE |
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Category Data Monitoring Committee, contract research organization, electronic data capture, data monitoring committee guidance, Drug-Device Development
Deadline: December 04, 2017 | Date: December 05, 2017
Venue/Country: Fremont, U.S.A
Updated: 2017-10-31 15:45:16 (GMT+9)
Call For Papers - CFP
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$150.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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