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Investigator Reporting Responsibilities - OHRP
Presented By Netzealous LLC DBA - Compliance4All
Friday, May 18th at 10:00am PST
Online sale ends: 05/18/18 at 9:00am PST
Online
Fremont, CA 94539
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Description
Overview: The webinar will also discuss how to make determinations of whether an adverse event is probably related, possibly related, or possibly/probably not related to a drug or device. Why should you Attend: Are you being cited for failure to report safety information, changes to the research plan, or protocol deviations/violations or noncompliance to the sponsor or the IRB? Areas Covered in the Session: FDA Regulations Overview of recent changes in regulatory framework GCP R2 Guidelines FDA guidance on electronic source documentation FDA BIMO Program Quality Management of Data Enhancing Excellence in conduct of Clinical Trials Who Will Benefit: Clinical Research Investigators Research Nurses Research Managers Clinical Research Associates (CRAs) Clinical Research Coordinators Compliance Officers Speaker Profile: George Gasparis has over 35 years of experience in the administration or conduct of human subjects research. He worked at the Office for Human Research Protections (OHRP) for seven years and served as the Director, Division of Assurances and Quality Improvement from 2000-03, where he led the development of the OHRP QI Program and electronic submission of the Federalwide Assurance (FWA). 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 Additional Information
http://www.compliance4all.com/control/w_product/~product_id=501856LIVE?channel=purplepass_May_2018_SEO
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Presented By
10:00am to 11:00am
General Admission: $150.00
50 18004479407 UPCOMING EVENTS
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