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:
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
Clinical Research Associates (CRAs)
Clinical Research Coordinators
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
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