Investigator Reporting Responsibilities - OHRP

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