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Site language : English - Français
Ref : 26776
Event :Investigator Reporting Responsibilities - OHRP

Date :Friday May 18th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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
http://www.compliance4all.com/control/w_product/~product_id=501856LIVE?channel=doctorama_May_2018_SEO

Further information

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Announcer

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 [...]

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Details

Investigator Reporting Responsibilities - OHRP Pharmacy - Bio-Technologies - Management
--
Everyone, Research Nurses Research Managers Clinical Research Associates Clinical Research Coordinators Compliance Officers
50 1 --
English

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