Investigator Reporting Responsibilities – OHRP

Start Date : May 18, 2018
End Date : May 18, 2018
Time : 10:00 am to11:00 am

Phone : 18004479407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

Website

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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