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FDA Requirements for Sponsor to Report Fraud

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description

This course will present the content and discuss the impact of the new FDA draft regulatory amendment to 21CFR312.56 & 21CFR812.46 regarding the sponsor responsibility for review of ongoing investigations and monitoring investigations, respectively. The web seminar will present events leading up to the draft, and include a discussion of what reporting a suspicion of fraud vs. a confirmed case of fraud means, as well as discussion of what is not in the rule that was anticipated.

Learning Objectives

  • Recognize the history of the draft regulation and events leading to the release
  • Review the content of the draft related to 21CFR312.56 & 21CFR812.46
  • Examine implications on stakeholder activities

Who Should Attend

  • Sponsors/CROs
  • Project Mangers
  • Medical Writing Professionals
  • Regulatory Professionals
  • Quality Assurance Personnel
  • Data Management Professionals 

Instructor

Jeanne Morris, B.S., MT (ASCP)

Click here for complete trainer biographies 

Registration Fees

$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-10-028-L01-P. Released: 8/10.

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

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On-Demand GCP Refresher Training 

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GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

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Blended Curriculum Path for the CRA, CRC, and Project Manager

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10-Week CRA & CRC Beginner Program  

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)