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FDA's Bioresearch Monitoring (BIMO) Program: New Guidance for Inspection of Sponsors, CROs, and Monitors December 2011

Dec 7, 2011
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Course Description 

The FDA recently released its much-anticipated Compliance Program Guidance Manual on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. This web seminar will review the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

VideoPreview 


Learning Objectives 

  • Review how new regulatory requirements are being incorporated into inspections
  • Discuss the new guidance and rules that support changes in inspection focus
  • Assess the FDA’s application of the guidance as reflected in regulatory communication
  • Examine steps for preparation of an inspection

Who Should Attend 

  • Professionals from Academia whose institutions or investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)
  • Clinical Quality Assurance Auditors
  • Clinical Quality and Compliance Professionals
  • Clinical Research Associates
  • Project Managers
  • Medical Monitors
  • Regulatory Affairs Professionals
  • Clinical Research Coordinators
  • Sponsor-Investigators
  • Sponsor and CRO Representatives

Instructor 

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies 

Course Length Time 

2 hours; 9:30 – 11:30 a.m. Eastern

Course Dates 

December 7, 2011

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 2 hours (0.2 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#: 0778-0000-11-074-L01-P. Released: 9/11. 

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

 

 

 

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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)