Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada November 2017

Nov 1, 2017
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Course Description

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. The FDA’s recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventative action plans are developed to secure compliance. This web seminar will examine the trends in recent regulatory communication (warning, NIDPOE, NOOH letters and 483s) and open discussion for review of acceptable versus unacceptable responses.

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Learning Objectives

  • Review recent FDA findings for Clinical Investigators (sites), sponsors, and IRBs
  • Determine areas of compliance concentration for CBER, CDER, and CDRH
  • Discuss what factors may be helping drive the present approach and what it may mean for future compliance considerations
  • Examine best practices for responding to a regulatory communication (e.g., a 483)

Who Should Attend

  • Clinical Research Associates
  • Project Managers
  • Clinical Research Coordinators
  • Clinical Principal Investigators
  • IRB Administrators and Members
  • Clinical Quality Assurance Auditors
  • All other personnel responsible for ensuring compliance with GCP regulations

Instructor

The course will be led by one of the following instructors:

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.