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.
- 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)
- 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
The course will be led by one of the following
instructors:
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.