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. Regulatory agencies’ 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 preventive action plans are developed to
secure compliance. This web seminar will examine the trends in recent
regulatory communication and open discussion for review of acceptable versus
unacceptable responses.
- Review recent FDA, European Medicines Agency
(EMA), and Health Canada findings for Clinical Investigators (sites),
sponsors, and IRBs
- Determine areas of compliance
concentration for regulatory agencies
- 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
- Clinical Research Associates
- Project Managers
- Principal Investigators
- Clinical Research Coordinators
- IRB Administrators and Members
- Clinical Quality Assurance Auditors
- All other personnel responsible for
ensuring compliance with GCP regulations
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$735
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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com
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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-019-L01-P.
Released: 4/18.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.