One
of the top regulatory findings both in the U.S. and in global inspections is
related to investigational product (IP) accountability. In this web seminar, we
will discuss the common sources of error, recommend procedures and training
techniques, and evaluate the differences in investigational and
non-investigational products. Investigator and sponsor responsibilities will be
described, as well as “best practices” for implementation of those responsibilities.
- Describe IP accountability requirements and
regulatory considerations
- Discuss non-investigational
medicinal product and rescue medication management and documentation
- Define the responsibilities of the
research site in IP accountability
- Develop strategies for identifying
and solving IP accountability errors or deficiencies
- Investigators
- Coordinators
- Pharmacists
- Clinical Research Associates
- Project Managers
This course will be taught by one of the following instructors:
Nikki
Christison, B.S., C.C.R.A.
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
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.
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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-17-090-L01-P.
Released: 1/18.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
