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
- Clinical Research Associates
- Project Managers
Nikki Christison, B.S., C.C.R.A.
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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#: 0778-0000-15-023-L01-P. Released: 3/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.