Investigational Product Accountability Best Practices

Oct 6, 2018, 18:22 PM
Course ID : 181
Acronym : CTLSPA
Unlock best practices for investigational product accountability with Barnett International's course. Take action now!

Course Description

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.

Learning Objectives

  • 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

Who Should Attend

  • Investigators
  • Coordinators
  • Pharmacists
  • Clinical Research Associates
  • Project Managers

Instructor

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Click here for complete trainer biographies

Registration Fees

$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 

Accreditation Information

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#: 0778-0000-22-026-L04-P. Released: 8/22. 

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

Series :
  • Clinical Trials & Translational Medicine
Topics :
  • Clinical Research
  • Project Management
  • Regulatory Compliance
Job Functions :
  • Clinical Operations & Trial Management
  • Clinical Quality Assurance
  • Clinical Research Associate
  • Clinical Research Investigator
  • Project Manager
  • Study Site Compliance
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