Dec. 4 and Dec. 6: CReSS Workshop – Understanding the FDA Framework for the World of Investigational New Drugs (IDE) and Devices (IDE)
Please register for one of the following sessions:
Wednesday, Dec. 4, 2019, from 9 am – 10:30 am; MMEC 11‐101/102
Friday, Dec. 6, 2019, from 2:30 – 4 pm; MMEC 11‐101/102
Registration required: https://training.vcu.edu/manage/class/update/idCall3.asp?ID=17440
Presenter: Elizabeth Collins, MA, CCRP; FDA Regulatory Program Manager, OVPRI & Translational Workforce Development Working Group
Target audience: clinical research professionals including coordinators, regulatory specialists, research administrators, research nurses, and principal investigators with special emphasis on those involving faculty held IND‐IDE studies.
Learning objectives: After completing this workshop, the learner will be able to:
- define the FDA’s involvement with IND and IDE applications.
- identify the similarities and differences in the roles and responsibilities of an IND/IDE Sponsor,
Investigator, and Sponsor‐Investigator.
- know what resources are available for those participating in faculty held IND/IDE studies at VCU.
This workshop is part of the Clinical Research Skills Series (CReSS), coordinated by The Wright Center for Clinical and Translational Research. The purpose of CReSS is to provide the clinical research professional with skills and knowledge for the conduct of clinical research according to best practices. Thank you to Massey Cancer Center and the School of Medicine for their contributions to CReSS.