The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

Researchers have been unlocking the potential of stem cells to treat a variety of medical conditions and diseases; however, guidance and regulations for the stem cell manufacturing industry remains complicated and open to interpretation. This course examines the regulation, oversight and logistics of human cells, tissues, and cellular and tissue-based product manufacturing and administration.

Topics:

1. Autologous stem cell treatments
   • Does the FDA have the authority to regulate autologous stem cell treatments?
   • Do you have to file an IND for an autologous stem cell study?
2. Categories of Stem Cells Recognized by the FDA
3. FDA Regulations:
   • “Highly processed”
   • Consideration as biologic products and licensing
4. Definition of Processing
5. Definition of Minimal Manipulation
6. Current Good Tissue Practice (cGTP)
7. Donor Eligibility
8. Managing Adverse Events During a Stem Cell Clinical Study:
   • Mandatory reporting under MedWatch
   • 21 CFR Part 1271
   • The “CAR-T Cell Effect” - FDA press release (August 30, 2017)
9. Combination Product

Speaker:

Michael Jamieson, DRSc, Associate Director of the Regulatory Science Programs, joined the faculty of the USC School of Pharmacy in 2011. Dr. Jamieson received his master's from the University of Southern California in 2008 and was in the first graduating class for the Doctorate of Regulatory Sciences in 2011.  Dr. Jamieson's research interests include the regulatory support of university based researchers and the commercialization of medical products developed at universities. His teaching focuses on global regulatory issues with an emphasis on Canada, Europe and South America.Dr. Jamieson has built an international reputation around his ability to develop innovative regulatory solutions which enable companies to get their products and facilities through the regulatory hurdles in a timely fashion.  In 1991 Dr. Jamieson founded Pharmacon Research Inc. with the original concept being to assist international companies in the development of integrated new product development programs for the North American market. In the fall of 2003, the company name was changed to InSource Innovations Inc. (Ottawa, Ontario, Canada).mjamieso@usc.edu .

Learner Level: Advanced

Audience:

This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 1.0 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the third course in a six (6) session program. To complete the entire program and earn a badge CLICK HERE.