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Regulatory Considerations

1 credit


Full course description

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.


Challenges to federal regulators in evaluating new and emerging therapies including gene therapy, cell therapy, tissue engineering, innovative medical devices, and innovative information technology (IIT) will be discussed.

Course Topics:

  1. FDA Safety and Innovation Act (FDASIA, 2012)
  2. FDA Reauthorization Act (FDARA, 2017)
  3. 21st Century Cures Act (2016) – Regenerative Medicine Advanced Therapy (RMAT) Designation
  4. CDER Emerging Technology Team
  5. CBER Office of Tissues and Advanced Therapies (OTAT)
  6. Critical Path Institute
  7. New precedent
  8. Guidance
  9. Regulatory Pathways and Science
    • Regenerative Medicine Advanced Therapy (RMAT)
    • Breakthrough Therapy Designation
  10. FDA Strategic Plan for Regulatory Science
  11. Clinical Outcome Assessment (COA) Qualification Program
  12. Biomarker Development
    • Drug Development Tools (DDT) Qualification Programs
    • Biomarker Qualification Program
  13. Biomarker Development Pathway Integration
    • Scientific Community Consensus
    • Drug Approval Process
    • Biomarker Qualification Program
  14. FDA Guidance for Industry
    • Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
    • Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization
    • Recommendation for Microbial Vectors used for Gene Therapy
    • Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271
    • Preclinical Assessment of Investigational Cellular and Gene Therapy Products
  15. GCPs Additional Challenges


Nancy Smerkanich, DRScMS, is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California (USC).Dr. Smerkanich received her faculty appointment after successfully completing her Doctoral Dissertation on “Benefits Risk Frameworks –Implementation in Industry” in 2015.  In addition to teaching in courses related to drug development and clinical trials, she continues to provide regulatory guidance to industry peers. Nancy brings many years of practical regulatory knowledge and experience to academia where she participated in all regulatory aspects of product development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Known for her dedication to education and mentoring across industry, Nancy continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as the Drug Information Association (DIA) and The Organization for Professionals in Regulatory Affairs (TOPRA).With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Prior to joining Octagon, Dr. Smerkanich held various Regulatory Affairs positions within industry, including nine years at Merck and seven years as an independent consultant. Dr. Smerkanich holds a Doctorate and Master’s degree in Regulatory Science from USC and Bachelor of Science Degree in Microbiology and a Bachelor of Arts in Russian from the University of Connecticut.


This course 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 challenges.

Learner Level: Advanced

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 or 404-727-9208.

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

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