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Genomics and Regulation

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.

Course Description:

The fundamentals of genomics testing will be discussed along with the FDA and FDA guidelines on the incorporation of data from genomic tests. Key objectives include:

  • Define pharmacogenomics and associated terms (i.e., genomics, personalized or precision medicine, genotype, genomic biomarker, and pharmacogenetics)
  • Understand different types of genetic testing required and regulatory pathways to introduce a new biological product onto the market
  • Understand the regulatory framework for products developed based on biomarker testing

Course Topics:

  1. Genetic testing:
    • Different types of IVD Testing
    • Direct-to-Consumer Testing (DCT)
    • DCT Genetic Testing
  2. Regulatory Pathway(s)
    • Carrier Screening Tests – Exempt from FDA premarket review
    • Genetic Health Risk (GHR) Tests – Requires FDA Clearance
    • Cancer Predisposition Test – Subject to premarket review & clearance
    • Pharmacogenetic Tests – Requires premarket review & clearance
  3. Guidance for Biomarkers (US) in the use of drug development
    • FDA Guidance for Biomarkers in the US
    • Guidance for Biomarkers/PGx and PGtData (EU)
    • CH E15 reflects EU Priority re: Confidentiality and Privacy
  4. Regulatory perspective on Biomarkers and companion diagnostics (CoDx)
    • Biomarker based Clinical Trial designs
    • Biomarkers vs. CoDx
    • Biomarkers as CoDx: In Vitro Companion Diagnostic
  5. The translational potential of complex disease genomics has significant implications for the health care system


Nancy Smerkanich, DRSc, MS, is an Assistant Professor in the Department of Regulatory and Quality Sciences, School of Pharmacy at USC. Dr. Smerkanich holds a Doctorate and master’s degree in Regulatory Science from USC and a Bachelor of Science Degree in Microbiology and a Bachelor of Arts in Russian from the University of Connecticut. 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 courses related to drug development and clinical trials, she provides 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 varied 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).


This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research 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: Intermediate/Advanced

Learner Disclosures:

  • Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
  • Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
  • Awarding Contact Hours: To obtain contact hours participants must
    • Review the entire activity
    • Pass the quiz with 100% of questions answered correctly
    • Complete the evaluation at the end
    • Certificates will be distributed at the end of the evaluation.
  • Enduring Materials Dates:
    • Start Date: 06/17/2022
    • Expiration Date: 06/16/2025

Need Help with Registration? Please contact us at or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.

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