Regulatory Aspects of Cell Therapy and Regenerative Medicine

The rapidly evolving field of regenerative medicine, marked by advancements in cell and gene therapies, has prompted regulatory agencies to work diligently to adapt to these innovations. This course offers an overview of regenerative medicine therapies and the necessary FDA’s oversight.

Learner Objectives:

1.     Define cell, gene, and regenerative medicine therapy.

2.     Distinguish the difference between drugs and biologics.

3.     Describe FDA’s role and responsibilities in regulating regenerative medicine products.

4.     Identify the challenges in developing cell and gene therapies.

5.     Explore the advances that have been made within the regenerative medicine field.

Course Topics:

1. Overview of Regenerative Medicine Products
2. Small Molecule (Drug) vs Large Molecule (Biologics)
3. Regulations in Regenerative Medicine
4. Center for Biologics Evaluation and Research (CBER)
5. Office of Therapeutic Products (OTP)
6. FDA’s Role in Regulating Regenerative Medicine
7. Advancements in Regenerative Medicine Therapy (RMT)
8. Regenerative Medicine Advanced Therapy (RMAT) Designation
9. Regenerative Medicine Globally

Course Speaker:

Dr. Nancy Pire-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).

Learner Level: Intermediate/ Advanced

Audience:

This symposium is designed for Clinical Research Coordinators, Clinical Research Nurses, 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 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: 05/01/2024
• Expiration Date: 05/01/2027

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

Program Information:

This is the first course in a five (5) course program, Innovations in Regenerative Medicine Products.