Online PBC in Regulatory Affairs for Cell and Gene Therapy
Drexel University’s online Certificate in Regulatory Affairs for Cell and Gene Therapy trains leaders for this growing discipline and prepares you to bring new therapeutics to market. You'll learn how to manage everything from pre-clinical IND-enabling studies to product licensure, and into post-approval life cycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, ethics, CMC, and international market requirements for cell and gene regulatory affairs.
Regulatory affairs for cell and gene therapy (CGT) differs from regulatory affairs for pharmaceutical companies in several key aspects. While both areas involve navigating regulatory requirements and obtaining approvals, CGT presents unique challenges due to the innovative nature of these therapies. Here are some key differences:
Cell and gene therapies involve complex, personalized products that often require manipulation of a patient's own cells or genetic material. This complexity differs significantly from traditional pharmaceutical products, which are typically small molecules or biologics. The manufacturing, quality control, and characterization processes for CGT products are distinct and require specialized expertise.
The development pathway for CGT is often more iterative and dynamic compared to traditional pharmaceuticals. CGT products may undergo multiple modifications during the development process to optimize efficacy and safety. Regulatory affairs professionals working in CGT need to navigate this evolving landscape, including addressing changes in the manufacturing process and adjusting regulatory strategies accordingly.
Clinical Trial Design
Clinical trials for CGT products often involve smaller patient populations due to their personalized nature. Additionally, CGT trials may have unique endpoints and study designs tailored to assess the therapeutic efficacy of these treatments. Regulatory affairs professionals in CGT must have a deep understanding of the specific requirements for designing and conducting trials for these innovative therapies.
Regulatory authorities worldwide have recognized the need for tailored regulations to accommodate the unique aspects of CGT products. Many countries have established specific regulatory frameworks or expedited pathways to facilitate the development and approval of these therapies. Regulatory affairs professionals in CGT need to stay abreast of these evolving regulations and work closely with regulatory agencies to ensure compliance.
Safety and Risk Management
Due to the novel nature of CGT products, safety considerations and risk management play a crucial role in regulatory affairs. Assessing and mitigating potential risks associated with the use of genetically modified cells or vectors is a primary concern. Robust pharmacovigilance programs are necessary to monitor the long-term safety and efficacy of these therapies.
- 100% online
- Courses taught by industry experts in Drexel University’s School of Biomedical Sciences and Professional Studies within the College of Medicine
- Credits from the Regulatory Affairs for Cell and Gene Therapy Certificates are eligible to be shared with the MS in Biomedicine and Cell and Gene Therapy
- No application fee
What will I learn in Drexel University’s online PBC in Regulatory Affairs for Cell and Gene Therapy?
Upon completion of the online Certificate in Regulatory Affairs for Cell and Gene Therapy, you will:
- Develop divergent (e.g., generation of novel ideas, thinking out of the box, brainstorming) and convergent thinking (e.g., critical thinking, evaluation of ideas, quantitative and qualitative analysis, scientific reasoning) to generate novel and relevant ideas, strategies, approaches or products.
- Be able to assess your own ethical values and the social context of ethical problems, recognize ethical issues in a variety of settings, think about how different ethical perspectives might be applied to an ethical problem, and consider the consequences of alternative actions.
- Understand how to make appropriate use of technologies to communicate, collaborate, solve problems, make decisions, and conduct research, as well as foster creativity and life-long learning.
Will I have to come to campus during the program?
No, you will not be required to come to campus during this program. However, we do love to see you so please stop by to say hi if you decide to visit Drexel’s campus.
- Master of Laboratory Animal Science
- MS in Biomedicine and Business
- MS in Biomedicine and Digital Media
- MS in Biomedicine and Entrepreneurship
- MS in Biomedicine and Law
- MS in Clinical Research Organization and Management
- MS in Clinical Research for Health Professionals
- MS in Drug Discovery and Development
- MS in Immunology
- MS in Infectious Disease
- MS in Molecular Basis of Cancer
- MS in Molecular Medicine
- Certificate of Study in Clinical Research
- Certificate in Drug Discovery and Development
- Post-Baccalaureate Certificate in Molecular Basis of Cancer
- Post-Baccalaureate Pre-Medical Certificate Hybrid Program
- Quantitative Principles for Clinical Research Certificate
State restrictions may apply to some programs.
Regulatory Affairs for Cell and Gene Therapy I
Regulatory Affairs for Cell and Gene Therapy II
Electives (choose 2)
World Wide Regulatory Submissions
Current Issues in Review Boards
International Regulatory Affairs
Intro to Clinical Trials
- Four-year bachelor’s degree
- Degree in science is preferred but not required
- Minimum cumulative grade point average (GPA) of 3.0 is strongly preferred
With multiple ways to submit documents, Drexel makes it easy to complete your application. Learn more by visiting our Completing Your Application Guide.
- A completed application
- Official transcripts from all universities or colleges and other post-secondary educational institutions (including trade schools) attended
- Three letters of recommendation from instructors or professionals
- If you received your degree within the last five years, it is strongly recommended that at least one letter of recommendation be provided by someone familiar with your academic qualifications and potential (e.g., your undergraduate advisor, a course instructor, or your research mentor)
- If you are requesting a letter from someone at your place of employment, the recommendation should be provided by a supervisor (or another more senior manager) with direct knowledge of your work and should address your scientific aptitude as well as your work ethic
- Additional requirements for International Students
Official test scores from graduate and professional admission exams, such as the Graduate Record Examination (GRE), Graduate Management Admission Test (GMAT), Law School Admission Test (LSAT), or Medical College Admission Test (MCAT), are optional but highly desirable.
The tuition rate for the academic year 2023-2024 is $1305 per credit.
For the academic year 2023-2024, students enrolled in an online graduate academic program will be charged a graduate online program fee of $125 per year.
- This program is not eligible for Financial Aid.
- Special tuition rates are available for Drexel University Alumni, Military members, and members of our Partner Organizations.
- These rates apply only to new online students and students being readmitted.
- These rates apply only to fully online courses. Hybrid or on-campus courses may have different rates.
- Tuition rates are subject to increase with the start of each academic year in the fall term.
- All students must contact applyDUonline@drexel.edu within the first two weeks of the term to request tuition savings for which they qualify.
- Special rates cannot be combined. If you qualify for more than one special rate, you'll be given the one with the largest savings.
- When receiving special tuition plans with Drexel University Online, you may not combine them with other tuition benefits that may be available from Drexel University.
2023-2024 Academic Year
August 21, 2023
December 15, 2023
January 8, 2024
May 3, 2024
May 13, 2024
August 2, 2024