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:

Product Complexity
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.

Development Process
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 Framework
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.

Program Features

• 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

Program FAQs

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.

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