Capstone

The Capstone is an intensive project focused on your specific area of interest within Regulatory Affairs. You will develop a detailed Capstone project with defined goals and objectives and should formulate your Capstone around a deliverable that will position you for the next step in your career. The project will be implemented under the direction of a Capstone Advisor, and you are encouraged to select your Capstone Advisor for their expertise in the topic being addressed. You are responsible for leading the design, implementation, and analysis of your work. Your Advisor will guide you, but you will drive the Capstone forward.

During the Spring of your first year in the program, you will develop your project proposal in the REG 6400 — Capstone I course. After your proposal has been approved through the successful completion of this course, you will begin your Capstone project in the third term (Summer) of your first year in the program. The final product of the project will be a deliverable that explains the background of your project, why it is important to study, how you addressed your Capstone, and the outcomes. Your final deliverable will be evaluated by the Capstone Course Director(s) with input from your Capstone Advisor. You will earn two credit units for completion of the Capstone — one for completion of an approved Capstone proposal (REG 6400) and the second for completion of the Capstone project (REG 6410).

Capstone Titles

Training Programs

• Creation, Implementation, and Evaluation via Compliance Parameters of a Continuing Drug Manufacturing Compliance Education Program within the Penn Cyclotron Facility
• Tackling Learning Gaps and Operational Deficiencies in the Field of Regulatory and Compliance Using Tailored Educational Workshops
• A Training System and Reference for High Throughput Xenograft Modeling in Immune Deficient Mice 

Targeted Regulatory Guidance

• Regulatory Pathway Guide for New Medical Devices and Technology at the University of Pennsylvania
• Developing an Internal Regulatory Guidance Document for Filing a Companion Diagnostics Application
• Guidance Toward Implementing a GLP Compliance Program in an Academic Setting: Overcoming Challenges and Pitfalls
• Evaluation of Gaps & Challenges in Developing Rare Disease Registry Endpoints: A Case Study of PRO Endpoints in Registries for CDKL5 Deficiency Disorder and Spinal Muscular Atrophy
• Implications Affecting Regulatory Preparation and Workflow for Continuing Reviews: Site-level Differences when Using Local or National IRB (CIRB) in Oncology
• Review of the Proposed Model of Regulation for Plant Biostimulants and Guidance on Their Use

Process Improvement

• Developing a New Master Manufacturing Batch Record
• Risk-based Monitoring of Gene Therapy Clinical Trials for Hereditary Retinal Degeneration
• Implementation of the CNT Imaging Core Data Collection and Analysis Pipeline
• Preclinical Data Collection for Successful IDE Submission
• Quality Management Systems at an Academic Research Institution: Development and Implementation of a Pilot Quality Management System at the University of Pennsylvania
• Evaluating Timelines, Processes, and the Downstream Operational Activation Impacted by Differences in IRB Review Models
• Review of Direct-to-Consumer Advertisement Regulations in Direct Across Worldwide Regulatory Bodies

​​​​​​​Articles

• Trends in Reporting to the FDA Adverse Events Reporting System (FAERS)
• Evaluating the Impact of the New Informed Consent Ruling from the Pennsylvania Supreme Court
• CAR-T Therapy Product Development and Approval in the US for the Treatment of Orphan Diseases
• Deception in Human Subjects Research and the Effect of Subject Payment: Subjects’ Views and Staff Views
• Longitudinal Study to Assess Long Term Comorbidities in Women with PCOS-Longitudinal PCOS
• Evaluating the Impact of Chinese Regulatory Reforms from 2015-2020
• Review and Recommendations Related Virtual Reality (VR) Design as it Relates to Chronic Pain
• Exploration of How Social Media Data is Used in Post-marketing Pregnancy Drug Safety Research