Program Overview
Johns Hopkins University's Master of Science in Regulatory Science prepares students to become leaders in the regulation of medical products, primarily delivered online for full-time working adults. The curriculum aims to equip students with knowledge and skills to address industry challenges, focusing on medical products' regulations, both in the US and internationally. Graduates will be able to justify regulatory recommendations, analyze clinical trials, develop regulatory strategies, and collaborate in diverse teams.
Program Outline
Degree Overview:
The Master of Science in Regulatory Science program at Johns Hopkins University is designed to prepare students to become leaders in the regulatory field. The program focuses on the regulation of medical products, including drugs, biologics, and devices, both in the U.S. and internationally. The curriculum is designed to equip students with the knowledge and skills necessary to address current and future challenges in the industry.
Objectives:
The program aims to:
- Prepare students to become fluent in the regulation of medical products.
- Equip students with the knowledge and skills to address current and future challenges in the regulatory field.
- Develop the next generation of interdisciplinary professionals in regulatory science.
Program Description:
The program is primarily delivered in an online format and is designed for full-time working adults. The faculty consists of industry professionals from both private enterprise and government.
Other:
- The program requires an undergraduate degree in the natural sciences or engineering with a GPA of at least 3.0.
- The program requires one semester of biochemistry and one semester of cell biology.
- The program consists of 10 courses: 7 core required courses and 3 electives.
- The electives are chosen from the Center for Biotechnology Education courses.
- Graduates of the program will be equipped to:
- Justify recommendations to pursue a particular regulatory/clinical path from a legal and scientific point of view.
- Identify the relationships between clinical trials, the approval process for medical products, and the impact of labeling.
- Demonstrate the ability to apply guidances and evaluate all aspects of clinical trials.
- Develop a regulatory strategy document for a medical product.
- Analyze the requirements of Good Manufacturing Practices regulations for medical products.
- Examine the relationships between medical product development and underlying scientific principles.
- Identify the legal and regulatory requirements for all stages of medical products.
- Demonstrate the ability to communicate scientifically, both orally and in writing.
- Demonstrate the ability to collaborate in a diverse group to achieve an objective.
-
Entry Requirements:
- Undergraduate Degree: An undergraduate degree in the natural sciences or engineering is required.
- GPA: A minimum GPA of 3.0 on a 4.0 scale is required.
- Additional Requirements:
- Resume
- Statement of Purpose: Discuss your reasons for pursuing the MS in Regulatory Science degree, your long-term goals, how this program will complement those goals, and the strengths of your academic and professional background.
- Required Courses:
- One semester of biochemistry
- One semester of cell biology