Master of Regulatory Science
Regulatory Science is defined by the FDA as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA regulated products. Nationally it is considered to be critical that there is a body of trained individuals capable of performing the research that will provide a basis to:
- improve capacity for safety and efficacy evaluations and monitoring of candidate and licensed products,
- modernize current regulatory pathways, and
- develop new regulatory pathways where there are currently none.
The MRS and affiliated MRA programs are designed to create a culture of professionals and scientists who promote science-based regulation and drive knowledge and acceptance down the pipeline.
The primary objective of the Master of Regulatory Science (MRS) degree program is to produce a cadre of highly trained and sophisticated investigators adept in the skills necessary to become leaders in the field of regulatory science.
The MRS provides trainees with in-depth instruction in the fundamental skills, methodology, and principles necessary to become a well trained investigator positioned for a future career as a successful academic researcher. The program is designed to meet these objectives through:
- the provision of didactic course work,
- a primary thesis project,
- a formal mentorship program,
- and specific ongoing guidance with hands-on exposure to protocol and grant development.
Upon successful completion of the MRS program, graduates are expected to have developed a strong foundation in the fundamental techniques of research. They should be able to apply contemporary research tools to relevant areas of investigation. MRS trainees will learn how to independently formulate meaningful hypotheses, design and conduct interpretable experiments, adhere to good laboratory and clinical practices, analyze results critically, understand the broad significance of their research findings, and uphold the highest ethical standards in research. The development of additional skills—including oral and written communication, grant writing, and laboratory management—are considered integral to this training.
Trainees are expected to complete a primary research project of their own design under the supervision of their primary mentor. The research should address a new tool, standard, or approach to assess the safety, efficacy, quality, and performance of an FDA-regulated product.
Trainees are expected to develop, implement, and analyze the data collected from the research project and summarize the results in a publishable manuscript(s). The thesis project provides hands-on experience in: formulating one or more research questions; searching the medical literature; translating research question(s) into an appropriate research design; assessing study feasibility; writing a detailed study protocol; designing data collection instruments; conducting the research; performing data analysis, where appropriate; and preparing a manuscript for publication. The primary protocol should account for at least 75-80% of the student's commitment to the program.
Effective mentoring is critical not only for research training but also to allow the trainee to develop into an independent investigator. Mentoring requires that the primary mentor dedicate substantial time to ensure personal and professional development. A good mentor builds a relationship with the trainee that is characterized by mutual respect and understanding. Attributes of a good mentor include being approachable, available, and willing to share his/her knowledge; listening effectively; providing encouragement and constructive criticism; and offering expertise and guidance. We recognize the importance of these attributes and the significant time required to mentor effectively. For this reason we have in place a formalized mentoring program.
Prospective students will meet with the program director before or during the application process. The student’s research interests, plan of study, and mentoring committee composition will be discussed at this time. The student identifies the primary and secondary mentors at the time of application.
Perelman School of Medicine | 8035 Maloney Building | 3400 Spruce Street | Philadelphia, PA 19104-4283 | 215-614-1835