• 专业概况
• 所属院系
• 中国学生入学要求
• 课程信息

专业概况

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 MSRS 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.

Program Objectives

The primary objective of the Master of Science in Regulatory Science (MSRS) 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 MSRS 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 MSRS 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. MSRS 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.

Thesis Project

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.

所属院系

中国学生入学要求

课程信息

学制：全日制(12 )

学费：

开学时间：2022六月21日

申请截止日期：

留学地点：School of Medicine3400 Civic Center Boulevard Building 421,PHILADELPHIA,Pennsylvania,19104, United States