Master of Engineering in Pharmaceutical Engineering


The Master of Engineering in Pharmaceutical Engineering Program is currently under review and revision by the College of Engineering. It is currently closed to new students. If you would like to be notified in the event that the application is re-opened, please complete this inquiry form.

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Regulatory Science Concentration

Program Overview

Accelerating discoveries in molecular biology and genetics are energizing the development of new and improved pharmaceutical processes, products, and therapeutic agents. As companies work to turn the process of developing new medicines from an art to a well-understood science, there is also a growing opportunity for individuals with regulatory science expertise.

The pharmaceutical, biotechnology, medical device, and other health-related industries are among the most regulated to ensure product safety and efficacy. With the exception of small discovery companies engaged only in research, each must have experts devoted to regulatory and legal issues. The primary function of these regulatory professionals is to serve as the direct link between the company and various global regulatory agencies such as the US Food and Drug Administration (FDA). They must understand and execute an extensive list of laws, regulations, guidelines, and guidance from regulatory agencies. They must also interact within the company, communicate with other departments within the company, and understand the organization, procedures, and technical operations so that the entire organization can successfully fulfill regulatory and legal responsibilities.

The new regulatory professionals must possess a scientific background with additional statistical and quality training. Knowledge of current concepts such as various Good Regulatory Practices (GxPs) and the International Conference on Harmonization (ICH) are part of their education and training.

We need scientists, bioengineers, and managers who can function in this new global science and risk-based regulatory environment who have comprehensive knowledge of regulatory affairs, dosage formulation, and clinical issues as well as skills such as scientific computing, database and information management, and automation. They are essential to carry out effective work functions for the drug design, pre-clinical, and clinical development of various traditional pharmaceuticals and new biologics as well as novel biomedical devices and combination products

Degree Requirements

The Master of Engineering in Pharmaceutical Engineering requires a total of 30 credit hours of course work, of which at least 24 credit hours must be graded (not satisfactory or unsatisfactory), and at least 18 graded credit hours must be in courses at the 500 level and above. A minimum grade point average of 5.0/9.0 (i.e., a "B" average) is also required. Each entering student will be assigned to a faculty advisor and must obtain the advisor's approval for the overall program of study and semester courses. Each student is allowed to take up to 3 credit hours on an assigned clinical research project to satisfy the degree requirement. Besides several required core courses (ChE/Pharm 519 and 597), the student can elect the remaining courses according to individual interest within the clinical development and engineering concentration framework as described in the sample schedule below.

Prerequisites

  • Bachelor's degree in engineering or related science discipline.
  • Two years of college mathematics or equivalent.
  • Undergraduate coursework in the following areas: human physiology; statistics and technical communications. Students without such background must take remedial courses before embarking on the degree program.
  • The equivalent of two years of full time industrial experience in pharmaceutical and related industries. Students with outstanding qualifications who do not have two years of industrial experience can be considered for admission if they have relevant summer internship or co-op experience.
  • The Graduate Record Examination (GRE) is required for all students who have not previously earned a degree from the University of Michigan. (Students seeking financial aid must submit GRE scores).

Sample Schedule

Incoming students must obtain approval from their faculty advisor for the planned M. Eng. in Pharmaceutical Engineering degree courses selected. A faculty advisor will be assigned to the student upon admission. Up to 6 credit hours of research based on a capstone project that utilize the student's knowledge and apply it to an industrially relevant problem. The project must receive prior approval by the student's advisor.

Course offerings are subject to change. Check University course listings for details.

1. Pharmaceutical Engineering Core Courses (15 credit hours)
Course NumberCreditsTermTitle
ChE/Pharm 519 3 F Modern Pharmaceutical Engineering
ChE/Pharm 596 1 TBD Health Science and Engineering Seminar Series
ChE/Pharm 597 2 F Regulatory Science for Scientists, Engineers and Managers
ChE 520 2 alt. W Applied Pharmacokinetics and Toxicokinetics
HMP 652 3 F Health Law
IOE 461 3 W Quality Engineering
Stat 465 3 W Design of Experiments
Biostat 619 2 F Clinical Trials
2. Pharmaceutical Engineering Practical Training or Research (3 credit hours)
Each student must take at least one advanced science/engineering course and one advanced statistics or biostatistics course from the following list:
Course NumberCreditsTermTitle
PharmSci 570 3 F/W Research
ChE 695 3 F/W Research Problems
Eng 600 3 F/W Industrial Practicum

Other advanced engineering and statistics/biostatistics courses may be used. The students should check with their advisor and Program Director for approval before taking these courses.

3. Advanced Science/Engineering and Statistics/Biostatistics Cores (6 credit hours)
Each student must take at least one advanced science/engineering course and one advanced statistics or biostatistics course from the following list:
Course NumberCreditsTermTitle
Math 417 3 F/W Matrix Algebra (if no linear algebra taken before)
Stat 503 3 F Applied Multivariate Analysis
Biostat 619 2 F Clinical Trials
Pharmcol. 611 2 W Principles of Pharmacology
EHS 506 2 F Principles of Toxicology
BME 410 4 F Design and Applications of Biomaterials
ChE 520 3 alt W Applied Pharmacokinetics and Toxicokinetics
Pharm 761 2 alt W Population Pharmacokinetics
EECS 484 4 F, W Database Management System
Stat 415 3 W Data Mining and Statistical Learning
Biostat 690 3 W Health Applications of Multivariate Analysis
HMP 668 3 W Health Informatics
ChE 531 3 F Introduction to Chemoinformatics
PharmSci 7xx 3 TBD Pharmaceutical Product Development
ChE 517 TBD alt F Biopharmaceutical Manufacturing Science
Bioinf 526 3 F Fundamentals of Bioinformatics
ChE 696 3 W Synthetic and Systems Biology

Other advanced science, engineering and statistics/biostatistics courses may be used. The students should check with their Concentration advisor and Program Director for approval before taking these courses.

4. Regulatory Science Concentration Classes (at least 3 credit hours)
Course NumberCreditsTermTitle
Psych 449 3 F Decision Processes
EHS 508 2 W Principles of Risk Assessment
IOE 460 2 F Decision Analysis
IOE 591 3 W Designing for Quality

A list of approved technical and regulatory electives in DL mode from other universities is available and can be used to fulfill this requirement. For each student, a maximum of 9 credit hours may be taken and transferred from other accredited institutions subject to prior approval of the UM faculty advisor and the Program Director.