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Master of Science in Regulatory and Clinical Research Management (RCRM)
The health care field is fast-paced and changing. Regulatory professionals work in companies and agencies to ensure products are safe and effective, and the design, manufacturing, and testing of products comply with regulations and standards. Regis College’s Master of Science Degree in Regulatory and Clinical Research Management is designed to help students navigate the increasingly complex areas of drug, device and biologics regulatory affairs, health economics and reimbursement, health policy and development, and clinical trial management. Candidates for this program are those men and women who wish to advance in professional training or seek a career in the biotechnology, device, and pharmaceutical industries or academic research environment. This program allows the student to focus on one of two specialty tracks including Product Regulation and Clinical Research Management. Electives allow the student to take the courses for both tracks or to pursue other areas of interest. Our students acquire skills, knowledge, and field experience that provide the necessary credentials to enhance or enter careers in regulatory affairs, clinical affairs, and health policy. Students in the MS in Regulatory & Clinical Research Management complete 11 courses of study (33 credits), which include six core courses including a field experience project, three additional courses for the candidate’s specialty track, and two elective courses. The program is flexible to fit the schedule of working professionals through evening, weekend, and virtual class options. The program can be completed in fifteen months by those who choose to take accelerate the program by taking three courses during most terms. Two non-Regis College graduate courses, relevant to the program, may be transferred from other accredited graduate schools with the approval of the Program Director. Certificates in Regulatory Management or Clinical Research may be obtained with the completion of four courses within the subject area.
- Overview of the Health Product Industry (RA 601)
- Overview of Health Product Regulation (RA 602A)
- Biostatistics (HP 600)
- Health Ethics and Law (HP 601)
- Advanced Writing for the Health Professions (HP 603)
- Field Experience (RA 605)
Product Regulation Specialty Track*
- Pharmaceutical Product Regulation (RA 603A)
- Medical Device Regulation (RA 604A)
- Risk Management and Quality Systems (RA 615)
Clinical Research Specialty Track*
- Clinical Research Methods (RA 608)
- Clinical Trial Management (RA 609)
- Project Management (RA 616)
* Students must choose between Product Regulation and Clinical Research Specialty Tracks. Students may take elective courses from the specialty track not selected.
- Health Policy (NU 618)
- Clinical Pharmacology (NU 620)
- Other graduate Communications courses (CO 6xx)
- Other graduate Health Profession courses (HP 6xx)
- Combination Products (RA 630)
- Personalized Medicine (RA 631)
- Chinese Medical Device Regulation (RA 633)
(Students currently enrolled in the RCRM program will be charged program tuition for 1 credit. Non-degree seeking students enrolled in the one credit courses will be charged $1000/credit. The one credit courses do not satisfy the special student option of taking two courses prior to enrolling in a program).
Other graduate courses may be taken as electives with the consent of the Regulatory & Clinical Research Management program director, Dr. Joel Feinblatt, firstname.lastname@example.org.