Clinical Research & Medical Device 1 credit courses
Regis now offers one credit courses through the Regulatory & Clinical Research Management (RCRM) department which provide an intimate look at some of the topics that are at the forefront of regulatory/clinical practice in the industry with our expert faculty.
Courses may be taken as part of the MS program, or independently for professional development. Students do not need to be accepted into a program to enroll in the 1 credit courses.
Contact the Office of Graduate Admission for a current semester schedule or to register: 781.768.7330 or firstname.lastname@example.org, or RCRM program director, Dr. Joel Feinblatt, email@example.com, 781.768.7008 for more information.
RA 630 Combination Products
(Virtual Classroom Available) In this interactive course, participants are exposed to examples of combination products on the market, under development, and on the drawing board. The course concludes with a look at the future of medicine including tissue engineering, nanotechnology. Current medical products, no matter how well designed, can only do so much to address many of the clinical problems today. To tackle the clinical problems of the future, combination products, medical devices used in combination with drugs and biologics, will be used to treat a wide range of diseases. The best-known example of a combination product, the drug-eluting stent, is a primitive example of a combination product. Quintessential examples are tissue-engineered products. They are composed of cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices).
RA 631 Personalized Medicine
This course introduces the burgeoning new field of personalized medicine. Identification of disease and disease risks at the molecular level is enabling a new generation of diagnostics based on identifying gene variants and biomarkers. Several companies in the area have initiated programs in this area.
RA 632 Quality System Auditing
This course teaches fundamental auditing skills. We are still exploring having the ASQ Quality System Auditing certification examination at the end of the course.
RA 633 Chinese Medical Device Regulation
This course introduces the student to the basics of Chinese regulations for medical devices and in-vitro diagnostic (IVD) reagents. It presents the process of product approvals by China State Food & Drug Administration (SFDA) as well as the issues that a regulatory manager may face. The course prepares the student to manage a China device approval. At end of the course, students should be able to describe the China regulatory process to others in an organization, initiate a registration, and manage potential issues. Virtual Classroom available. Fall 2012 Schedule – 4 class meetings - 9/10,17,24,10/1.