Fall 2024

Audit requirements mandated by the FDA and other international regulatory agencies, including internal, external, regulatory agency, third party, GMP, GLP, ISO 13485/QSR and supplier audits.

Fundamentals and applications of Statistical Process Control (SPC) in development and monitoring of manufacturing processes; includes SPC in root cause analysis and CAPA.

Introduction to regulatory environments surrounding medical product development, manufacturing and marketing; operation of federal, state and international regulatory bodies.

Development and testing of new medical products according to U.S. and international regulatory requirements.

Legal issues affecting intellectual property, medical product development, marketing and safety, taught through case studies and lectures.

Development and execution of clinical trials: bioethical principles, good clinical practices, project management and documentation.

Developing form and content for investigational drug applications, new drug applications, biologic licensing applications to FDA; common technical documents; considerations of writing style.

Current problems in regulatory affairs, legal management, preclinical and clinical testing, scientific evaluation and quality assurance. (Duplicates credit in former MPTX 521.) Graded CR/NC. Recommended preparation: undergraduate degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post secondary training and industry experience; enrollment in MS Regulatory Science program.

Provides a firm foundation in the domestic and international CMC process, from concept to commercialization of new active pharmaceutical ingredients and products.

Safety pharmacology/toxicology requirements mandated by FDA and other regulatory agencies to move a new chemical entity from discovery stage to market approval

Research leading to the master's degree. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.

Part-time or full-time practical work experience in Regulatory Science. The internship must be located at an off-campus facility. Students are individually supervised by faculty. Graded CR/NC. Recommended preparation: Undergraduate or professional degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience; enrollment in MS (Regulatory Science).

Theory and practice of personnel management, organizational structure and industrial relations in small, growing enterprises and large global companies typical of pharmaceutical and medical device sectors Recommended preparation: Undergraduate or professional degree in pharmacy, medical or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

Research/policy analysis conducted under preceptor supervision in an industrial or governmental setting.

Research leading to the doctorate. Maximum units which may be applied towards the degree to be determined by the department. Graded CR/NC

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Dissertation research required for completion of doctoral degree in Regulatory Science.

Preparation for the qualifying exam. Graded CR/NC