A non-thesis, part-time program, the MS in Regulatory Science program requires 30 credits of coursework and is taught exclusively online.
Each six-credit course consists of about 70 hours of pre-recorded lectures, seven hours of live web conferencing, and 13 hours of active-learning instruction. In addition, there are individual projects, as well as team presentations and mini-reviews. The fall and spring semesters are approximately 15-16 weeks and typically start towards the end of August and the end of January, respectively. The summer semester is approximately eight weeks, and typically starts at the end of May or beginning of June.
In most instances, candidates who have earned a BA or BS degree in an area of science, health or policy, engineering, or business from a US or international institution are adequately prepared to successfully complete the program, provided they satisfy other admission requirements. Because it is conducted exclusively online, the program does not require in-person attendance in Baltimore.
Sequence of Courses:
- Drug, Biologic, and Device Regulation (Year 1, Fall Semester)
- Drug and Biologics Discovery (Year 1, Spring Semester)
- Drug and Biologics Development (Year 1, Summer Semester)
- Clinical Research (Year 2, Fall Semester)
- Regulated Products in the Marketplace (Year 2, Fall Semester)
This online course is designed to orient students of diverse professional backgrounds to several practical elements that underpin drug, biologic, and device regulation in the US and around the world. It provides the core for the curriculum and is a pre-requisite for all other courses. Elements that are explored are the legal framework for drug regulation, including events that have shaped today's framework; ethical issues in drug/biologic/device development and drug/biologic/device use; global regulatory guidance approaches; types of communications with Food and Drug Administration (FDA), including Investigational New Drug (IND) application, New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) requirements, and 510(k) clearance and Premarket Approvals / Biologics Licensing Applications (PMA/BLA) approval requirements; chemistry, manufacturing, and control (CMC) issues; and post-marketing topics.
Pharmaceutical sciences are fundamental to the discovery of new medicines and impact clinical success. This online course is designed to orient students to the basic concepts in drug chemistry and functional groups, medicinal chemistry approaches to optimizing drug action, principles of pharmacology, biological and target considerations in drug design, and how drugs are metabolized and eliminated from the body.
Drug candidates and active pharmaceutical ingredients (API) need to be successfully delivered and must exhibit acceptable toxicology. This course follows drug discovery and examines key aspects of drug development, including drug formulation and quality, stability testing, pharmacokinetic characterization, bioequivalence, preclinical toxicology, methods of bioanalysis, and non-clinical and clinical Good Laboratory Practices (GLPs). Aspects of biologics will also be discussed.
Well-designed clinical research is essential in the development process of a medication or device and in generation of the knowledge base for evidence-based medicine and health policy. This online course is designed to uncover the ingredients of clinical research and to orient students of several important issues with current clinical studies. The students will learn how to design and implement different clinical studies. The role of each clinical phase in drug/device development and their various study designs and regulatory issues will be explored. The course will also discuss the Principles of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and how to successfully manage clinical trials. Additionally, knowledge of personalized medicine and behavioral/social issues in drug use will be taught.
FDA approval for the marketing of the drug or other regulated product (e.g., biologics, vaccines, medical devices, laboratory tests) is a major milestone in a product's lifecycle. But it doesn't stop there. Once on the market, how a drug is used and by whom, entry of competing products into the marketplace, and changes in medical care can change the benefit-risk balance. This course covers the breadth of clinical research and surveillance activities take place in the post-approval phase of a regulated medical product's lifecycle. This includes pharmacovigilance and risk management activities, pharmacoepidemiology, pharmacoeconomics, comparative effectiveness, and drug utilization research. The course is designed to prepare students to communicate across the pre-/post-marketing divide, evaluate the need for post-marketing studies, and to be able to critically interpret and apply the results of such studies.
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