Spring I (Jan-March) | Instructor: Mabel Crescioni, DrPH, JD, LLM, College of Public Health and College of Law

This course explains the ethical principles underlying regulations and guidance governing clinical trials, especially as the principles pertain to informed consent, risk-benefit disclosure, and conflicts of interest. The course also outlines the elements and design of clinical trials, including federal regulations for research with human subject participants, with vulnerable populations, and international research ethics. The course concludes with research ethics in big data.

Fall 1 (Aug-Oct) | Co-Instructors: John-Michael Sauer, PhD and Jennifer Burkey, PhD, C-Path and College of Law

This course navigates the drug development path stretching across the pre-clinical and post-marketing divide to cover the full range of drug regulation, including drug discovery, innovative drug development tools, and the post-approval phase. Intellectual Property protection and evaluation will be covered, along with FDA-enforced market exclusivity and FDA-expedited review programs. The course concludes with international regulatory perspectives, including the European Medicines Agency, the costs involved to bring drugs through the clinical trials to market in the US and abroad, and how this affects future investment and strategy.

Summer | Instructor: Nabil Dib, Professor, College of Internal Medicine, Law

The course focuses on the process of bringing medical devices from conceptualization to the bedside. There are a myriad of stakeholders and steps involved that this course covers from industry and regulatory agencies through all phases of translational research: from proof of concept, to preclinical investigation, clinical application, regulatory assessment, reimbursement, and post-marketing evaluation. Ultimately, this course provides students with step-by-step explanations to enable a better understanding of the science, regulations, and reimbursement in medical product development with devices, all with the aim to bring therapy to patients that improves survival and the quality of life.

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Fall 2 (Oct-Dec) | Instructor: Stephen Karpen, PharmD, C-Path and College of Law

There are numerous needs in regulatory science that companies are faced with every day. This course provides an opportunity for students to integrate and apply their knowledge and skills to real-world challenges in regulatory science. Industry leaders will present case-based projects where students will work in teams to discuss and problem-solve multi-faceted issues on a current or emerging topic in regulatory science. Students will consult scientific priority areas and consider strategies for developing new tools and approaches for improvement of safety, efficacy, quality and performance of FDA-regulated products.