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.

Spring 2 (March-May) | Instructor: Marco Schito, PhD, C-Path and College of Law

What are the fundamental incentives for development in the biomedical space? The topics covered in this course include introducing key concepts in oversight by the Food and Drug Administration, biologics and biosimilars, regulation of diagnostics, along with the medical device development and approval process. Proving safety and efficacy in clinical development and promoting innovation through the adoption of new technologies and novel adaptive trial designs will also be discussed. The course concludes with a survey of Intellectual Property rights regime for medical products and the regulatory challenges in international markets.

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.  

Fall & Spring | Co-instructors: Leila Barraza, JD, MPH, College of Public Health and Elizabeth Hall Lipsy, JD, MPH, College of Pharmacy

This course explores the intersection of regulation and science, focusing on how regulators at federal and state levels can best accommodate science and how science can best be practiced to satisfy regulators. The course discusses the role of executive agencies such as the Food and Drug Administration (FDA) in ensuring safe and effective products to promote public health, different mechanisms executive agencies use to increase compliance and current challenges for enforcement in a globalized world.

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