URMC / Research Alliances / Regulatory Science / Education and Training / Degree Programs Educational Resources Lectures and Modules FDA's Learning Portal for Students, Academia, and Industry - Provides education and resources related to FDA’s regulatory, product quality, and safety responsibilities. FDA Education and Resources by FDA Organization - This is the FDA's portal to training. FDA Preparing INDs - This resource was specifically developed for DAVP, but several sections are generalizable. FDA Basics for Industry - How do you know if your product is regulated by the FDA. What to expect during an inspection. Where to start when you want to manufacture and FDA-regulated product. FDA Video Directory - this is a library of FDA videos covering a range of topics (initially on medical devices but will be further expanded). 2018 FDA CERSI Workshops & Training - 10/29/18 - Clinical Trials to Optimize Outcomes in Early Breast Cancer. Oncology Center of Excellence and University of California, San Francisco-Stanford CERSI. The focus of this workshop is to gather stakeholders interested in early breast cancer to discuss strategies for successful escalation and de-escalation of therapy to optimize patient outcomes. 11/13-15/18 - Clinical Investigator Training Course. CDER and University of Maryland CERSI. This course takes a deep dive into the scientific background and practical methodology needed when conducting clinical trials. Attendees will learn FDA regulations, ethical considerations, and the scientific principles to help them understand what is important when conducting clinical trials and preparing a submission for FDA review. Onsite attendance only. This event will not be webcast. 11/28/18 - Assessing and Communicating Heterogeneity of Treatment Effect in Subpopulations Challenges and Opportunities. Hosted by: Collaborative Symposium hosted by Johns Hopkins University Center of Excellence in Regulatory Science and Innovation (JHU-CERSI) and The Food and Drug Administration. Heterogeneity of treatment effects (HTE) is the variation in how individuals respond to a treatment. This is a vital and yet under-explored concept of importance to regulators, manufacturers, payors, healthcare providers, academic researchers, and patient and consumer advocacy groups. HTE is of high relevance to the FDA for product approval, labeling, and post-marketing surveillance. We propose a stimulating symposium comprised of talks and panel discussions by leading experts that engages various stakeholders in how to assess and communicate HTE. Registration is required. 2019 FDA CERSI Workshops & Training - 1/5/19 - Innovations in Regulatory Science Summit (UCSF-Stanford University CERSI) - UCSF-Stanford CERSI is pleased to present the inaugural Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development. This event is intended as a pre-conference to the 2019 J.P. Morgan Healthcare Conference. This meeting will comprise primarily of panel discussions and short research talks by CERSI investigators on ongoing collaborative research projects with FDA investigators. Registration is Required 2018 FDA CERSI Lecture Series - 9/26/18 - What Can Data Tell us About the Opioid Crisis? Presented by William C. Becker, MD, Associate Professor of Medicine Yale School of Medicine. Dr. Becker will explore the roots of the crisis, and will highlight and interpret observational and experimental data on both harms and benefits of long-term opioid therapy for pain. He will briefly review the clinical and research challenges in de-implementing risky opioid therapy. Finally, he will present emerging strategies – and their evidence – for a multi-pronged approach to mitigating the crisis. 11/5/18 - Chan-Zuckerberg Biohub: Impact on Regulatory Science. Presented by Joseph DeRisi, PhD, Co-President, Chan-Zuckerbertg Biohub, Professor of Biochemistry and Biophysics, University of California, San Francisco. More information available soon. Clinical Investigator Training Course: (Currently a 2016 course) In this intensive, three-day course clinical investigators will be trained by FDA medical officers and senior scientists--along with other experts--in all aspects of clinical studies: preclinical and clinical science, statistical structure of trials, ethical requirements, and regulatory considerations. In addition, the course will help foster communication between clinical investigators and FDA and enhance investigators' understanding of FDA’s role in experimental medicine. Agenda Clinical Pharmacology Course - 1 day Clinical pharmacology course that is usually offered to Commissioner’s Fellows NIH Training Program: The NIH has developed a course that contains aspects of drug development, clinical trials, discovery and multiple other recorded videos. It is developed as an online course. These courses comprise of lectures on the following topics: Principles of Clinical Pharmacology, Introduction to the Principles and Practice of Clinical Research, Clinical Research Training On-Line Course for Principal Investigators (Continuous open registration), Bioethics BIODESIGN Video Library (Stanford University) A video library contains nearly 300 videos that have been developed to reinforce key concepts within the biodesign innovation process (topics from need assessment and regulatory strategy to IP and reimbursement). Lectures from the UCSF-Stanford CERSI and Regulatory Science Learning Modules Lectures from the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation. Harvard School of Public Health - Course on Statistical and Quantitative Methods for Pharmaceutical Regulatory Science (Distinguished Visiting Lecturer: Robert O'Neill, PhD). Association of Graduate Regulatory Educators (AGRE) Bi-monthly Webinar Series This is a new FREE bimonthly webinar series on regulatory science topics. No registration is required for now. See the AGRE website for more details. Case Studies FDA's National Medical Device Curriculum - The FDA offers a series of fictional case studies to help science and technology innovators understand FDA's medical device regulatory processes. Case studies are free and take about 3 hours of student preparation. Case Studies include: Regulatory Pathways for Medical Devices, Safety Assurance and Risk Management, Bringing a Device to Market, and more. More information is available on the FDA website. For questions, contact NMDC@fda.hhs.gov. FDA's "Educational Case Studies" on Drug Marketing, Advertising, and Communications. Careers and Professional Development Explore a range of career and professional development opportunities at the FDA.