URMC / Research Alliances / Regulatory Science / Education and Training / Degree Programs Educational Resources Lectures and Modules: 2018 FDA CERSI Workshops & Training - SAVE THE DATE for the following scheduled workshops and trainings: 9/12/18 - Patient Engagement, 10/3-4/18 - Predictive Immunogenicity, 10/29/18 - Qualifying New Endpoints that Accelerate Drug Development in Oncology; 11/13-15/18 - Clinical Investigator Training Course. 2018 FDA CERSI Lecture Series - SAVE THE DATE for the following scheduled Lecture Series: 6/5/18 - Non-invasive quantification of drug-target engagement at the tumor, 9/26/18 - What Can Data Tell us About the Opioid Crisis?, 11/5/18 - Chan-Zuckerberg Biohub: Impact on Regulatory Science. 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 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. 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. FDA Video Directory - this is a library of FDA videos covering a range of topics (initially on medical devices but will be further expanded).