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Educational Resources

The 2021 FDA Science Forum

The 2021 FDA Science Forum is being held virtually on Wednesday and Thursday, May 26-27, 2021. The Forum is highlighting the keynote speaker NIAID Director Dr. Anthony Fauci, "Science as the Foundation for protecting and Promoting Public Health."

The Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists. You'll get a chance to see first-hand how FDA's researchers are using novel science and technologies to inform FDA’s regulatory decision-making — and drive innovation.

FDA scientific experts and nationally renowned scientists will speak on the eight topics of the 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health, highlighted below.

The Science Forum agenda can be found here or you may peruse the 2021 FDA Science Forum Brochure

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).

FDA CERSI Collaborative Workshops & Training

2021- For a list of current workshops & training.
- 2021 Innovations in Regulatory Science Summit- Sunday, January 10, 2021.
- For a list of past workshops & training by year: 2020, 2019, 2018

FDA CERSI Lecture Series and CERSI Webinars

2021- For a list of current workshops & training.
- March 10, 2021- Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data, UCSF-Stanford CERSI, Atul Butte, MD, PhD, Priscilla Chan and Mark Zuckerberg Distinguished Professor, Inaugural Director of the Bakar Computational Health Sciences Institute, University of California, San Francisco (UCSF). For more information, click here
- June 9, 2021- Use of Social Media to Fortify Regulatory Science, Johns Hopkins University CERSI, Mark Dredze, PhD, John C. Malone Associate Professor, Department of Computer Science, Johns Hopkins Whiting School of Engineering. For more information, click here
- September 16, 2021 - Outsourcing Facilities and Bulk Drug Substances: University of Maryland Research Projects, University of Maryland CERSI, Ashlee Mattingly, PharmD, BCPS, Assistant Professor of Pharmacy Practice and Science, University of MD. More information coming soon.
- November 9, 2021 - Long COVID: risk factors, symptomology and patient reported outcomes captured through a novel digital platform, Yale Univ.-Mayo Clinic CERSI, Erica Spatz, MD, MHS, Assistant Professor of Medicine (Cardiology), Yale University, Arjun Venkatesh, MD, MBA, MHS, Associate Professor, Department of Emergency Medicine, Yale University. More information coming soon.
- For a list of past lecture series and CERSI webinars by year: 2020, 2019, 2018
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, November 12-14, 2019 Recording | Slides
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.
ReGARDD Program - includes a variety of short instructional videos on regulatory topics.

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