Educational Resources
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 or you may peruse the
Lectures and Modules
FDA CERSI Collaborative Workshops & Training
- - 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: , ,
FDA CERSI Lecture Series and CERSI Webinars
- - 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,
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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,
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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.
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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.
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For a list of past lecture series and CERSI webinars by year: , ,
- : (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. , November 12-14, 2019 Recording |
- - 1 day Clinical pharmacology course that is usually offered to Commissioner’s Fellows
- : 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: , , Clinical Research Training On-Line Course for Principal Investigators (Continuous open registration),
- (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).
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and Lectures from the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation.
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Harvard School of Public Health - Course on Statistical and Quantitative Methods for Pharmaceutical Regulatory Science (Distinguished Visiting Lecturer: Robert O'Neill, PhD).
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This is a new FREE bimonthly webinar series on regulatory science topics. No registration is required for now. See the website for more details.
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- includes a variety of short instructional videos on regulatory topics.
Case Studies
- - 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 on Drug Marketing, Advertising, and Communications.
Careers and Professional Development