The Regulatory Education for Industry (REdI) Program is an FDA-led forum that brings together the regulatory educators from the FDA's medical product centers: Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER). Program is free!
To provide direct, relevant, and helpful information on the key aspects of drug, device, and biologics regulations.
Small manufacturers, researchers, and innovators seeking to learn about how FDA regulates drugs, devices, and biologics medical products.
Program Series and Format:
- Starting in 2021, REdI features three tracks, one for each FDA medical product center: CDER, CDRH, and CBER
- 2020 and 2021: Conference is fully virtual only!
- REdI features a plenary session that combines the themes of drug, device, and biologics regulatory policy. Prior topics have featured: Combination Products, Companion Diagnostics, Products for Rare Diseases and Pediatrics, Human Factors, and Real World Evidence (RWE).
- Topics span total product lifecycle.
REdI 2021 took place over 5 days from July 19 – 23, 2021!