REdI Workshop
The Regulatory Education for Industry (REdI) Program is an FDA-led forum that brings together the regulatory educators from 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!
Goal:
To provide direct, relevant, and helpful information on the key aspects of drug and device regulations.
Audience:
Small manufacturers who want 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.