REdI Workshop
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!
Goal:
To provide direct, relevant, and helpful information on the key aspects of drug, device, and biologics regulations.
Audience:
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!
Day 1: July 19 – Keynote, Plenary, and Drugs Track
Day 2: July 20 – Drugs Track
Day 3: July 21 – Devices Track
Day 4: July 22 – Devices and Biologics Tracks
Day 5: July 23 – Biologics Track