REdI Workshop
The Regulatory Education for Industry (REdI) Program was established in 2012 as a FDA-led forum that brings together the regulatory educators from FDA's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). Program is free.
Goal:
To provide direct, relevant, and helpful information on the key aspects of drug and device regulations.
Audience:
Small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.
Program Series and Format:
- Starting in 2018, REdI is held annually.
- REdI is held at a different location in the United States. We try to go to areas of the country with a high concentration of new businesses.
- The program is two days: Day 1 address premarket topics. Day 2 address postmarket topics.
- REdI features a plenary session that combines the themes of drug and device regulatory policy. Prior topics have featured: Combination Products, Companion Diagnostics, Products for Rare Diseases and Pediatrics, and Human Factors.
- The program is delivered in a hybrid format: you may attend in person or remotely through Adobe Connect.