lunes, 25 de septiembre de 2017

3 days left until the SBIA RedI Fall Conference – There’s still time to register!



When: September 27/28, 2017
Where: Rockville, MD or Online

*
 Register Here *  *  Agenda *
This Event is FREE.  
The Regulatory Education for Industry (REdI) Conference is an 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).

The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. 
Pre-approved by RAPS as eligible for up to 12 credits towards RAC recertification.

NETWORKING opportunities are available.
Conference Topics include:
  • CDER: Types of INDs; Chemistry, Manufacturing and Controls (CMC); Pharmacology/Toxicology; Drug Inspections
  • CDRH: 510(k); Biocompatibility in Premarket Submissions; Nonconforming Product; Device Inspections.
Don't miss this opportunity to learn about the unique issues and regulatory requirements of drugs and devices from subject matter experts!
For more information on
CDER SBIA (866)-405-5367 | (301)-796-6707 | CDERSBIA@fda.hhs.gov
CDER SBIA Learn

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