Spring 2014 FDA Small Business Regulatory Education for Industry (REdI) Conference

An amazing opportunity to interact with FDA experts to learn about FDA drug & device regulations...

This conference is free of charge, and will be held June 16-17, 2014

at the Hyatt Regency near the San Francisco Airport.

Highlights of the Drug Track include:

Opportunities for Interactions with FDA

Investigational New Drug and New Drug Applications

How to prepare for a successful meeting with CDER

Drug Inspections

Improving your Quality Submissions through the Product Lifecycle

Compliance Considerations for Importing and Exporting Drugs

Immunogenicity of therapeutic protein products

Pediatric Drug Development

Agenda and Registration information are posted online.

For more information on CDER Small Business Assistance workshops and webinars, visit: http://www.fda.gov/cdersbia

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

Email: CDERSBIA@fda.hhs.gov

Phone: 1-866-405-5367

Phone: (301) 796-6707

Website: http://www.fda.gov/cdersbia

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation