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CDER Small Business Assistance Industry Workshop - San Francisco
Wednesday, September 28, 2011 at 8:00 AM - Thursday, September 29, 2011 at 3:00 PM (PDT)
San Francisco, CA
This two day event will be held in two California locations consecutively. The first workshop will be held in Los Angeles, CA. on September 26-27, 2011, followed by a second in San Francisco, CA. on September 28-29, 2011.
The purpose of this workshop is to educate the small pharmaceutical industry on FDA regulations and requirements as they pertain to different stages of the drug development process. CDER hopes to expand our outreach and encourage maximum attendance by offering the workshop in two separate locations.
Topics to be presented include:
- Clinical Trial Design - The phased approach and the staged approach
- FDA's Bioresearch Monitoring (BIMO) Inspection Program
- Challenges to conducting clinical research in the 21st Century
- Practical concerns of electronic source documentation
- Different types of pharmacokinetic studies conducted during drug development
- Importance of bioequivalence studies
- Strategic Quality for Clinical Trials
- FDA Inspection Process
- eCTD (Electronic Common Technical Document)
- ESG (Electronic Submissions Gateway)
- eDRLS (Electronic Drug Registration and Listing)
Wednesday - September 28 / 8:00 am to 5:00 pm
Thursday - September 29 / 8:00 am to 3:00 pm
Program Details: CDERSmallBusiness@fda.hhs.gov or Brenda Stodart - (301) 796-3400
Registration Details: email@example.com or 1-855-770-2997