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CDER Small Business Assistance Industry Workshop - Los Angeles

FDA CDER Small Business Assistance

Monday, September 26, 2011 at 8:00 AM - Tuesday, September 27, 2011 at 3:30 PM (PDT)

Los Angeles, CA

CDER Small Business Assistance Industry Workshop - Los...

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Type End Quantity
CDER 2 Day Small Business Workshop - Los Angeles Ended Free  

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Event Details

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)


WORKSHOP TIMES

Monday -   September 26 /   8:00 am to 5:00 pm

Tuesday - September 27 /   9:30 am to 3:30 pm


CONTACT INFORMATION

Program Details: CDERSmallBusiness@fda.hhs.gov or Brenda Stodart - (301) 796-3400

Registration Detailsevents@darpr.com or 1-855-770-2997

Have questions about CDER Small Business Assistance Industry Workshop - Los Angeles? Contact FDA CDER Small Business Assistance

When & Where


Sheraton Los Angeles Downtown Hotel
711 S.Hope St.
Los Angeles, CA 90017

Monday, September 26, 2011 at 8:00 AM - Tuesday, September 27, 2011 at 3:30 PM (PDT)


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Organizer

FDA CDER Small Business Assistance

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