Skip Main Navigation
Page Content
This event has ended

CDER Small Business Assistance Industry Workshop - San Francisco

FDA CDER Small Business Assistance

Wednesday, September 28, 2011 at 8:00 AM - Thursday, September 29, 2011 at 3:00 PM (PDT)

CDER Small Business Assistance Industry Workshop - San...

Ticket Information

Type End Quantity
CDER 2 Day Small Business Workshop - San Francisco Ended Free  

Share CDER Small Business Assistance Industry Workshop - San Francisco

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

Wednesday - September 28 / 8:00 am to 5:00 pm

Thursday -      September 29 / 8:00 am to 3:00 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 - San Francisco? Contact FDA CDER Small Business Assistance

When & Where


Hilton San Francisco Union Square
333 O'Farrell Street
San Francisco, CA 94102

Wednesday, September 28, 2011 at 8:00 AM - Thursday, September 29, 2011 at 3:00 PM (PDT)


  Add to my calendar

Organizer

FDA CDER Small Business Assistance

  Contact the Organizer

Interested in hosting your own event?

Join millions of people on Eventbrite.

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.