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CDER Small Business Update: Reminder - 4th Annual Great Lakes cGMP & Regulatory Science Forum

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business

FDA/CDER's Small Business Assistance


4th Annual Great Lakes cGMP & Regulatory Science Forum 

This event is being held at the UIC Forum, in downtown Chicago, on September 18-19, 2012.  This four-session forum will be two full days and includes breakfasts, lunches, and a networking reception.  Space is limited and early registration is encouraged. 
 
Registration fee:
Industry: $575.00
Government/Academia: $300.00
Student: $150.00
 
Plenary Sessions:

Day 1 – “Willpower: Rediscovering the Greatest Human Strength”, Roy F. Baumeister, Ph.D.

Day 2 – “What You Need to Know About Human Factors Compliance”, Ed Israelaski, Ph.D.

Sessions:  

* Quality by Design Controls for Combination Products
* Post Market Safety: Balancing the Risks and the Benefits

* Responding To and Preventing Drug Shortages
* What’s Changing in Post Approval Changes

Chicago Trolley Tour:
This year there is an optional evening activity following the reception on Tuesday, September 18: a 2-hour Chicago Trolley Tour from 6:00-8:00pm.  The cost is $20.00 and you can register on the website. 

Registration:

To register, please visit: http://www.regonline.com/GreatLakes2012

 

Below are links to the agenda and registration.


The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business 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 SBA staff.  If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM.

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


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