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The Information Source for Regulated Domestic and International Small Pharmaceutical Business
CDER Small Business Combination Products Webinar - February 28, 2012
On Tuesday, February 28, 2012, at 11AM (ET), we will present our webinar entitled Combination Products, which will discuss the process of classification and assignment of combination products as well as development considerations.
Dr. Kristina Lauritsen will be our presenter. Dr. Lauritsen is a scientific reviewer in the Office of Combination Products (OCP). She has been with OCP for the past 5 years, working primarily with informal and formal requests for designation. Prior to joining OCP, Dr. Lauritsen was a reviewer in the Office of Device Evaluation in the Center for Devices and Radiological Health. She joined FDA in 2003 as part of the Emerging Leaders Program in the Department of Health and Human Services. Her education includes a Ph.D. in tumor biology from Georgetown University and a B.S. in biology from Shippensburg University.
You may find some background information on Combination Products at:
Small Business Assistance > Combination Products: One plus one, two or three, equals one
Web Address for viewing: https://collaboration.fda.gov/combo/event/registration_login.html
(Presentation will last approximately 1 hr)
Registration website: https://collaboration.fda.gov/combo/event/registration.html
Call in numbers (listen only):
- Domestic: 1-888-946-6301
- International: 1-312-470-0190
- Password (verbal): FDA
For More Information: http://www.fda.gov/smallbusinessdrugs
Click on Workshops and Webinars in Spotlight box
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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