viernes, 7 de marzo de 2014

CDER SBIA Update: Webinar on The Drug Supply Chain Security Act: Overview & Implementation

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

CDER SBIA Webinar on The Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act):
Overview & Implementation - March 12, 2014
On Wednesday March 12, 2014, at 2 pm EDT, CDER Small Business and Industry Assistance (CDER SBIA) will present a webinar entitled The Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act): Overview & Implementation.

The purpose of this webinar is to highlight key aspects of the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act), FDA’s implementation plan for the law and the docket currently open for comment regarding Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.

Speaker: 
Ilisa B.G. Bernstein, Pharm.D., J.D.
Deputy Director, Office of Compliance
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)


To register for this Event, please go the following link: https://collaboration.fda.gov/sbia0312/event/registration.html
(Registration password needs to be 8 characters and alphanumeric)

CDER SBIA Webinar Online-Access Instructions:  
To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance.
Closed captioning will be provided.

  
Presentation Information 
 Federal Register (FR) Notice: Federal Register (FR) Notice February 20th, 2014, docket # FDA-2014-N-0200; Title of docket: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.
  
For More Information:  
Click on Workshops and Webinars in Spotlight box


The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA 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/CDERSBIA_Evaluation

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