Drugs

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling - June 19th 2017 - 1:00pm - 2:30pm (Eastern)

Image of SBIA Webinar 2016

 

 

This event is FREE
 

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.
These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
CDER's LIVE webinar: The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling was held on June 19th, 2017.

Our experts from the Office of Clinical Pharmacology presented highlights from the FDA guidance, Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, and key prescription drug labeling regulations. After completion of this activity, the participant will be able to:

  • Understand key regulations that impact clinical pharmacology content in prescription drug labeling (also referred to as prescribing information or package insert (PI)).
  • Describe where clinical pharmacology content is found in prescription drug labeling. 
  • Describe the content structure of the Clinical Pharmacology section in prescription drug labeling. 
  • Identify alternative methods of communicating complex clinical pharmacology content.  

 

Featured Speaker:

Mongthuong Tran, Pharm.D., BCPS
Labeling and Health Communication Specialis
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
CDER | FDA

Panelists:

Kimberly L. Bergman, Pharm.D.
Labeling and Health Communication Team Lead
OCP | OTS
CDER | FDA

Eric Brodsky, M.D.
Associate Director
Labeling Development Team
Office of New Drugs (OND)
CDER | FDA

Joseph A. Grillo, Pharm.D.
Associate Director for Labeling and Health Communication
OCP | OTS
CDER | FDA

Catherine Miller
Labeling and Health Communication Specialist
OCP | OTS
CDER | FDA

 

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits
towards a participant’s RAC recertification upon full completion.

Please note that the credit is only available for participation in the live
            event and not for watching the recording afterwards.

For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707

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