University of California Center for Accelerated Innovation

Events

The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling (Webinar)

Type: CAI Only
Start Date: June 19, 2017 10:00 AM
End Date: June 19, 2017 11:30 AM
Location: Webinar. See information below.
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The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), webinar series presents two REMS topics including: 

A presentation of 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.

You will have an opportunity to submit questions during a live Q&A session after the presentation.

Featured speaker:  
Mongthuong Tran, Pharm.D., BCPS
Labeling and Health Communication Specialist
Office of Clinical Pharmacology Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

The following people will be involved in the Q&A discussion:  
Joseph A. Grillo, Pharm.D.
Associate Director for Labeling and Health Communication
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration  

Catherine Miller
Labeling and Health Communication Specialist
Office of Clinical Pharmacology
Office of Translational Sciences Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Kimberly L. Bergman, Pharm.D.
Labeling and Health Communication Team Lead
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Eric Brodsky, M.D.
Associate Director, Labeling Development Team
Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

The CDER SBIA webinars 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.

See complete details here

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


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