jueves, 15 de junio de 2017

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

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

CDER invites you to our free LIVE webinar:
on Monday June 19th from 1:00pm – 2:30pm (Eastern).
Join us as our experts from the Office of Clinical Pharmacology present 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 and A session after the presentation.
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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