miércoles, 31 de mayo de 2017

Register for our upcoming CDER SBIA webinars: REMS (June 15th) and Clinical Pharmacology Information in Prescription Drug Labeling (June 19th)

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
CDER SBIA Webinars
Register for our upcoming CDER SBIA Webinars!
This LIVE extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:
  • REMS - Purpose, Process, and Challenges - An overview of FDA-required REMS for certain high-risk drugs - the purpose they serve in ensuring the benefits of certain drugs outweigh their risks, the process of developing REMS programs, and the unique challenges of the requirement for a single, shared system for generics and brand products.
  • REMS in Structured Product Labeling Format: An Introduction - An introduction to the use of structured product labeling as a format for REMS information. FDA will describe the history of the REMS SPL project, provide an introduction to SPL, and describe the role of REMS SPL in standardizing REMS and integrating them into the healthcare delivery system.
This LIVE webinar will feature experts from the Office of Clinical Pharmacology presenting 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 presentations.
These webinars have been pre-approved by RAPS as eligible for up to 3 credits each towards a participant’s RAC recertification upon full completion.
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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