jueves, 21 de noviembre de 2019

Update - CDER SBIA: Prescription Drug Labeling Conference – Dec. 4-5, 2019



Dec. 4-5, 2019 | College Park, MD | Free
An interactive conference providing information on prescription drug labeling development and discussing recently published FDA labeling guidances.
Agenda
Day 1 - Wednesday, December 4
  • Updating Labeling 
  • Indications and Usage Section of Labeling Draft Guidance and Drug Abuse and Dependence Section of Labeling Draft Guidance
  • Adverse Reaction Information in Labeling 
  • Pediatric Information Incorporated Into Labeling Guidance 
  • The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? 
  • Labeling Case Study: Transformation of an Indication
  • Labeling Finalization - Improving the Format and Appearance of the Prescribing Information 
  • Improving Structured Product Labeling Submissions 
Day 2 - Thursday, December 5
  • Labeling for Biological Products
  • A Recipe for Clinical Pharmacology Information in Labeling That is Easy to Digest 
  • Instructions for Use Draft Guidance
  • Product Title and Initial U.S. Approval in Highlights of Prescribing Information Draft Guidance 
  • Drug Product Nomenclature 
  • Safety Considerations for Container Labels and Carton Labeling to Minimize Medication Errors 
  • Improving Consistency of Information in the Prescribing Information and Carton/Container Labeling
INTENDED AUDIENCE
Our 2019 CDER Prescription Drug Labeling Conference is intended for industry, academia, payors, healthcare information providers, and healthcare providers who:
  • Review, develop, submit, or use the Prescribing Information, Instructions for Use, and/or carton/container labeling
  • Create or submit Structured Product Labeling files to the FDA
  • Review, develop, submit, or use the Prescribing Iinformation, Instructions for Use, and/or carton/container labeling
  • Create or submit Structured Product Labeling files to the FDA

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