SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Prescription Drug Labeling Conference 2017 – Files Page

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November 1:

Meeting Objectives, Labeling Resources for Industry, PLR Implementation, Labeling Guidances
Eric Brodsky, MD
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SESSION #1: Considerations for Best Labeling Practice
Eric Brodsky, MD
Melissa Beaman
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SESSION #2: Best Practices for Developing the INDICATIONS AND USAGE Section of Labeling
Jeanne Herndon, MD
Eric Brodsky, MD
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SESSION #3: Converting Labeling for Older Drugs from the Old Format to the PLR Format
Farrokh Sohrabi, MD
Ingrid Bryzinski, MS, RPh
Slides in ZIP file above
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SESSION #4: Novel and Adaptive Labeling Approaches: PLR and Beyond
Eric Brodsky, MD
Ann Marie Trentacosti, MD
Slides in ZIP file above
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November 2:

SESSION #5: Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling
Joseph A. Grillo, PharmD
Roya Behbahani, PharmD, MBA
Slides in ZIP file above
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SESSION #6: Improving Data Quality of SPL Labeling Submissions and Overview of SPL at Novartis
Corey Schmidt, MBA
Lonnie Smith
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SESSION #7: Two Years In: Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR)
Tamara Johnson, MD, MS
Miriam Dinatale, DO
Jane Liedtka, MD
Traci Lee, PharmD
Slides in ZIP file above
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SESSION #8: Safety Considerations for Patient Instructions to Minimize Medication Errors and Incorporating Health Literacy into the Development and Testing of Patient Labeling
Ebony Whaley PharmD, BCPPS
Laurie Myers, MBA
Danielle Harris
Slides in ZIP file above
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