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  5. CDER SBIA REdI: Prescription Drug Labeling Conference 2017, November 1-2, 2017
  1. Development & Approval Process (Drugs)

CDER SBIA REdI: Prescription Drug Labeling Conference 2017, November 1-2, 2017

CDER SBIA REdI: Prescription Drug Labeling Conference 2017, November 1-2, 2017

Image of Redi Conference November

                  Prescription Drug Labeling Conference 2017  
      November 1 & 2      8:30am - 4:15pm Eastern                        
    Attend In-Person or Virtually
             Registration for this event is FREE

 

FDA’s Center for Drug Evaluation and Research, Small Business and Industry Assistance (CDER SBIA) Regulatory Education for Industry (REdI) invites you to attend our two-day labeling conference in person or virtually.

The goal of this interactive conference is to provide helpful information pertinent to prescription drug labeling development.  Both FDA and industry labeling specialists will present their unique perspectives concerning approaches and challenges in developing the prescribing information, patient labeling, and Structured Product Labeling (SPL).  Meeting participants will have an opportunity to share their experiences and ask questions during the question and answer panels.  

Conference Topics include:

  • Consistency in Labeling, Methods to Optimize Communication in Labeling
  • Considerations for Developing the INDICATIONS AND USAGE Section of Labeling
  • Converting Labeling for Older Drugs from the Old Format to the PLR Format
  • Novel and Adaptive Labeling Approaches: PLR and Beyond
  • Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling
  • Two Years In: Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) and PLLR: Industry Perspective and Learnings
  • Patient Labeling:  Safety Considerations for Patient Instructions to Minimize Medication Errors and Incorporating Health Literacy into the Development and Testing of Patient Labeling
  • Overview of SPL at Novartis, Overview of SPL at FDA, and SPL Data Challenges with Medication Guide Extraction and Data Mining”

 

Advance registration is required.
When you register, you may choose to attend either on-site at the Tommy Douglas Conference Center (TDCC) or virtually online via Adobe Connect. We ask that you please honor your registration commitment. If you need to change your registration status, please email us at cancelation@SBIAevents.com.

Continuing Education
This 2 day conference has been pre-approved by RAPS as eligible for up to 12 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 more information on
CDER SBIA
(866)-405-5367 | (301)-796-6707 | CDER Small Business and Industry Assistance

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