lunes, 9 de octubre de 2017

Clinical Pharmacology Corner: FDA Announces CDER Labeling Conference for November 1 and 2, 2017

FDA Announces CDER Labeling Conference for November 1 and 2, 2017

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) will host a two-day Regulatory Education for Industry (REdI) conference on labeling titled “Prescription Drug Labeling Conference 2017” on November 1 and 2, 2017. 

The goal of this interactive conference is to provide helpful information pertinent to prescription drug labeling development. 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.  

Featured topics include: 
  • Considerations for Best Labeling Practice
  • Best Practices 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
  • Safety Considerations for Patient Instructions to Minimize Medication Errors and Incorporating Health Literacy into the Development and Testing of Patient Labeling
  • Improving Data Quality of SPL Labeling Submissions
The date, time, location, and other details of the workshop are as follows:

Date: November 1 and 2, 2017
Time: 8:30 am – 4:15 pm 

The agenda for the workshop is available here.

Registration is free and can be accessed hereYou may register to attend in-person or virtually. 

This conference is pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

There is an optional, self-pay networking event with colleagues after the conference adjourns on November 1 from 5:00 pm – 7:00 pm at the Tommy Douglas Conference Center Lounge & Recreation Center in Building 4 (5 minute walk from the conference). 


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