CDER Prescription Drug Labeling Conference
December 4 & 5, 2019
Continuing Education Credit
- This two-day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- This event has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
- SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- Real-time attendance is required for attendance certificates which are only available during the two weeks after the event.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 5, uploaded on November 27, 2019.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
Session Recordings:
The links to the recordings (below) will become active within 24 hours after each session concludes.
Day One:
- Voluntary PLR Conversions and Updating Prescribing Information: Eric Brodsky
View Recording - Indications and Usage Section of Labeling Draft Guidance and Drug Abuse and Dependence Section of Labeling Draft Guidance: Iris Masucci
View Recording - Adverse Reaction Information in Labeling: Jeanne Herndon
View Recording - Pediatric Information Incorporated Into Labeling Guidance: Eric Brodsky
View Recording - The Pregnancy and Lactation Labeling Rule: Four Years In – What’s next?: Miriam Dinatale and Kristie Baisden
View Recording - Labeling Case Study: Transformation of an Indication: Ann Marie Trentacosti
View Recording - Q&A Panel
View Recording - Labeling Finalization – Improving the Format and Appearance of the Prescribing Information: John Gallagher
View Recording - Improving the Accuracy of Structured Product Labeling Submissions: “The Missing LOINC”: Farrokh Sohrabi
View Recording - Q&A Panel
View Recording
Day Two:
- Labeling for Biological Products: Ruby Wu and Jessica Greenbaum
View Recording - A Recipe for Clinical Pharmacology Information in Labeling That is Easy to Digest: Joseph Grillo
View Recording - Instructions for Use Draft Guidance: Morgan Walker
View Recording - Product Title and Initial U.S. Approval in Highlights of Prescribing Information Draft Guidance: Debbie Beitzell
View Recording - Drug Product Nomenclature: Jibril Abdus-Samad
View Recording - Q&A Panel
View Recording - Safety Considerations for Container Labels and Carton Labeling to Minimize Medication Errors: Chi-Ming (Alice) Tu
View Recording - Improving Consistency of Information in the Prescribing Information and Carton/Container Labeling: Eric Brodsky
View Recording - Q&A Panel & Closing
View Recording
Questions?
Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.
More Information
If you have questions regarding the content of the event or other CDER-specific information, please:
- Visit the CDER SBIA website
- Learn more about CDER SBIA Workshops and Webinars
- Subscribe to the CDER SBIA email updates
- Follow us on LinkedIn