- December 04-05, 2019
08:00 AM - 05:00 PM EST
Event LocationThe Hotel
at the University of Maryland
7777 Baltimore Ave.
College Park, MD 20740
Digital LocationAttend in-person or online
- Organized By:
Registration will open in October 2019.
This event is FREE and open to the public. You may attend in-person or online.
The goal of this interactive conference is to provide useful information on prescription drug labeling development and discuss recently published FDA labeling guidances. FDA labeling specialists will present their unique perspectives concerning approaches and challenges in developing the Prescribing Information, FDA-approved patient labeling, and carton/container labeling, and will discuss methods to improve the quality of Structured Product Labeling (SPL) submissions.
Meeting participants (in-person and online) will have an opportunity (as time allows) to share their experiences and ask questions during dedicated Q&A panels.
- Updating labeling
- Overview of recently published FDA labeling guidances:
- Indications and Usage section of Labeling guidance
- Drug Abuse and Dependence Section of Labeling guidance
- Incorporating specific population information in labeling (e.g., pediatric patients, pregnant patients, lactating patients, and females and males of reproductive potential)
- Clinical pharmacology information in labeling
- Product quality information in labeling
- Labeling for biological products
- FDA-approved patient labeling (instructions for use)
- Methods to improve the quality of Structured Product Labeling submissions
Our 2019 CDER Prescription Drug Labeling Conference is intended for industry, academia, payors, and healthcare providers who
- 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
- Explain correct labeling when submitting New Drug Applications, Biologics License Applications, and/or supplements.
- Identify recommendations from new FDA guidances into future labeling submissions (e.g., indications; pediatric use information; abuse, misuse, addiction, tolerance, and dependence information; and the product title and Initial U.S. Approval in Highlights of Prescribing Information)
- Distinguish between different requirements and recommendations in biological product labeling and drug product labeling
- Incorporate pregnancy, lactation, and females and males of reproductive potential information in labeling
- Revise clinical pharmacology information in labeling according to recently published guidances
- Differentiate between different dosage form terminology in labeling
- Demonstrate clear, concise, and well-understood Instructions for Use for products that have complicated or detailed patient-use instructions
- Analyze the quality of Structured Product Labeling file submissions
KEYNOTE FDA SPEAKERS
Eric Brodsky, M.D.
Associate Director, Labeling Development Team (LDT)
Office of New Drugs Policy (ONDP) Staff | Office of New Drugs (OND) | CDER | FDA
Miriam Dinatale, D.O.
Maternal Health Team Leader
Division of Pediatric and Maternal Health (DPMH) | OND | CDER |FDA
LaShawn Griffiths, MSHS-PH, B.S.N., R.N.
Associate Director for Patient Labeling
Division of Medical Policy Programs | Office of Medical Policy Initiatives | Office of Medical Policy (OMP) | CDER | FDA
Joseph Grillo, Pharm.D
Associate Director for Labeling and Health Communication
Office of Clinical Pharmacology | Office of Translational Science | CDER | FDA
Tamara Johnson, M.D., M.S.
Maternal Health Team Leader
DPMH | OND | CDER | FDA
Iris Masucci, Pharm.D
Special Assistant for Labeling
OMP | CDER | FDA
Ann Marie Trentacosti, M.D.
Medical Lead, LDT
ONDP Staff | OND | CDER | FDA
CONTINUING EDUCATION CREDITS
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion
- is eligible for SOCRA credit 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. Candidate must provide documentation of participation.
- 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.
- is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
FDA’s PLR Requirements for Prescribing Information website provides resources for the development of human prescription drug and biological product labeling regulated under New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications:
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit: Adobe Connect Diagnostic Test
Please contact firstname.lastname@example.org for all technical questions.
For Reasonable Accommodations
If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: email@example.com.