The American College of Clinical Pharmacology and the Pediatric Pharmacy Advocacy Group announce a Joint Symposium: Should Off-Patent medications be Labeled for Pediatric Use? The symposium will be held during the ACCP Annual Meeting on Saturday, September 16, 2017 in San Diego, CA.
Topics and Speakers:
Are off-patent off-label medications a problem in pediatric therapeutics today?
John Bradley, M.D. Professor of Clinical Pediatrics University of California, San Diego
The BPCA program for labeling off-patent medications
Anne Zajicek, M.D., Pharm.D. Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch National Institute of Child Health and Human Development, NIH
What is the standard for adding a drug and monograph to a pediatric formulary: Institutions, Systems and PBMs
Jennifer Le, Pharm.D. Professor of Clinical Pharmacy University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences
What Evidence Is Required for Changing an FDA label?
Lynne Yao, M.D. Director, Division of Pediatric and Maternal Health Office of New Drugs, Center for Drug Evaluation and Research, US FDA
Can Opportunistic Studies Be Expanded to Provide Sufficient Evidence for Labeling: Proof of Concept
Kevin Watt, M.D., Ph.D. Asst. Professor of Pediatrics Pediatric Trials Network Duke Clinical Research Institute
The value of the drug label to point of care pediatrics
Jeremiah Momper, Pharm.D., Ph.D. Assistant Professor Skaggs School of Pharmacy University of California San Diego
Panel Discussion: Controversies, Challenges and Case Presentations
For more information and/or to register for the conference, visit the ACCPharmcol website.