Food and Drug Administration Drug Safety and Risk Management Advisory Committee (DSaRM) Holiday Inn, the Ballroom Read Patricia Staub's Presentation AGENDA |
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| 8:00 | Call to Order and Opening Remarks | Peter Gross, M.D. Chair, DSaRM |
| Introduction of Committee | ||
| Conflict of Interest Statement | Shalini Jain, PA-C, M.B.A. DSaRM, Executive Secretary | |
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| Issue: | Current screening methods to assess sound alike and look alike proprietary drug names, in order to reduce the incidence of medication errors resulting from look alike and sound alike names. | |
| 8:15 | Welcome | Paul Seligman, M.D., M.P.H. Director, Office of Pharmacoepidemiology & Statistical Science Acting Director, Office of Drug Safety, ODS FDA |
| 8:20 | Advancing the Science of Proprietary Drug Review | Paul Seligman, M.D., M.P.H. |
| 8:40 | PhRMA: Views on Trademark Evaluation | Robert E. Lee, Jr., J.D. Assistant General Patent Counsel Eli Lilly and Company representing the Pharmaceutical Research and Manufacturers of America (PhRMA) |
Brand Specialist |
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| 9:00 | Proprietary Name Evaluation at FDA | Jerry Phillips, R.Ph. Associate Director, Medication Error Prevention, ODS FDA Brand Specialist |
| 9:20 | Automatic String Matching for Reduction of Drug Name Confusion | Bonnie Dorr, Ph.D. Assistant Professor Dept. of Computer Science University of Maryland |
| 9:45 | Questions to the presenters | |
| 9:50 | Evaluating Drug Name Confusion Using Expert Panels | Richard Shangraw, Jr., PhD. CEO - Project Performance Corporation |
| 10:15 | Questions to the presenter | |
| 10:20 | Break | |
| 10:35 | Focus Group Methodology | Miriam Bar-Din Kimel, Ph.D. Senior Project Manager MEDTAP International |
| 11:00 | Questions to the presenter | |
| 11:05 | Use of Laboratory and Other Simulations in Assessing Drug Name Confusion | Kraig Schell, Ph.D. Assistant Professor Dept. of Psychology Angelo State University |
| 11:35 | Quantitative Evaluation of Drug Name Safety Using Mock Pharmacy Practice | Sean Hennessy, PharmD, Ph.D. Assistant Professor Dept. of Epidemiology & Phramacology Center for Clinical Epidemiology & Biostatistics University of Pennsylvania School of Medicine |
| 12:00 | Questions to the presenters | |
| 12:05 | Lunch | |
| 1:00 | Open public hearing | |
| 2:00 | Introduction of the Issues for Discussion | Paul Seligman, M.D., M.P.H. |
| 2:15 | Committee Discussion of Issues/Questions | |
| 3:00 | Break | |
| 3:15 | Continuation of Committee Discussion | |
| 5:00 | Adjourn | |
Read Patricia Staub's Presentation
Brand Specialist
