Download the Agenda
The session recordings will be available to registered participants only.
September 29:
| PLENARY: Drug / Device Combinations: a Union to Deliver the Best Medical Product to Patients James Bertram & Kristina J. Lauritsen, Ph.D. |
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Device Track: |
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| Device Classification Overview William M. Sutton |
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| Device Clinical Trials and the IDE Program Soma Kalb, Ph.D. |
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| The 510(k) Program LCDR Kimberly Love Piermatteo |
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| Best Practices & Interactions w/CDRH Sergio M. de del Castillo |
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| Labeling Overview Eric Richardson |
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| Wrap Up and Q&A All the Day’s Speakers |
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Drug Track: |
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| Safety Considerations for Product Design, Container Labels, and Carton Labeling and Best Practices in Developing Proprietary Names for Drugs Lubna Merchant, M.S., PharmD |
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| Good Clinical Practice (GCP) Inspectional Perspective on Use of Electronic Records and Signatures in Clinical Trials Kassa Ayalew, M.D., M.P.H. |
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| Comparing Safety Report Requirements for Pre and Post Market Chrissy J. Cochran, Ph.D. |
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| Pediatric Drug Development: Regulatory Expectations Alyson Karesh |
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| Clinical Outcome Assessment Implementation in Clinical Trials Jessica Voqui, PharmD, M.S. |
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September 30:
Device Track: |
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| Overview of Quality Systems Regulation Tonya A. Wilbon |
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| Design Controls Stanley Liu |
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| Purchasing Controls Aileen Velez-Cabassa |
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| Process Validation Joseph Tartal |
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| Unique Device Identification (UDI) Loretta E. Chi, JD |
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| Electronic Medical Device Reporting (eMDR) Andrew Xiao |
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| FDA Medical Device Inspections Marc Neubauer, B.S., M.A. |
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| Wrap Up and Q&A All the Day’s Speakers |
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Drug Track: |
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| Overview of FDA Expedited Programs with a Focus on the Breakthrough Therapy Miranda Raggio, BA, BSN, MA |
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| FDA’s Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome Denise DiGiulio, R.Ph. |
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| CDER Regulatory Applications – Investigational New Drug and New Drug Applications Balajee Shanmugam |
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| Lifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. |
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| Lifecycle Management of Drug Products Hasmukh B. Patel, Ph.D. |
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| Evidence and Data Requirements for NDA Submissions Eileen Navarro, M.D., FACP |
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| Demystifying Interactions with FDA-CDER: A Primer on Formal Meetings and Best Practices Judit Milstein |
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