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This seminar is intended for drug manufacturers who are utilizing medical devices for delivery of their drug product.
It will provide an overview of FDA expectations and how they can be met from a quality, regulatory and business perspective.
Discussions will include examples of some of the issues that have been encountered in obtaining approval of combination products.
Seminar Program
| Duration |
Topic |
Speaker |
| 12:30 – 13:15 |
Registration & Lunch |
| 13:15 – 13:30 |
Overview of FDA Guidance for Combination Products |
Mark Kessler, Ph.D.
Kessler Consulting, Ltd. |
| 13:30 – 14:15 |
FDA Perspectives on Combination Products-PMOA,
Jurisdiction and Pre-submission Program |
Hagit Marchaim, Ph.D.
VP RA Alcobra Ltd. and Regulatory Affairs Consultant |
| 14:15 – 14:30 |
Coffee Break |
| 14:30 – 15:15 |
Combination Products Require Two to Tango;
the Pharma - Medical Partnership |
Tomer El Gad
Senior Business Development Manager –
Self Injection Systems
Europe and Asia Pacific
West Pharmaceutical Services, Inc. |
| 15:15 – 16:00 |
Biological and Device Combination:
Living in Both Worlds |
Roberto Meidler, PhD
Research Fellow, R&D,
Omrix |
| 16:00 – 16:30 |
Consideration in Development of Combination Products (Device with Drugs/Biologics) |
Sara Horn, Ph.D.
CEO,
Sara Horn Ltd. - Regulatory and Clinical Consultancy Services |
| 16:30 – 17:45 |
Questions & Answers |
Note: the program and speakers are tentative and subject to change without prior notice.
Target Audience
Pharmaceutical and biopharmaceutical drug manufacturers that are producing medical device and drug combination products.
Participation Fees:
PDA members - 450 NIS
Non members - 550 NIS
Become a member at the international PDA
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