| 08:30-09:00 |
Registration
|
| 09:00-09:15 |
Introduction
|
Dr. Yael Libal-Weksler
Quality Systems Manager, BTG |
| 09:15-10:00 |
Introduction to Medical Device Requirements |
Dr. Tamar Katsav
Program Leader, Physio-Logic |
| 10:00-10:45 |
Risk Assessment for Combination Products
|
Ari Levin
Senior Quality and Regulatory expert, Physio-Logic |
| 10:45-11:15 |
Coffee Break |
| 11:15-12:00 |
Understanding Medical Device Single Audit Program (MDSAP)
|
Yael Goldbrener
Program Leader, Physio-Logic |
| 12:00-12:45 |
Combination Product Guidelines in Europe
|
Adina Klein
Senior Manager Regulatory Affairs, BTG |
| 12:45-14:00 |
Lunch |
| 14:00-14:45 |
Combination Products in the US |
Dr. Hagit Marchaim
Regulatory Affairs and Drug Development Consultant (HMC) |
| 14:45-15:30 |
Q&A panel with all participants |
