|
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
|
