|
Day |
Time |
Topic |
Speaker |
|
8
月28日(一) |
08:30-09:00 |
Registration |
|
09:00-09:10 |
Opening address |
Dr. Sheng-mou Hou
(DOH-Minister)
Dr. Gan-lin Chen
(PDC-President) |
|
09:10-09:20 |
Guest address |
EU ECO.
and Trade
office-director
EC Commission |
|
09:20-10:30 |
Overview of EU
medical device regulation |
Dr. Antonio Lacerda
(Head
of Sector Medical Devices, European
Commission) |
|
10:30-10:50 |
Coffee break |
|
10:50-12:00 |
Competent
authorities, Designating
authorities, Notified Bodies-Scopes
of responsibilities |
Dr. Antonio Lacerda
or
other delegate
|
|
12:00-13:20 |
Lunch |
|
13:20-14:30 |
Clinical Data
Evaluation-
Medical Devices
Directive 93/42/EEC
|
Mr. Bernard Lambert
(President
of the EU Notified Bodies Group for
Medical Devices) |
|
14:30-14:50 |
Coffee break |
|
14:50-16:00 |
European device
vigilance system
Post-Market studies |
Dr. Miguel Antunes
(Director
of Medical Devices Dept., INFARMED,
Portugal) |
|
16:00-16:30 |
Q & A |
|
8
月29日(二) |
09:10-10:20 |
Future trend of GHTF-
SG5 |
Dr. Wolfgang Ecker
(Federal
Ministry of Health and Women, Dept.
for Pharmaceuticals and Medical
Devices, Austria) |
|
10:20-10:40 |
Coffee break |
|
10:40-11:50 |
German device
regulatory system
|
Dr. Rainer
Edelhaeuser
(Director
of Medical Devices Dept., ZLG,
Germany) |
|
11:50-13:10 |
Lunch |
|
13:10-14:20 |
Austria device
regulatory system |
Dr. Wolfgang Ecker |
|
14:20-14:40 |
Coffee break |
|
14:40-15:50 |
Portugal device
regulatory system |
Dr. Miguel Antunes |
|
15:50-16:20 |
Q & A |