Venue of the Meeting
Marble hall of the Ministry of Interior
Budapest, József Attila u. 2-4, 1051
Venue of the Welcome Event
Budapest, Olof Palme prom. 5., 1146
Venue of the Gala Dinner
Budapest, Olof Palme prom. 5., 1146
08 DECEMBER (SUNDAY) - Welcome event
09 DECEMBER (MONDAY)
| 08:30-09:00 | Registration |
|
09:00 –09:05 |
Welcome by the HU presidency Rita Pálffy-Poór PharmD Deputy Medical Chief Officer, NNGYK |
|
09:05 –09:10 |
Adoption of the Agenda - Chair |
|
09:10 –09:20 |
Welcome of new members &tour de table - WGQM |
|
09:20 -09:30 |
Minutes of the last meeting& matters arising - Chair |
|
09:30 -09:35 |
Review of WGQM documents-Chair |
|
2 |
WS 1 Quality management standards, including external assessment |
|
09:35-09:50 |
BEMA V update – Mateo Oresic, HALMED |
|
09:50-10:15 |
“The Pepper is Small but Strong”- Strengts of Small Agencies- Marta Reining, nebih |
|
10:15-10:45 |
Coffee break |
|
10:45 -11:10 |
Trend analysis: performance and effectiveness of the quality management system- Sandra Ramos, Infarmed |
|
11:10-11:40 |
“BEMA strengths”-Swedish Medical Products Agency: Leadership-Annika Weréen, MPA |
|
3 |
WS 2 Process management |
|
11:40-12:05 |
Optimatization of resources at three different levels-Martijn de Coninck, MEB |
|
12:05-13:15 |
Group foto, followed by lunch |
|
4 |
WS 1 Quality management standard, including external assessment |
|
13:15-14:45 |
Implementation of BEMA requirements for higher ratings: Evidence for effectiveness- Workshop, WGQM |
|
14:45-15:15 |
Coffee break |
|
5 |
WS 5 Best practices |
|
15:15-15:30 |
Medicinal product falsification actualities in Hungary-Gábor Takács, NNGYK |
|
6 |
WS 2 Process management |
|
15:30-15:55 |
Patient engagement in clinical trials and medical-ethical review-Louise Veltrop-Duits, CCMO |
|
15:55-16:20 |
Transparency in NCA’s: Requirements and Obligations-Bogdan Frunzaneanu, ICBMV |
|
7 |
WS 3: Risk management |
|
16:20-16:30 |
Outcome of recent business continuity exercise-Klaus Stüwe, BASG |
|
16:30-17:00 |
Status of record management project & questions arising-Klaus Stüwe, BASG |
|
10 DECEMBER (TUESDAY)
|
|
|
09:00 -09:40 |
Update on revision of EMA Policy on competing interests (Policy 0044)-Zahra Hanaizi, EMA (remote) Discussion of next version of WGQM Guide
|
|
09:40 -10:00 |
Arrangements to promote ethical behaviour in FVS- Ane Surkole, FVS |
|
10:00 -10:35 |
Risk management at ANSM discussion on actions to mitigate network weakness-Annie Dumortier, ANSM |
|
10:35-11:05 |
Coffee break |
|
8 |
WS 4 Internal Audits |
|
11:05-11:35 |
Kanban for audits-Konstancija Kruze, ZVA |
|
9 |
WS 1 Quality management standards, including external assessment |
|
11:35-12:15 |
HALMED’s integrated Quality Manual-Hrvoje Tumir, HALMED |
|
12:15-12:25 |
AOB Wrap-up and closing- Chair |
|
12:25 |
End of Meeting, followed by lunch |
Accommodation
The members of the delegations are responsible for their own reservation arrangements and covering the cost of their hotel rooms. Any additional expenses (beverages, minibar, parking, meals, laundry services, etc.) must be covered by the delegates themselves.
Our hotel recommendations:
Upper category
Kempinski Hotel Corvinus Budapest
Middle category