Working Group of Quality Managers Meeting

  • 9-10 December 2024

Register

Venue of the Meeting

Marble hall of the Ministry of Interior
Budapest, József Attila u. 2-4, 1051

Venue of the Welcome Event

Városliget Café

Budapest, Olof Palme prom. 5., 1146

Venue of the Gala Dinner

Városliget Café

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

Hotel Moments Budapest

 

Middle category

Hotel Central Basilica

Hotel Erzsébet City Center

Prestige Hotel Budapest

Boutique Residence Budapest

D8 Hotel

Three Corners Downtown Hotel

Carat Boutique Hotel

Host City

The Host-City Budapest

The capital of Hungary, known by many as the "Pearl of the Danube", is undoubtedly one of the most beautifully located cities in the world. The River Danube runs through the middle of the metropolis of two million, dividing hilly Buda with its narrow-cobbled streets and mixture of mediaeval and neo-classical buildings from the flat area of Pest with its wide boulevards. The picturesque panorama offered by the river and its bridges, the Parliament building, the imposing Royal Castle, the Fishermen's Bastion and the impressive Danube Embankment led UNESCO to place this site on the World Heritage list.

Visitors will find side by side the remains of fortresses and buildings from Roman times, still-functioning Turkish baths, Gothic and Baroque buildings, and the incredibly rich Art Noveau architectural heritage. There is no other capital city in the world which can boast close to 100 thermal springs and 12 medicinal baths, where 19 million gallons of thermal water rise to the surface each day.

It is a city where the pleasing harmony of different architectural styles and superb structures, the cafés, gastronomy and culture are combined with the legendary Hungarian hospitality, blending into an unforgettable experience for visitors.

Budapest is the venue for numerous congresses, international meetings, sports competitions and cultural events, with its developed infrastructure, elegant shops and modern hotels. Budapest’s cultural life is widely renowned, with more than 20 theatres and also ample to explore! 

Badge

Access to the meeting venue requires a valid personalized badge, which can be obtained after the registration request had been approved and the accreditation is confirmed by a confirmation message. Badges will be distributed at the conference venue upon arrival. Delegates will receive one single badge for the event. Please make sure to wear your badge visibly at the official programme venues.

Please note that all participants are required to carry on their ID cards or passports, in order to comply with the on-the-spot identification process.

In case of loss of a badge, please report it immediately to This email address is being protected from spambots. You need JavaScript enabled to view it. The validity of the badge will be immediately terminated, while the organisers will create a new badge upon your request.

For further information regarding the badges of any delegate, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

Interpretation

The Conference will be held in English, without the use of interpretation services.

Transportation from the Airport to the city

  • Delegates who arrive with a commercial flight will arrive to Terminal 2A or 2B of Budapest Liszt Ferenc International Airport. Delegation participants are responsible for their own travel arrangements.
  • Budapest Airport Shuttle Service: Budapest Airport itself offers an airport shuttle service for an extra fee, called MiniBUD (www.minibud.hu ).
  • Public Transport (Budapest Transport Centre – BKK): Public transport bus line 100E Airport Express provides a direct and fast connection to the city centre. Single ticket costs 2.200 HUF, tickets can be purchased at the ticket machines at the airport. For more information regarding public transportation within the city, please consult the website of BKK, where you can also learn about the costs of different types of tickets and information on public transport routes: https://bkk.hu/en

  • Taxi: At your landing spot, Budapest Liszt Ferenc International Airport, you have the opportunity to book a taxi to get you to your accommodation. The official partner of Budapest Airport is Főtaxi (tel. +36 1 222 2 222, https://fotaxi.hu/en/). Főtaxi operates a designated office outside of the arrival terminal.

Facilities

The NCPHP will provide all necessary services, such as a cloakroom, internet connection at the official meeting venue. The Wi-Fi password will be provided at the location.

Media

Photographs and video footage from events will be available on its official channels and may be used free of charge with a clear mention of the NCPHP.

For any media-related questions, please contact us at the following email address: This email address is being protected from spambots. You need JavaScript enabled to view it.

Other practical information

  • Emergency number: 112 (fire brigade, medical assistance)
  • Electricity: The voltage in Hungary is 230V, 50 Hz.
  • Local time: Central European Summer Time Zone (CEST) – GMT +2:00
  • Country code: Hungary +36
  • Currency: The official currency of Hungary is the Hungarian Forint. For official daily exchange rates, please consult the website of the Magyar Nemzeti Bank (National Bank of Hungary): https://www.mnb.hu/en/arfolyamok
  • Weather in Hungary: https://met.hu/en/idojaras/
  • Tap water: Hungarian water is regularly tested for quality and is safe to drink.
  • Smoking: Smoking is only allowed in the designated area of the official meeting spaces.

Contact information

Should you have any questions regarding the logistical aspects of the event, or about the details of the programme, please contact us at the following e-mail address: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

© 2026 National Center for Public Health and Pharmacy (NCPHP)