NCA IT Directors and Business Experts Meeting (on-line)

09:00 - 09:15

Opening the meeting - Cecília Müller Chief Officer of NCPHP (HU PRES)  László Németh, Head of Department (Hungary, Human) Enikő Varga, IT Director (Hungary Vet) Sean d'Art, It Director (Ireland, NICTAC chair)

09:15 - 09:45

Introduction to IT at the Hungarian NCAs - Reka Mátyás (Hungary, Human) /Balázs Scodnik Szabolcs (Hungary, Human) Enikő Varga (Hungary Vet)

09:45 -10:15

NICTAC update and EMA&NCA perspectives - Sean d’Art, IT Director (Ireland, NICTAC chair) Himar Hamann, Head of information Management (EMA, NICTA vice-chair)

10:15 -10:50

Break

10:50 -11:40

European Shortages Monitoring Platform

Business perspective - Veronika Péterné dr. Horváth, expert (Hungary, Human)

Getting your data ready for ESMP (incl. results from data mapping survey) - Sofia Zastavnik, ESMP Product Owner (EMA),& Marcos Fernandez Gomez PMS Product Owner (EMA)

11:40 - 12:20

AI use cases & demo:

Scientific Explorer - Jane Moseley, Senior Scientific Officer (EMA) &   Achilleas Voutsas, Platform Architect (EMA)

AI at DMKA - Lars Henningsen, IT Director (Denmark)

12:20-13:20

Break

13:20-13:40

Interoperable Europe Act - Roel Otterspeer, Head of CIO Office (EMA)

13:40-13:55

Progress on API management & change management process - Sokratis Kartelias, Head of Strategic Platforms Department (EMA)  Pelle Persson, IT Director (Sweden)

13:55 -14:25

Federation of identities: use cases and benefits - Elias Tavares, Head of Information Security (EMA) Carlo de Vittoria, Information Security Officer (EMA) Keith Pyper, ICT Manager (Ireland)

14:25 -14:40

Impact of Regulatory Procedures Management Product roll-out - Ramona Zemache, Technical lead (EMA) Valdemar Blazevic, domain architect for PLM value stream (EMA)

14:40 -14:50

Break

14:50 -15:20

Pharmaceutical Quality Knowledge Management task force - Sean d’Art, IT Director (Ireland, NICTAC chair)

15:20 -15:30

Update on Polish NCA IT Directors meeting - Marcin Koszewski, IT Director (Poland)

15:30 -15:45

AOB & Closing of the meeting - László Németh, Head of department (Hungary, Human), Enikő Varga, IT Director (Hungary, Vet), Sean d’Art, IT Director (Ireland, NICTAC chair), Hilmar Hamann, Head of Information Management (EMA, NICTAC vice-chair)