Heads of Medicines Agencies Meeting (on-line)

08:30 - 08:55

(Only HMA)

SG updates-HMA Pharma Review - Head of SG 

08:55 - 09:00

Technical break

09:00 - 09:12

(With IT Directors)

Opening of 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)

09:12 - 09:15

Technical break

09:15 - 09:45

(Only HMA)

Adoption of the Agenda and Minutes from the 116th HMA Plenary - Rita Pálffy-Poór Deputy Chief Officer of NCPHP

09:45 -09:55

(Only HMA)

HMA-MG Report-Update - MG Chair ??

09:55 -10:40

(Only HMA)

European Commission - DG Sante Update - Rainer Becker (DG SANTE)

EMA –Update - Emer Cooke (EMA)

EMANS to 2028 - Progress update and preparation for public consultation - Rui Santos Ivo (INFARMED), Thomas Heberer (BVL) and Michael Lenihan (EMA)

(Only HMA)

10:40 -10:50

Break

10:50 -11:40

(With IT Directors)

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

(With IT Directors)

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

(Only HMA)

European Platform for Regulatory Science Research (EPRSR) - Roelie Marinus, Aimand Torqui

13:40-13:55

(Only HMA)

Regulatroy Optimisation Group (ROG) - Runa Hauksdottir Hvannberg, (IMA), Zaide Frias (EMA), Aimad Torqui (MEB)

13:55 -14:25

(Only HMA)

Big Data Steering Group (BDSG) report + Rationalisation of the network data governance - Jeppe Larsen (DKMA), Peter Arlett (EMA) and Hilmar Hamann (EMA)

14:25 -14:40

(Only HMA)

Spanish Presidency 2023 - Maria Lamas-AEMPS

14:40 -14:50

(Only HMA)

Veterinary Sectors's actualities from HU PRES - National Food Chain Safety Office - Gábor Kulcsár

14:50 -15:20

(Only HMA)

ACT EU Update and CTIS  - TBC

15:20 -15:30

(Only HMA)

AOB, Closing of the meeting - Rita Pálffy-Poór Deputy Chief Officer of NCPHP

15:30 -15:45

(Only HMA)

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)