Final Dissemination Conference 2022

Preliminary Agenda

Dissemination Conference Agenda

  • 20th January 2022
  • 21st January 2022

20th January 2022

GAPP Dissemination Conference - Day 1

All times are CET

10:00 - 10:30 Opening Session

Welcome address

Steffan Van der Spiegel (EC, DG SANTE) | Massimo Cardillo, Director General, Italian National Transplant Centre | Vincenzo De Angelis, Director General, Italian National Transplant Centre | Lena Borboudaki (Chief, 7th Health Region of Crete) | Michael Karaviotis, (President Papageorgiou Hospital of Thessaloiniki)PGH Auditorium

Thu 10:00 - 10:25

GAPP JA in a nutshell

WP2 Leaders: Papageorgiou General Hospital - 7th Health Region of Crete (Prof Dr Papadaki Helen)PGH Auditorium

Thu 10:25 - 10:30

10:30 - 12:30 Towards EU sufficiency, sustainability & cross-sectoral approach

Good Practice Guideline to authorization on preparation process in blood, tissues and cells establishments

WP5 Leaders: Health Products Regulatory Authority (HPRA), Ireland - Organización Catalana de Trasplantes (OCATT), SpainPGH Auditorium

Thu 10:30 - 10:50

Technical annex I: Authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution

WP6 Leader: Agence de la biomédecine (ABM, France)PGH Auditorium

Thu 10:50 - 11:10

Technical Annex II: Assessing the quality and safety of donor testing, pathogen reduction and sterilisation steps as part of Preparation Process Authorisation (PPA)

WP7 Leaders: Agence de la Biomédicine (ABM), France - Laakealan Turvallisuus-JA Kehittamiskeskuss (FIMEA), FinlandPGH Auditorium

Thu 11:10 - 11:30

Technical Annex III: Assessing clinical data as part of PPA authorisation

WP8 Leaders: Laakealan Turvallisuus-JA Kehittamiskeskuss (FIMEA), Finland - Banc de sang i teixits (BST), SpainPGH Auditorium

Thu 11:30 - 11:50

Open Floor Discussion - Q&A

Panel DiscussionPGH Auditorium

Thu 12:00 - 12:30

12:30 - 13:30 Lunch Break

Lunch Break

PGH Restaurant

Restaurant is open daily from 07:30 to 21:30
Thu 12:30 - 13:30
50 max

13:30 - 14:10 Capacity building & Homogenizing the practice across EU

Knowledge sharing on PPA between EU CAs

WP9 Leader: Paul Ehrlich Institut (PEI), GermanyPGH Auditorium

Thu 13:30 - 13:50

Advanced training course on common approaches to PPA in the blood, tissues &; cells, and MAR sectors

WP10 Leader: Krajowe Centrum Bankowania Tkanek I Komorek (KCBTiK), PolandPGH Auditorium

Thu 13:50 - 14:10

14:10 - 14:20 CB Day 1

Coffee Break

PGH Auditorium Foyer

Thu 14:10 - 14:20

14:20 - 15:30 The future of Blood, Tissues & Cells (BTC) in Europe

Integration in national policies and sustainability

WP4 Leader: Istituto Superiore di Sanità (ISS – CNT – CNS), Italy; Registrul National al Donatorilor Voluntari de Celule Stem Hematopoietice, RomaniaPGH Auditorium

Thu 14:20 - 14:40

Evaluation on the achievements and activities of the JA

WP3 Leaders: The Ministry of Human Capacities (Emberi Erőforrások Minisztériuma) CroatiaPGH Auditorium

Thu 14:40 - 15:00

Open Floor Discussion – Q&A

Panel DiscussionPGH Auditorium

Thu 15:00 - 15:30

21st January 2022

GAPP Dissemination Conferrence - Day 2

All times are CET

09:30 - 10:00 European Commission

High level outline of GAPP JA Action – GAPP on Blood, Tissues & Cells

EC (Steffan Van der Spiegel, DG SANTE)PGH Auditorium

EU MS join forces on BTC - Governing principals Approach, Results, Achievements

Fri 09:30 - 10:00

10:00 - 13:00 Call to Action: Policy implementation for BTC recipients in the EU

Bridging the ‘Gap-P’ between science & effective policies - Panel Discussion

Panelists: Marta López Fraga, Scientific Officer at European Directorate for the Quality of Medicines & Healthcare (EDQM) Council of Europe Prof Michel Tsimaratos, Directeur général adjoint chargé de la politique médicale et scientifique à l’Agence de la biomédecine, France Prof Philippe Vandekerckhove CEO, Belgian Red Cross-Flanders Dr. J.C. Wiersum-Osselton, Johanna, GAPP JA External Advisory Board member, TRIP and Sanquin, Netherlands Moderator: Simonetta Pupella MD, Direttore Area Sanitaria e Sistemi Ispettivi (Director Medical Affairs & Blood Inspection System) Centro Nazionale Sangue (National Blood Centre) Istituto Superiore di SanitàPGH Auditorium

Fri 10:00 - 11:15

Current State of Play – Registries - The Role of Associations – Next Steps

Panelists: Prof. Pierre Tiberghien, European Blood Alliance (EBA) President Sofie Terwel, GoCART Project Coordinator European Society for Blood and Marrow Transplantation (EBMT) Executive Office, Department of Biomedical Data Sciences Dr Cristina Magli, Immediate Past Chair, The European Society of Human Reproduction and Embryology (ESHRE) Moderator: Anthi Gafou, Director Hematologist, GAPP JA collaborting partnerPGH Auditorium

Fri 11:30 - 12:15

Patient - Donor safety & effectiveness of treatments: the impact of the revision of BTC legislation - Panel Discussion

Panelists: Prof Elizabeth Macintyre, MD PhD FRCP FRCPath, Onco-hématologie biologique, Necker-Enfants Malades, European Hematology Association (EHA) President Dr Karin Magnussen, IFBDO-FIODS 2014. International Federation of Blood Donor Organizations MEP, TRANSFORM MEP Interest Group (video intervention - tentative) Moderators: Ruth Barrio Ortega, Organització Catalana de Trasplantaments (OCATT); Laura Hickey, Health Products Regulatory Authority (HPRA)PGH Auditorium

Fri 12:15 - 13:00

Coffee Break

PGH Auditorium Foyer

Fri 11:15 - 11:30
50 max

13:00 - 13:30 Closing Remarks

Closing Remarks

Stefaan Van der Spiegel, Head of Sector, Substances of Human Origin, European Commission - DG SANTE | WP1 scientific coordinators: Massimo Cardillo Director General, Italian National Transplant Centre Vincenzo De Angelis, Director General, Italian National Blood CentrePGH Auditorium - ZOOM

Fri 13:00 - 13:30

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We will do our best to answer all your questions.