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WHO Global Consultation on Vigilance and Surveillance for Medical Products of Human Origin

Draft programme of Work v6.0

7-9 December 2013

Brasilia - DF- Brazil

Saturday 7 December 13:30 - 14:00 Coffee - Registration

Introduction

14:00 Welcome and Introduction of participants - Election of Chair and Rapporteurs

14:15 Global V&S and the WHO initiative for Medical Products of Human Origin Luc Noel

14:30 V&S a driver for excellence in transplantation. eNT and European experience Alessandro Nanni­Costa

14:45 The focus of ANVISA on V&S : the example of Medical Products of Geni Neumann Human Origin

15 :00 Agenda and objectives of the third consultation Deirdre Fehily

15:30· 16:00 CoffeeBreak

The NVl'l1·Y Library: Review and Resolution ofremarkable cases Achievements Updates and orientations for the future 16:00 Editorial Group Workshops

Infections Malignancy Editorial Group Edilorial Group MeeliDgRoom Meeting Room

Chalr Chair Paolo Grossi Bealriz Dominguez

Process Editori"l GrOUI' Meeting Room

Chair Marian Macsai

Living Donor Editorial Group Meeting Room

Chair Daniel Roberto Coradi

de freitas

Genetic Edllorl.1Group M~ ~ l1 o gRno m

Transfusion MeellngRoom

Chair Chair Laura saint Martin Neelam Dhingra-Kumar

To work through unresolved rows agreeing to solutio ns

18:30 Adjourn

Sunday 8 December

08:30 -9:00 Coffee

Reports of the Editorial workgroups

09:00

09 :15

09:45

10:15

Introduction and facilitation

Infection - presentation + cases discussion

Malignancy - presentation + cases discussion

Process - presentation + cases discussion

Mike Strong

Paolo Grossi

Beatriz Dominguez

Ma ria n Macsa i

10:45 -11 :15 CoffeeBreak

11:15

11:45

12:15

12 :35

Living donor - presentation + cases discussion

Genetic ­ presentation + cases discussion

New scope with the extension to blood

General discussion

Daniel Roberto Coradi de Freitas

Laura Saint Martin

Giuliano Grazzini

13:00 . 14:00 Lunch

Specificities and priorities by type ofMPHO

14:00 Breakout groups

Organs MeeliJ>gRoom

Cells Meeting Room

Tissues Meeling Room

ART Meeliog Roo,/,

i Blood

Meeting Room

Chair PhilO'Connel

Chair AdrianSeber Chair

Ted Easllund Chair ~

ChrisO'Tool'e \

Chalr Giuliano Grazzini

15:00 Report in plenary )15.30 General dISCUSSIOn

15:45 -16:00 Coffee Break

Future developments of the NOTIFY Library /

16:00 How to better capture, classify and use didactic adverse Stratos Chatzixiros events in the NOTIFY Library

16:40 Presentation of an electronic tool for the insertion of new Dan iela Minutoli case types, or new information on existing case types (end Deirdre Fehily of Google docst)

17 :00 Towards using the NOTIFY Library as a medium of publication Mike Strong

17:20 Terminology for V&S of MPHO constraints and ne cessities Geni Neumann Paul Ashford Evi Petrisli

17 :50 A place for ethics in the NOTIfY Library'! Marie-Cha rlotte Bouesseau

18:10 General discussion

18:30 Adjourn

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Monday 9 December

08:30 -9:00 Coffee

09:00 - 09:15 Summary by Rapporteurs

Official launch ofthe NOTIFY website and library

09:15 ANVlSA, CNT, ISS, WHO PAllO, WHO HQ, MOH Brazil

10:00 Language specific interfaces for the NOTIFY Library and website lose Nunez

10:20 General Discussion

10:40 - 11:10 CoffeeBreak

Promoting reporting systems and disseminating outcomes

11: 10 Round table: National V&S systems, lessons learnt, impact on practices and perspectives

12:00 Round table : The roles of scientific and professional associations in V&S as support and complement of National V&S systems

12:40 Update on the EUvigilance tools Ioana Siska

13:00 Lunch

Global tools for the V&sofMPHa 14:00 The links of vigilance for MPHO Luc Noel

14:15

14:30

Horizon scanning, a role for a network of CDCs ?

Gcncral discussion: priorities for Global vigilance

Matt Kuehnert, Drago Domanovic

Conclusions and the way forward

15:30 Conclusions and the way forward Chair

16:00 Meeting close