• • WHO Global Consultation on Vigilance and Surveillance for Medical Products of Human Origin , 7-9 511fl:W 2556 tu . 2. • IVl n U6'l:::V11.Jl 1'U , the Agencia Nacional de Vigilancia Sanitaria (ANVISA), the WHO Country , Office in Brasilia, the WHO Regional Office for the Americas uae the Pan American Health Organization (PAHO) lan 1V1n.! bb6'l::: ""'<l. I .. V q iI .d oQo d "iJ1 1 'iA6'l1 u 'WYll'J b"1JV1'lJ1qj"iJ1nat:l1'Uu'Ufn'.iPl il.:lFln'Jl"l11"l1Yi uesain V1:::m'lt: Yl'U"iJ1 nVl1.J1 rua'lJ'1J " " , 80 fl'U"iJ1n 30 3. tJ'J:::51'U Or. Daniel R. Coradi de Freitas The National Health Surveillance Agency '" .. 0 .. d. I d. I (AgEmcia Nacional de Vigilancia Sanitaria, ANVISA) m51'.iru!U'.i1"'1l6'l 'Vl1V1'U1Ylu'.i:::51'U'Vl 4. , , '" (\11u un , . 3 Bologna Initiative for Global Vigilance and Surveillance (the BIG V&S) 63 (WHA 63.22) " L'"ll6'l Im.:lnwOd:J'Ufl11:w11:wiitl , . .. "'1 1/ eNflnT'jtl'U1lJEJ an Lbo::; the Italian National Transplant Centre (CNT) , bLm :: B1'U1 l'J A11lJi:1 ::m n1 HiL'"ll6'l " , (Medical Product of Human Origin, MPHO) The Notify Library .,. '" lJ 3 U m'J 1lI '" '\ , U1ba'UtlA11:wa1rlqj The Notify Library m'.ibDVl(i11 The Notify Library
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• •
b~B~ WHO Global Consultation on Vigilance and Surveillance for
L.-JL r-timsterto da• I, ANVISASUS.. • SaudeAgencia Naclonal de Vigilancla Sanil<i ri,l • P AI S R I CO E P A i S SEI1 P O DREZA
()T I FY Cent ro Nazionale Trap iam i
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
I I
I
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