ECRIN-TWG kick-off meeting Tenerife, October 31, 2006 01/12/2006 - PowerPoint PPT Presentation

ECRIN-TWG kick-off meeting Tenerife, October 31, 2006 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 1

Other regions Canada Sweden SweCRIN Denmark Ireland DCRIN EFGCP ICRIN UK UK-CRN EORTC and Germany other EU countries KKS Aus, Bel, NL… France Hungary CIC & UEC HECRIN Spain Italy SCReN IRFMN & CIRM National networks of Clinical Research Centres / Clinical Trial Units 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 2

ECRIN, an integrated integrated infrastructure infrastructure ECRIN, an for clinical clinical trials in trials in the the EU EU for � ECRIN � ECRIN- -1 (2004 1 (2004- -2005) : 2005) : – Identifying Identifying bottlenecks bottlenecks – � ECRIN ECRIN- -2 (2006 2 (2006- -2008) : 2008) : � – – Preparing Preparing the the infrastructure infrastructure � ECRIN � ECRIN- -3 (2008 3 (2008 - -> ) : FP7 ESFRI > ) : FP7 ESFRI roadmap roadmap – Preparation Preparation, construction , construction and and operation operation of of the the infrastructure infrastructure – supporting multinational supporting multinational clinical clinical trials in trials in the the EU EU � In line � In line with with expectations of FP7 expectations of FP7 ‘ ‘Innovative Innovative Medicines Medicines Initiative Initiative 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 3

ECRIN- -1 (2004 1 (2004- -2005) : 2005) : ECRIN identifying bottlenecks bottlenecks identifying ECRIN-RKP (FP6-funded): -> survey and comparative analysis on 1 - Structures and objectives of centres and networks 2 - Financing, sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, insurance 5 – Adverse event reporting, drug dispensing 6 – Methodology, data management, data monitoring 7 - Quality management, SOPs, audits 8 - Communication, partnerships 9 - Study registers 10 – Education and careers -> reports on www.ecrin.org 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 4

ECRIN- -2 (2006 2 (2006- -2008) : 2008) : ECRIN preparing the the infrastructure infrastructure preparing ECRIN TWG (FP6- -funded) funded) ECRIN TWG (FP6 TRANSNATIONAL WORKING GROUPS : TRANSNATIONAL WORKING GROUPS : -> Guidelines > Guidelines and and procedures procedures - 1 - - ethics ethics 1 2 - - regulation regulation 2 3 - - adverse adverse event event reporting reporting 3 4 - - data management data management 4 5 - 5 - monitoring monitoring – SOPs 6 - - quality quality assurance assurance – SOPs 6 7 - - education education 7 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 5

MANAGEMENT Advisory Board Network Committee Working Parties Co-ordination team Ethics-regulation-vigilance Ch. Kubiak J. Demotes Data managt & monitoring Quality assurance European European European European Correspondent Correspondent Correspondent Correspondent National National National National Network Network Network Network 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 6

CR CR Ce n t r e Cent r e CR CR CR Cent r e Cen t r e CR Cent r e CR Cent r e CR Co o r d i n at i o n Co o r d i n at i o n Cent r e CR n at i o n al n at i o n al Ce n t r e n e t w o r k n e t w o r k CR CR Cen t r e Cent r e ECR I N RC Cen t r e RC Cent r e Co o r d i n at i o n RC Co o r d i n at i o n n at ion al Cent r e n at i o n al n et w o r k R C n e t w o r k Cent r e RC RC RC Cent r e Cent r e Cent r e RC Co o r d i n at i o n Cen t r e RC R C RC n at i o n al Cen t r e Cent r e Ce n t r e RC n e t w o r k Cen t r e RC RC Cent r e Cen t r e RC Cent r e CR = Clin ical Resear ch 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 7

ECRIN Advisory Board ECRIN Advisory Board - European stakeholders and regulators European stakeholders and regulators � - � 1 - - Representative of the Commission / IMI Representative of the Commission / IMI 1 � 2 - 2 - Representative of European Medicines Agency (EMEA) Representative of European Medicines Agency (EMEA) � 3 – – Representative of the Clinical Trials Facilitation Team Representative of the Clinical Trials Facilitation Team 3 - Users and partners Users and partners � - I ndustry: � I ndustry: � 4 - 4 - European Federation of Pharmaceutical Industries and Associatio European Federation of Pharmaceutical Industries and Associations ns (EFPIA)/IMI (EFPIA)/IMI � 5 – – EuropaBio EuropaBio (representing the biotechnology SME sector) (representing the biotechnology SME sector) 5 � Public sponsors and scientific agencies: Public sponsors and scientific agencies: � 6 - - European Science Foundation (ESF) European Science Foundation (ESF) 6 � 7 - - Europe & Developing Countries Clinical Trials Programme (EDCTP) Europe & Developing Countries Clinical Trials Programme (EDCTP) 7 Scientific associations and networks: � Scientific associations and networks: � 8 - 8 - Paediatrics: representative of the TEDDY Paediatric network of Paediatrics: representative of the TEDDY Paediatric network of excellence excellence � 9 - 9 - European Organisation for Research and Treatment of Cancer (EOR European Organisation for Research and Treatment of Cancer (EORTC) TC) � Patients’ Patients ’ associations: associations: � 10 - - European AIDS Treatment Group (EATG) European AIDS Treatment Group (EATG) 10 � 11 - - European Association for Rare Diseases (EURORDIS) European Association for Rare Diseases (EURORDIS) 11 � Partner in communication: Partner in communication: � 12 - - Orphanet Orphanet 12 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 8

Network committee committee Network � Denmark � Denmark : :Ch Ch Gluud Gluud � France : G Chêne, J France : G Chêne, J Demotes Demotes � � Germany � Germany : : Ch Ch Ohmann Ohmann � Hungary � Hungary : C : C Farsang Farsang � Ireland : P Ireland : P Meulien Meulien � � Italy � Italy : S : S Garattini Garattini, N , N Fabris Fabris � Spain Spain : X Carn : X Carné é � � Sweden � Sweden : P : P Lafolie Lafolie � United United Kingdom Kingdom : P : P Selby Selby � � Canada : JP Collet Canada : JP Collet � � EFGCP : JP � EFGCP : JP Tassignon Tassignon � EORTC ? EORTC ? � � Meetings Meetings and and teleconferences teleconferences � � Vote ( � Vote (including including for extension, budget, for extension, budget, amendments amendments) ) 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 9

ECRIN- -2 (2006 2 (2006- -2008) : 2008) : ECRIN 7 working working groups groups 7 1 - 1 - ethics ethics 2 - - regulation regulation 2 3 - 3 - adverse adverse event event reporting reporting 4 - - data management data management 4 – monitoring 5 – 5 monitoring – SOPs 6 - - quality quality assurance assurance – SOPs 6 7 – – education education 7 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 10 10

ECRIN working party members ECRIN working party members � Two per country, one responsible for the � Two per country, one responsible for the deliverables, supported by a substitute. The deliverables, supported by a substitute. The European Correspondent participates in every European Correspondent participates in every working party. working party. � Additional input for the industry, regulators, Additional input for the industry, regulators, � ethics committees, partner organisations organisations ethics committees, partner (EFGCP, EORTC), and from the paediatric (EFGCP, EORTC), and from the paediatric field field 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 11 11

ECRIN- -2 : deliverables 2 : deliverables ECRIN Guidelines and procedures for multinational Guidelines and procedures for multinational studies, posted on the internal internal website, website, studies, posted on the and updated. and updated. � Clinical studies on medicinal products : � Clinical studies on medicinal products : sept 2006 sept 2006 - -> > june june 2007 2007 � Other clinical research : � Other clinical research : - -> > june june 2008 2008 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 12 12

ECRIN TWG budget ECRIN TWG budget 700.000 € over 2 years, start date October 1st 2006 - 80% in december 2006 (45 days after signature of the contract) - 20% 45 days after final scientific and financial report Follow-up of expenses by the coordination with the support of EU correspondents One single audit certificate at the end of the project Expenses should fit with the financial plan, however changes are allowed if justified For AC cost models, salaries should correspond to personnel specifically hired for the project. 01/12/2006 01/12/2006 www.ecrin.org www.ecrin.org 13 13