{"id":9165,"date":"2023-06-21T18:30:23","date_gmt":"2023-06-21T16:30:23","guid":{"rendered":"https:\/\/www.aicro.it\/en\/?p=9165"},"modified":"2023-06-21T18:30:23","modified_gmt":"2023-06-21T16:30:23","slug":"27-06-2023-workshop-implementation-of-the-eu-regulation-on-clinical-trials-in-italy-comparing-experiences-2","status":"publish","type":"post","link":"https:\/\/aicro.it\/en\/27-06-2023-workshop-implementation-of-the-eu-regulation-on-clinical-trials-in-italy-comparing-experiences-2\/","title":{"rendered":"27\/06\/2023 WORKSHOP: IMPLEMENTATION OF THE EU REGULATION ON CLINICAL TRIALS IN ITALY: COMPARING EXPERIENCES"},"content":{"rendered":"

AICRO, in collaboration with the Department of Integrated Activities Research and Innovation (DAIRI) organises the workshop entitled:<\/p>\n

APPLICATION OF THE EU REGULATION ON CLINICAL TRIALS IN ITALY: COMPARING EXPERIENCES<\/strong>
\nTuesday, 27 June 2023<\/strong>
\n10:00 – 13:00<\/strong>
\nRepresentation Hall of the Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo of Alessandria <\/strong>
\nVia Venezia, 16 Alessandria<\/strong>
\n(mixed mode)<\/strong><\/p>\n

RATIONALE<\/strong>
\n📝🔍 The workshop will be entirely dedicated to a discussion on the European Regulation 536\/2014, delving into:
\n✅ Operational experiences and main challenges faced by Clinical Trial Centres, CROs and non-profit developers in the submission process via the CTIS portal
\n✅ Main novelties and critical issues related to contract negotiation timelines
\n✅ In the round table, the preparation of specific centre documents published by the national coordinating centre for Ethics Committees.<\/p>\n

AGENDA<\/strong><\/p>\n

10:00 Introduction and greetings
\nAntonio Maconi, DAIRI Integrated Activities Research and Innovation Department
\nMariagrazia Felisi, CVBF Consortium for Biological and Pharmacological Evaluations<\/p>\n

MODERATOR
\nSerena Penpa, Clinical Trial Centre, DAIRI<\/p>\n

10:15 The role of Clinical Trial Centres in the landscape of Regulation 536\/2014
\nMarta Betti, DAIRI Integrated Activities Research and Innovation Department<\/p>\n

10:40 Use of CTIS, Comparing Experiences Clinical Research Organisations (CROs) and Not-for-profit Promoters
\nIsabel Bestetti, IQVIA Italy
\nRaffaella Ghisini, Clinical Trial Office – European Institute of Oncology (IEO)<\/p>\n

11:20 Contract negotiation timelines, main novelties and critical issues related to the implementation of Regulation 536\/2014
\nMarilena Sciortino, PPD part of ThermoFisher<\/p>\n

11:40 ROUND TABLE
\nComparison on document management in relation to the regulations and indications of the Centre <\/strong>of Coordination of Ethics Committees – Operational aspects<\/strong><\/p>\n

MODERATOR
\nAntoinette van Dijk, MD D.O. Research Sagl<\/p>\n

ATTENDING
\nRaffaella Ghisini, Clinical Trial Office – European Institute of Oncology (IEO)
\nMonica Martignoni, IQVIA Italy
\nIlaria Maruti, Astra Zeneca
\nAlessio Bonardi, Territorial Ethics Committee Liguria
\nAntonella Eliana Sorgente, Gsd Sistemi e Servizi Scarl, member National Coordination Centre for Ethics Committees
\nClaudia Santini, AIFA (TBC)
\nConclusions and greetings<\/p>\n

MODERATORS
\nSerena Penpa, Research Coordinator – Clinical Trial Center DAIRI and Chair subgroup Reg EU\/CTIS GdL Clinical Trial Center AICRO
\nAntoinette van Dijk, Clinical & Medical Affairs Director – MD D.O. Research Sagl and Chair GdL Clinical Trial Center AICRO<\/p>\n

SPEAKERS
\n– Marta Betti, Clinical Research Coordinator – DAIRI Integrated Activities Research and Innovation Department
\n– Isabel Bestetti, Country Site Activation Lead – IQVIA Italy
\n– Alessio Bonardi, Administrative Secretariat Territorial Ethics Committee Liguria – Policlinico S. Martino Hospital – IRCCS
\n-Mariagrazia Felisi, Quality Assurance Head and Internal Auditor – CVBF Consortium for Biological and Pharmacological Evaluations and Co-Chair GdL Cinical Trial Center C AICRO
\n– Raffaella Ghisini, Regulatory Affairs Clinical Trial Office – IEO Scientific Directorate and Member of the Reg EU\/CTIS GdL Clinical Trial Center AICRO subgroup
\n– Antonio Maconi, Director Integrated Activities Research and Innovation Department – DAIRI
\n– Monica Martignoni, Country Site Activation Head – IQVIA Italy
\n– Ilaria Maruti, Site Management & Monitoring Director – Astra Zeneca
\n– Claudia Santini, Health Professional Manager-Biologist – AIFA (TBC)
\n– Marilena Sciortino, Ass. Clinical Manager – PPD part of ThermoFisher and Chair GdL National Contract AICRO
\n– Antonella Eliana Sorgente, General and Legal Affairs Manager Gsd Sistemi e Servizi Scarl, member National Coordination Centre for Ethics Committees<\/h4>\n

📝Download the programme<\/a><\/p>\n

⚙️ Participation is free of charge, after registering at the link: https:\/\/forms.gle\/5Xpd27esEJCe687c8v<\/a><\/p>\n

For information and registration<\/strong>
\nAO SS. Antonio e Biagio e Cesare Arrigo
\nVia Venezia 16 ALESSANDRIA (IT)
\nTel. 0131 206893
\nclinicaltrialcenter@ospedale.al.it<\/a><\/p>\n

Organization offices<\/b>
\nAICRO Associazione Italiana Contract Research Organizations
\nPiazza Meda 3 MILAN (IT)
\nTel. +39 393 3516898
\nsegreteria@aicro.it<\/a><\/p>\n

<\/h4>\n","protected":false},"excerpt":{"rendered":"

AICRO, in collaboration with the Department of Integrated Activities Research and Innovation (DAIRI) organises the workshop entitled: APPLICATION OF THE EU REGULATION ON CLINICAL TRIALS IN ITALY: COMPARING EXPERIENCES Tuesday, 27 June 2023 10:00 – 13:00 Representation Hall of the Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo of … <\/i>Leggi<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9137,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9165","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-senza-categoria"],"yoast_head":"\n27\/06\/2023 WORKSHOP: IMPLEMENTATION OF THE EU REGULATION ON CLINICAL TRIALS IN ITALY: COMPARING EXPERIENCES - Aicro plus<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/aicro.it\/en\/27-06-2023-workshop-implementation-of-the-eu-regulation-on-clinical-trials-in-italy-comparing-experiences-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"27\/06\/2023 WORKSHOP: IMPLEMENTATION OF THE EU REGULATION ON CLINICAL TRIALS IN ITALY: COMPARING EXPERIENCES - Aicro plus\" \/>\n<meta property=\"og:description\" content=\"AICRO, in collaboration with the Department of Integrated Activities Research and Innovation (DAIRI) organises the workshop entitled: APPLICATION OF THE EU REGULATION ON CLINICAL TRIALS IN ITALY: COMPARING EXPERIENCES Tuesday, 27 June 2023 10:00 – 13:00 Representation Hall of the Azienda Ospedaliera SS Antonio e Biagio e C. 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