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 Alessandria
Via Venezia, 16 Alessandria
(mixed mode)
RATIONALE
📝🔍 The workshop will be entirely dedicated to a discussion on the European Regulation 536/2014, delving into:
✅ Operational experiences and main challenges faced by Clinical Trial Centres, CROs and non-profit developers in the submission process via the CTIS portal
✅ Main novelties and critical issues related to contract negotiation timelines
✅ In the round table, the preparation of specific centre documents published by the national coordinating centre for Ethics Committees.
AGENDA
10:00 Introduction and greetings
Antonio Maconi, DAIRI Integrated Activities Research and Innovation Department
Mariagrazia Felisi, CVBF Consortium for Biological and Pharmacological Evaluations
MODERATOR
Serena Penpa, Clinical Trial Centre, DAIRI
10:15 The role of Clinical Trial Centres in the landscape of Regulation 536/2014
Marta Betti, DAIRI Integrated Activities Research and Innovation Department
10:40 Use of CTIS, Comparing Experiences Clinical Research Organisations (CROs) and Not-for-profit Promoters
Isabel Bestetti, IQVIA Italy
Raffaella Ghisini, Clinical Trial Office – European Institute of Oncology (IEO)
11:20 Contract negotiation timelines, main novelties and critical issues related to the implementation of Regulation 536/2014
Marilena Sciortino, PPD part of ThermoFisher
11:40 ROUND TABLE
Comparison on document management in relation to the regulations and indications of the Centre of Coordination of Ethics Committees – Operational aspects
MODERATOR
Antoinette van Dijk, MD D.O. Research Sagl
ATTENDING
Raffaella Ghisini, Clinical Trial Office – European Institute of Oncology (IEO)
Monica Martignoni, IQVIA Italy
Ilaria Maruti, Astra Zeneca
Alessio Bonardi, Territorial Ethics Committee Liguria
Antonella Eliana Sorgente, Gsd Sistemi e Servizi Scarl, member National Coordination Centre for Ethics Committees
Claudia Santini, AIFA (TBC)
Conclusions and greetings
MODERATORS
Serena Penpa, Research Coordinator – Clinical Trial Center DAIRI and Chair subgroup Reg EU/CTIS GdL Clinical Trial Center AICRO
Antoinette van Dijk, Clinical & Medical Affairs Director – MD D.O. Research Sagl and Chair GdL Clinical Trial Center AICRO
SPEAKERS
– Marta Betti, Clinical Research Coordinator – DAIRI Integrated Activities Research and Innovation Department
– Isabel Bestetti, Country Site Activation Lead – IQVIA Italy
– Alessio Bonardi, Administrative Secretariat Territorial Ethics Committee Liguria – Policlinico S. Martino Hospital – IRCCS
-Mariagrazia Felisi, Quality Assurance Head and Internal Auditor – CVBF Consortium for Biological and Pharmacological Evaluations and Co-Chair GdL Cinical Trial Center C AICRO
– Raffaella Ghisini, Regulatory Affairs Clinical Trial Office – IEO Scientific Directorate and Member of the Reg EU/CTIS GdL Clinical Trial Center AICRO subgroup
– Antonio Maconi, Director Integrated Activities Research and Innovation Department – DAIRI
– Monica Martignoni, Country Site Activation Head – IQVIA Italy
– Ilaria Maruti, Site Management & Monitoring Director – Astra Zeneca
– Claudia Santini, Health Professional Manager-Biologist – AIFA (TBC)
– Marilena Sciortino, Ass. Clinical Manager – PPD part of ThermoFisher and Chair GdL National Contract AICRO
– Antonella Eliana Sorgente, General and Legal Affairs Manager Gsd Sistemi e Servizi Scarl, member National Coordination Centre for Ethics Committees
⚙️ Participation is free of charge, after registering at the link: https://forms.gle/5Xpd27esEJCe687c8v
For information and registration
AO SS. Antonio e Biagio e Cesare Arrigo
Via Venezia 16 ALESSANDRIA (IT)
Tel. 0131 206893
clinicaltrialcenter@ospedale.al.it
Organization offices
AICRO Associazione Italiana Contract Research Organizations
Piazza Meda 3 MILAN (IT)
Tel. +39 393 3516898
segreteria@aicro.it
