Monday, 25 March 2019

15,00 Inizio lavori
18,30 visita guidata in inglese alla Pietà Rondanini
19,30 Social Dinner

Martedì 26 marzo


Panel 1
Status of EU and national legislation in view of the application (if and when) of Regulation 536/2014; impact of related Regulations, particularly GDPR
Dr. Liliana Burzilleri (Regione Lombardia)
Dr. Felice Lopane (Assolombarda)
Avv. Deborah Bolco (Pavia e Ansaldo) on GDPR aspects


Panel 2
Pprofit and non-profit approach in clinical trials in the new (Regulation or not) European environment, in the context of a continuing technological innovation (e.g. genetic “side” studies, innovative therapies such as e.g. CAR-T, reimbursement issues and compassionate use): the specific Italian situation of a public, taxpayer-funded, universalistic National/regional Healthcare Service
Prof. Andrea Biondi (Università Milano-Bicocca)
Avv. Fausto Massimino (Roche)
Dr. Michele Tedeschi (Humanitas)


Panel 3
“Co-existence of medicines and devices in trials” (MDR and differences in legislation at the EU and national level), in the context of a continuing technological innovation (e.g. Big Data – the new oil! – issues and application of AI; predictive and companion diagnostics; ethic considerations as guideline in situations becoming extremely complex – for technological as well as economic reasons (including public/social costs)
Avv. Riccardo Jerinò, Gilead Sciences

12,30 Conclusione lavori e wrap-up a cura dei coordinatori del gruppo, Cathérine Longeval e Agostino Migone De Amicis
13,00 Light lunch