Celebration of International Clinical Trials Day May 2016 Preliminary Agenda

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1 Celebration of International Clinical Trials Day May 2016 Preliminary Agenda Conference and Social Centre "House for Professed", Malostranské náměstí 2/25, Praha 1 ECRIN and CZECRIN Meeting This meeting precedes ECRIN's celebration of International Clinical Trials Day 2016, to be held on 20 May Designed primarily as an internal meeting, it will include two joint sessions with Czech stakeholders (policymakers, academics, etc.). The groups will start the meeting together, separate before lunch, share lunch, and reconvene at the end of the day (17:00) for a final joint discussion. Time Description Who 11:00 11:30 Coffee/Registration Joint ECRIN and CZECRIN meeting 11:30 11:35 Welcome address 11:35 11:50 Introduction to ECRIN Speaker: Christian Ohmann (Chair of Network Committee, ECRIN) Speaker: Jacques Demotes 11:50 12:20 Presentation of selected projects and activities TBD ECRIN and CZECRIN parallel meetings CZECRIN Meeting (in Czech) 12:30 13:30 - Academia, SÚKL, AIFP presentation 13:00 14:00 Common lunch 14:00 15:15 - Representative of the Faculty Hospitals 15:15 15:45 Coffee

2 15:45 17:00 - Presentation of selected academic clinical trials (Investigator-Initiated Trials) ECRIN internal meeting 12:20 12:35 Who s who: Presentation of ECRIN team 12:35 13:00 13:00 14:00 Common lunch 14:00 15:15 15:15 15:45 Coffee Implementation of 2016 work plan Key components of the strategic plan ( ) Presentation of ECRIN workflow Working groups: - Preparation: ECRIN support from idea conception to submission of funding applications - Initial implementation: support during project launch - Continued implementation / management: ECRIN support throughout the clinical trial up until publication Core Team and European Correspondents Speaker: Jacques Demotes Facilitators TBD (two Core Team members per working group) 15:45 16:45 16:45 17:00 Presentation of working group findings / recommendations and discussion Presentation: How communications can support ECRIN's organisational goals. Discussion. TBD Sabrina Gaber (Communication Officer, ECRIN) Joint session 17:00 17:55 17:55 18:00 Conclusion Discussion between ECRIN and Czech stakeholders Jacques Demotes Social networking event 20:00 24:00 Boat trip with dinner and live music Free for registered participants

3 Senate of the Parliament of the Czech Republic, Valdštejnské náměstí 17/4, Gate C2, Praha 1 International Clinical Trials Day 2016 ECRIN Clinical trials in the era of personalised medicine held under the auspices of Milan Štěch, the President of the Senate of the Parliament of the Czech Republic With cooperation of the COMMITTEE ON HEALTH AND SOCIAL POLICY, ECRIN ERIC and CZECRIN Time Description Who 8:00 8:30 Coffee/Registration ECRIN and medical research infrastructures in the Czech Republic and Europe 8:30 8:40 Welcome address 8:40 8:50 Research infrastructures in the Czech Republic Co-Chairs: Rostislav Vyzula, Chairman of the Committee on Health Care Chamber of Deputies Parliament of the Czech republic, Regina Demlova, CZECRIN, Masaryk Univerzity (Brno, Czech Republic), Marian Hajduch, Director of BioMedReg (Olomouc, Czech Republic) Jan Zaloudik, Chairman of the Committee on Health and Social Policy Senate of the Parliament of the Czech Republic Robert Plaga, Deputy Minister, Czech Ministry of Education, Youth and Sports (Prague, Czech Republic) 8:50 9:00 Clinical Trials as a part of Clinical Research in the Czech Republic Tom Philipp, Deputy Minister, Czech Ministry of Health 9:00 9:05 Discussion 9:05 9:15 Introduction to ECRIN, the instrument for multinational trials in Europe Jacques Demotes, Director General, ECRIN (Paris, France) 9:15 9:25 CZECRIN as the Czech national part of ECRIN Regina Demlova, Head of Pharmacology, Masaryk University Faculty of Medicine (Brno, Czech Republic) 9:25 9:30 Discussion 9:30 9:40 Academic clinical trials and New EU clinical Representative of the Czech State

4 9:40 9:55 trials Regulation Clinical part of ESFRI infrastructures: current issues and future challenges Institute for Drug Control (SUKL) (TBD) Dalibor Valik, Masaryk Memorial Cancer Institute/RECAMO Executive Director (Brno, Czech Republic) 9:55 10:10 Discussion 10:10 10:40 Coffee 10:40 11:00 11:05 11:25 11:30 11:50 11:55 12:15 Personalised medicine: definition, case study What is personalised medicine? Use and meaning of the term Personalised medicine and evidence-based medicine Development of personalised medicine within child oncology: a case study Personalised medicine: methodological, ethical and regulatory aspects Methodological aspects and challenges of personalised medicine Co-chairs: Silvio Garattini, Director, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS (Milan, Italy) (TBC) and Christian Gluud, Head of Anna Pokorska-Bocci (TBD), Associate, PHG Foundation (Cambridge, UK) Dhavendra Kumar, Consultant in clinical genetics, Institute of Cancer & Genetics, Cardiff University School of Medicine (Cardiff, UK) Norbert Graf, Professor of paediatrics and Head of Paediatric oncology, Saarland University (Hamburg, Germany) Co-chairs: Jaroslav Sterba, Vice- Dean Faculty of Medicine, Masaryk Univerzity (Brno, Czech Republic) and Christian Gluud, Head of department, Copenhagen Trial Ian Roberts (TBC), Professor of epidemiology and public health and co-director of the Clinical Trials Unit at the London School of Hygiene & Tropical Medicine (London, UK) 12:20 12:40 Ethical aspects of personalised medicine Michelle McGowan, Associate professor of bioethics and sexuality studies, Pennsylvania State University (PA, USA) 12:45 13:05 Regulatory challenges and views on personalised medicine Marisa Papaluca, Senior scientific advisor, European Medicines

5 Agency (London, UK) 13:10 14:10 Lunch 14:10 14:30 14:35 14:55 15:00 15:20 15:25 15:45 Personalised medicine: scientific, industry and patient s Personalised medicine from a scientific Personalised medicine from an industry Personalised medicine from a multi-stakeholder Panel discussion What is the future of clinical trials and evidencebased medicine in the era of personalised medicine? Co-chairs: Gonzalo Calvo, Consultant in clinical pharmacology, Hospital Clinic (Barcelona, Spain) (TBC) and Christian Gluud, Head of Angela Brand, Director European Centre for Public Health Genomics (Maastricht, The Netherlands) Magda Chlebus, Director of science policy at the European Federation of Pharmaceutical Industries and Associations (EFPIA) (TBC) Denis Horgan, Executive Director, European Alliance for Personalised Medicine (Brussels, Belgium) Chair: Christian Gluud, Head of All chairs and speakers 15:45 15:50 Conclusions Jacques Demotes, Director General, ECRIN (Paris, France)

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