6th European Conference
on Clinical Research
February 7-8, 2022, Madrid, Spain


For the most updated Programme visit the Online Platform at: www.live.eucrof-conference.eu/programme

Monday 7 February 2022

Opening of the Conference and Key Notes
Chair: Martine Dehlinger-Kremer, EUCROF & ICON Plc, Germany
Time Topic Speaker
08:30 - 09:30 Registration & Welcome Coffee
09:30 – 09:45 Conference Opening Martine Dehlinger-Kremer, EUCROF & ICON Plc, Germany
09:45 – 10:15 The New Regulatory Landscape following the COVID-19 Pandemic Edit Szepessy, European Commission, Belgium
Fergus Sweeney, EMA, The Netherlands
10:15 -10:45 Coffee Break  
Clinical Trial Regulation 536/2014 : Regaining Momentum
Chair: Dagmar Chase
10:45 - 11:15 CTR and its Supportive Documents and Tools - Overview Pieter Van Keerberghen, EMA, The Netherlands
11:15 - 11:45 CTR - a National Competent Authority Perspective Maria Antonia Serrano, AEMPS, Spain
11:45 - 12:15 CTR - an Industry Perspective Pierre Omnes, Syneos Health, France
12:15 - 13:15 Lunch
12:20 - 12:40 World Courier: Satellite Symposium
Technology Innovations in Clinical Research and the COVID-19 Catalyst of Change
Chair: Yvonne Rollinger/Sofoklis Kyriazakos/Fiona Maini
13:15- 13:45 Latest trends on Decentralized Clinical Trials enabled by Digital Health Technologies Isaac Rodriguez Chavez, ICON Plc, USA
13:45 - 14:15 Hyper-accelerate clinical trials using an in silico approach Luca Emili, InSilicoTrials, Italy
14:15 - 14:45 mHealthBelgium: a joint initiative for digital health by government and industry Steven Vandeput, beMedTech, Belgium
14:45 -15:15 Coffee Break  
The New Medical Device Regulation Environment and the Need for Clinical Evidence
Chair: Antoinette van Dijk
15:15 - 15:45 Clinical investigations for conformity assessment purposes and other clinical investigations: what you need to know Monique Al, CCMO, The Netherlands
15:45 - 16:15 Post Market Surveillance and Post Market Clinical Follow Up Plan under EU the MDR Philippe AuclairAbbott, Belgium
16:15 - 16:45 Medical Device Registry as a tool to provide evidence. The experience of Italy in implementing the National registry of implantable prostheses. (RIPI) Marina Torre, Istituto Superiore di Sanità, Italy
The rise of Big Data in pharmacoepidemiology
Chair: Alexandre Malouvier
16:55 - 17:25 Determinants of COVID-19, impact on health care system and vaccination studies using the French national health data system Laura Semenzato, CNAM, France
17:25 End of DAY 1 - Closing Remarks Martine Dehlinger-Kremer, EUCROF & ICON Plc, Germany
18:30 - 22:00 Networking Dinner & Social Event

Tuesday 8 February 2022

An ICH Efficacy Update
Chair: Dagmar Chase
Time Topic Speaker
07:45 - 08:00 Registration & Welcome Coffee
08:00 - 08:30 Modernization of ICH E8 (R1) “General Considerations for Clinical Studies”: From 1997 to 2021 Sigrid Balser, Boehringer Ingelheim, Germany
08:30 - 09:00 Update on ICH E6 (R3) ”Good Clinical Practice” and ICH E19 “Optimisation of Safety Data Collection”  Gabriele Schwarz, BfArM, Germany
09:00 -09:30 Coffee Break  
Patient Centricity, beyond the Concept
Chair: Leyre Malet
09:30 - 09:55 Patient generated health data (PGHD) Rainel Sanchez-de la Rosa, Novartis, Switzerland
09:55 - 10:20 Freely Given Informed Consent: Challenges Elmar Doppelfeld, Association of Medical Ethics Committees, Germany
10:20 - 10:50 Patient Centricity from Theory to Reality
Moderated by Dimitrios Athanasiou

Jorge Mauriño, Roche, Spain
Dimitrios Athanasiou, PDCO, EMA; EURORDIS; European Patient Forum, Greece
Franck Devaux, EC Representative, Belgium

Evolving Roles in a New Clinical Research Era
Chair: Alexandre Malouvier/Benedikt Van Nieuwenhove
11:00 - 11:30 Clinical Trial Liaison: The new Medical Science Liaison: from medical affairs to clinical research Sara Martin Dominguez, ICON Plc, Spain
11:30 - 12:00 Consequences of eSourcing on site performance Maria Teresa García Morales, SCReN, Spain
12:00 - 12:30 Driving the Future Direction of Clinical Operations Guillermo Badenes, Janssen, Spain
12:30 - 13:15 Lunch Break
12:40 - 13:00 Evidenze: Satellite Symposium
Breaking News in Clinical Research
Chair: Benedikt Van Nieuwenhove
13:15- 13:35 The GDPR Code of Conduct:
Good Data Processing Practice for Service Providers in Clinical Research
Yoani Matsakis, Telemedicine Technologies, EUCROF, France
13:35 - 13:55 CRO Landscape Benchmarking in Europe Gert-Jan Dossche, EUCROF, Belgium
Benedikt Van Nieuwenhove, EUCROF, Belgium
13:55- 14:25 The Distributed TMF and the Decommissioning of Computerised Systems Alan Yeomans, Viedoc, EUCROF, Sweden
The Future of Clinical Research
Chair: Antonio Torres
14:25 - 15:10 Panel Discussion, moderated by Doug Peddicord

Doug Peddicord, ACRO, USA
Gabriele Schwarz, BfArM, Germany
Dimitrios Athanasiou, PDCO, EMA; EURORDIS; European Patient Forum, Greece
Rainel Sanchez-de la Rosa, Novartis, Switzerland
Hisashi Uematsu, Japan
Elmar Doppelfeld, Association of Medical Ethics Committees, Germany

15:10-15:15 Closing Remarks Martine Dehlinger-Kremer, EUCROF & ICON Plc, Germany

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