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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 Auclair, Abbott, 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 |
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| 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 |
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|---|---|---|
| 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 |
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| 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 |
| Evolving Roles in a New Clinical Research Era Chair: Alexandre Malouvier/Benedikt Van Nieuwenhove |
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| 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 |
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| 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 |
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| 14:25 - 15:10 | Panel Discussion, moderated by Doug Peddicord |
Doug Peddicord, ACRO, USA |
| 15:10-15:15 | Closing Remarks | Martine Dehlinger-Kremer, EUCROF & ICON Plc, Germany |