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8:30 |
Registration | |
| 9:00 - 10:00 | Exhibition Opening & Welcome Coffee | |
| Room: Olympia Mancini 2 | ||
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Opening of the Conference Chair: Dr. Martine Dehlinger-Kremer, EUCROF President; Vice President, Global Scientific and Medical Affairs, Synteract, Germany |
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| Time | Topic | Speaker |
| 10:00 - 10:15 | Conference Opening, Welcome Message from the EUCROF president. |
Dr. Martine Dehlinger-Kremer, EUCROF President; Vice President, Global Scientific and Medical Affairs, Synteract, Germany |
| 10:15 - 11:00 | How Did This Happen? - A Fresh Look at Health Care | Dr. Peter Kapitein, h.c., Patient advocate at Inspire2Live, The Netherlands |
| Room: Olympia Mancini 2 | ||
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Clinical Trials Regulation (EU) No 536/2014 Chair: Dr. Dagmar Chase, Managing Director Clinrex GmbH, Germany. Co-Chair: Dr. Ulrike Lorch, Co-Founder and Medical Director, Richmond Pharmacology Limited, UK. |
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| 11:05 - 11:30 | European Clinical Trials Regulation (CTR): Status Quo. | Anabela Marcal, Head of Committees and Inspections Department, Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency (EMA), UK |
| 11:30 - 11:55 | Clinical Trials Regulation (EU) No 536/2014 – Any Pitfalls for Industry? | Sini Eskola, Director, Regulatory, Drug Development and Manufacturing, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium |
| 11:55 - 12:20 | What will change for Investigator Initiated Trials (ITTs)? | Prof. Dr. Heiko von der Leyen, CEO, Hannover Clinical Trial Center GmbH (HCTC), Germany |
| 12:20 - 12:45 | How will Ethic Committees be impacted by the EU Clinical Trials Regulation? | Prof.Dr. Joerg Hasford, Institute for Medical Informatics, Biometry, and Epidemiology (IBE), LMU Munich; Chair of the Working Group of the German Ethics Committees, Germany |
| 12:45 - 13:00 | Discussion | All |
| 13:00 - 14:00 | Lunch Break & B2B Meetings | |
| Room: Olympia Mancini 2 | ||
| 14:00 - 14:30 | Gold Partner´s Lecture: Latest Geographic Trends in Global Industry Clinical Trials: Who is Winning, Who is Losing | Vladimir Misik, MSc. PhD, Member of the Board, SanaClis s.r.o.; Managing Partner Longtaal s.r.o., Slovakia |
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Good Clinical Practice, the new addendum E6 (R2), Part 1: Risk Based Quality Management Chair: Dr. Michèle Garot, Managing Director CLINcellence, Belgium. |
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| Time | Topic | Speaker |
| 14:30 - 15:00 | Risk-Based Monitoring: Where are we in 2018? An Inspector‘s Experience | Gabriele Schwarz, Head of GCP Inspectorate, Federal Institute for Drugs and Medical Devices, BfArM, Germany. |
| 15:00 - 15:30 | The Good, the Bad and the Site in Risk Based Monitoring, the sites’ perspective over the years. |
Dr. Vivienne van de Walle, MD, Ph.D., CPI, Director PT&R, Member of the Leadership Council the Society of Clinical Research sites (SCRS), The Netherlands |
| 15:30 - 16:00 | Risk-Based Monitoring Implementation: A Sponsor’s Perspective | Mag. Claudia Kriebaum, Manager, Risk Based Monitoring, Eli Lilly, Regional Operations GmbH; Austria. |
| 16:00 - 16:30 | Computerized Clinical Trials? A modern way to gain quality in study design and optimise drug development. | Francois-Henri Boissel, MSc, CEO Novadiscovery, France. |
| 16:30 - 17:00 | Coffee Break | |
| Room: Olympia Mancini 2 | ||
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Part 2: Operating Models further re-enforced by new regulations & guidelines Chair: Yoanni Th. Matsakis, President Telemedicine Technologies S.A.S., France. |
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| 17:00 - 17:30 | Inspection findings from eTMF implementations. | Andy Fisher, Senior GCP Inspector, GCP Inspectorate, MHRA, UK. |
| 17:30 - 18:00 | General Data Protection Regulation (GDPR) & big data in the healthcare sector: How to draw value for patients and companies out of the new EU framework and its challenges? |
Cécilia Alvarez, European Data Protection Officer Lead, Pfizer, Spain. Cécile Théard-Jallu, Partner Attorney, De Gaulle Fleurance & Associés, France. |
| 18:00 - 18:30 | Investigator Site eSource Readiness Assessment Tool (eSRA): Is your EHR system suitable for originating records that will be used in regulated clinical trials? |
Dr. Yvonne Rollinger, Managing Director, Omnicomm Europe, Representative of the eClinical Forum eSRA Initiative, Germany |
| 20:00 | Networking Dinner in the Hotel Savoyen, Vienna | |
| 1st Parallel Sessions | ||||
| Room: Olympia Mancini 1 | Room: Olympia Mancini 2 | |||
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GCP compliance of e-Systems and Technical Solutions Chair: Alan Yeomans, Quality Manager, PCG Solutions, Co-chair of the eClinical Forum Regulatory Expert Group, Co-chair of the EUCROF Working Group New Technologies, Sweden. |
Clinical Trials in the Paediatric Population Chair: Dr. Martine Dehlinger-Kremer, EUCROF President; Vice President, Global Scientific and Medical Affairs, Synteract, Chair of the EUCROF Paediatric Working Group, Germany Co-chair: Dr. Georg Mathis, CEO Appletree CI Group AG, Switzerland. |
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| Time | Topic | Speaker | Topic | Speaker |
| 8:30 - 9:00 | What makes a good audit trail dataset? | Andy Fisher, Senior GCP Inspector, GCP inspectorate, MHRA, UK | The Paediatric Regulation revision/update. |
Dr. Marek Migdal, MD, PhD, Deputy Head of Children’s Memorial Health Institute, Member EMA Paediatric Committee (PDCO), Poland |
| 9:00 - 9:30 | Contractual requirements on the responsibilities of e-Systems Vendors with regards to GCP. | Wolfgang Summa, Head of Clinical Applications and Technologies, Merck Group, Germany | Pan-European Paediatric Clinical Trials Network |
Dr. Mark Turner, Institute of Translational Medicine, University of Liverpool, Chair European Network of Paediatric Research at EMA, United Kingdom. |
| 9:30 - 10:00 | Risk based validation and Agile development. | Jesper Rosendal, Senior Manager Corporate Quality Assurance IT, Lundbeck, Denmark. | Set up of a Network for Paediatric Clinical Trials. The Italian Example | Francesca Rocchi, PharmD, MSc.; INCIPIT – Italian Network for Paediatric Clinical Trials, Academic Department of Pediatrics, IRCCS Bambino Gesù Children Hospital, Italy |
| 10:00 - 10:30 | Panel Discussion. | All | Patient involvement in paediatric clinical research. | Claas Röhl, Founder NF Children, Chair Austrian EUPATI platform; EUPATI fellow, Austria |
| 10:30 - 11:00 | Coffee Break | |||
| 2nd Parallel Sessions | ||||
| Room: Olympia Mancini 1 | Room: Olympia Mancini 2 | |||
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European Medical Device Regulations Chair: Dr. Antoinette van Dijk, Scientific Director AICRO, Italian association of CROs, Co-chair of the EUCROF Working Group Medical Devices, Italy |
New European Data Privacy Regulation Chair: Isabelle Abousahl, President Alcoam by design SAS; Member of the EUCROF Working Group New Technologies, France Co-chair: Thierry Lepoutre, Managing Director, Lambda Plus, Member of the EUCROF New Technologies Working Group, Belgium |
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| Time | Topic | Speaker | Topic | Speaker |
| 11:00 - 11:30 | Highlights and Challenges of the EU Medical Device Regulations. | Stefan Menzl, PhD, Principal Consultant Regulatory Affairs, Qserve Group,The Netherlands | Data Protection and Clinical Trial Agreements, seen through the eyes of a trial site. | Markus Kastelitz, Data Protection Officer,(formerly) Medical University of Vienna, Austria |
| 11:30 - 12:00 | MDR Impact Assessment for Manufacturers. | Luca Orlandini MD, Vice President Global Medical Affairs, Smith & Nephew Orthopaedics AG, Switzerland | How to comply with the GDPR in a global and innovative environment? | Sarah Taïeb, Global Data Privacy Manager, IPSEN, France |
| 12:00 - 12:30 | Clinical Evaluation according to MEDDEV 2.7/1 revision 4 and Medical Device Regulation. | Carolina Gualtieri, Member Medical Device Group SSFA, Fondazione Policlinico Gemelli, Italy | PhUSE Data Transparency Working Group: Providing De‑identification Standards to CDISC Data Models |
Jean-Marc Ferran, Consultant & Owner, Qualiance; Data Transparency Working Group Lead, PhUSE; Denmark |
| 12:30 - 13:30 | Lunch Break & B2B Meetings | |||
| Room: Olympia Mancini 2 | ||||
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Peri and post-approval research environment in 2020: Boldly shaping the future while not going overboard of this shaken ship Chair: Xavier Fournie, M.D., Corporate Medical Director, Executive Vice-President, Global Medical Affairs – Real World Evidence, Mapi –ICON plc, Co-chair of the EUCROF PharmacoVigilance Working Group, France. |
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| 13:30 - 14:00 | Real World data in observational research: myth or reality? | Dr. Vasa Curcin, PhD, MSc(Imp), BSc(Hons), Senior Lecturer in Health Informatics, Faculty of Life Sciences & Medicine, King’s College London, UK | ||
| 14:00 - 14:30 | Adaptive Pathways, Post-Authorisation Efficacy Studies, Health Technology Assessment needs... Are we going to finally see the development of pragmatic/ low-intervention trials in the near future? | Dr Patrice Verpillat, M.D., MPH, PhD, Head of Global Epidemiology, Merck KGaA / EFPIA observer at ENCePP Steering Committee, Darmstadt, Germany | ||
| 14:30 - 15:00 | Engagement and impact of patients in (peri-and post-approval) clinical research; why, what, how? Some considerations and learning points | Dr. Eric Roos, Ph.D, Board Member Dutch Clinical Research Foundation / Chairman Dutch Parkinson’s Association, University of Amsterdam, The Netherlands | ||
| 15:00 - 15:30 | Transparency and scientific independence throughout the post-authorisation research process; the ENCePP/EMA Code of Conduct. |
Dr Rosa Gini, PhD, Head of Pharmacoepidemiology Unit Agenzia Regionale di Sanità della Toscana (ARS), Member of ENCePP Steering Group and ENCePP Working Group 2 “Independence and Transparency”, Italy |
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| Room: Olympia Mancini 2 | ||||
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European Union redesigned Introduced by Dr. Martine Dehlinger-Kremer, EUCROF President; Vice President, Global Scientific and Medical Affairs, Synteract, Germany. |
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| 15:30 - 16:00 | Brexit: Everything that you want (& need?) to know! | Dr. Virginia Acha, Executive Director - Global Regulatory Policy, MSD R&D Innovation Centre, Research Medical and Innovation, Association of the British Pharmaceutical Industry (ABPI), London, UK | ||
| 16:00 - 16:10 | Conference Closure, Good Bye message from the EUCROF president |
Dr. Martine Dehlinger-Kremer, EUCROF President; Vice President, Global Scientific and Medical Affairs, Synteract, Germany. |
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| 16:10 - 17:00 | Good-bye coffee | |||