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Opening of the Conference Chair: Dr. Martine Dehlinger-Kremer, President EUCROF, Vice-President, Global Medical and Regulatory Affairs, SynteractHCR Germany. |
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| Time | Topic | Speaker | ||
| 8:30 - 10:00 | Registration & Welcome Coffee | |||
| 10:00 - 10:15 | Conference Opening, Welcome Message for the EUCROF president. |
Dr. Martine Dehlinger-Kremer, President EUCROF. Vice-President, Global Medical and Regulatory Affairs, SynteractHCR, Germany. |
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| 10:15 - 11:00 | How did this happen? A fresh look at the Medical Industrial Complex. | Dr. h.c. Peter Kapitein, Patient advocate at Inspire2Live, The Netherlands | ||
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Clinical Trials Regulation (EU) No 536/2014 Chair: Dr. Dagmar Chase, Managing Director Clinrex GmbH, Germany. |
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| 11:05 - 11:30 | European Clinical Trials Regulation (CTR): Status Quo. | Anabela Marcal, Head of Committees and Inspections Department, European Medicines Agency (EMA), UK | ||
| 11:30 - 11:55 | Any pitfalls for industry? | Sini Eskola, Director Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium | ||
| 11:55 - 12:20 | What will change for Investigator Initiated Trials (ITTs)? | Heiko von der Leyen, Hannover Clinical Trial Center GmbH (HCTC), Germany | ||
| 12:20 - 12:45 | How will Ethic Committees be engaged under the Clinical Trials Regulation? | Prof.Dr. Joerg Hasford, Munich Institute for Medical Informatics, Biometrics, and Epidemiology, Germany; Chair of the Working Group of the German Ethics Committees | ||
| 12:45 - 13:00 | Discussion | All | ||
| 13:00 - 14:30 | Lunch Break | |||
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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, The Netherlands. Member of the Leadership Council the Society of Clinical Research sites (SCRS). |
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| 15:30 - 16:00 | Defining Risk factors and tolerance limits, hints and tips. | Pharma speaker Invited | ||
| 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 | |||
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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. |
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| 18:00 - 18:30 | eSRA - eSource Site Readiness Assessment tool: Is your EHR system suitable for originating records that will be used in regulated clinical trials? |
Dr. Yvonne Rollinger, Managing Director, Omnicomm Europe, Germany. Representative of the eClinical Forum eSRA Initiative. |
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| 20:00 | Social Event | |||
| 1st Parallel Sessions | ||||
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GCP compliance of e-Systems and Technical Solutions Chair: Alan Yeomans, Quality Manager, PCG Solutions, Sweden, Co-chair of the eClinical Forum Regulatory Expert Group, Co-chair of the EUCROF Working Group New Technologies. |
Clinical Trials in the Paediatric Population Chair: Dr. Martine Dehlinger-Kremer, President EUCROF, Vice-President, Global Medical and Regulatory Affairs, SynteractHCR, Germany, Chair of the EUCROF Working Group Paediatric. 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, Deputy Head of Children’s Memorial Health Institute, Poland. Member EMA Paediatric Committee (PDCO) |
| 9:00 - 9:30 | Contractual requirements on the responsibilities of e-Systems Vendors with regards to GCP. | Wolfgang Summa, Merck Group, Germany | Pan European Paediatric Network. |
Dr. Mark Turner, Institute of Translational Medicine, University of Liverpool, UK. Chair European Network of Paediatric Research at EMA, UK. |
| 9:30 - 10:00 | Risk based validation and Agile development. | Jesper Rosendal, Senior Manager Corporate Quality Assurance IT, Lundbeck, Denmark. | Certification of clinical trial center in paediatric perspective. |
Prof. Paolo Rossi, Director Institute of Child Health, Bambino Gesu Children’s Hospital, Italy. Member EMA Paediatric Committee (PDCO) |
| 10:00 - 10:30 | Panel Discussion. | All | The patient’s and parents’ perspective 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 | ||||
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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. |
New European Data Privacy Regulation Chair: Isabelle Abousahl, President Alcoam by design SAS, France, Member of the EUCROF Working Group New Technologies. Co-chair: Thierry Lepoutre, Managing Director, Lambda Plus, Belgium. |
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| Time | Topic | Speaker | Topic | Speaker |
| 11:00 - 11:30 | Highlights and Challenges of the EU Medical Device Regulations. | Gert Bos, Executive Director & Partner Qserve Group, 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, 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. |
Manufacturer (tbc) |
PhUSE Data de-identification standard for CDISC Data Models |
Jean-Marc Ferran, Consultant & Owner, Qualiance; Data Transparency Working Group Lead, PhUSE; Denmark |
| 12:30 - 13:30 | Lunch Break | |||
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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., Executive Vice-President Global Medical Affairs, Mapi Real World evidence, 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 Licensing pathways, Expanded Access Programs, Post Approval Efficacy Studies, Health Technology Assessment: Are we going to see the development of pragmatic/low-intervention trials in a near future? | Pharma or HTA body representative (tbc) | ||
| 14:30 - 15:00 | Impact of patient voice in peri and post-approval clinical research. How can Patient-Reported Outcomes influence HTA decisions? How can Patient Advocacy Groups can be involved in their discussions? | HTA body or Patient Advocacy Group representative (tbc) | ||
| 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), Italy Member of ENCePP Steering Group and ENCePP Working Group 2 “Independence and Transparency” |
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European Union redesigned Introduced by Dr. Martine Dehlinger-Kremer, President EUCROF |
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| 15:30 - 16:00 | Brexit: Everything that you want (& need?) to know! | Dr. Virginia Acha, Executive Director, 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, President EUCROF | ||
| 16:10 - 17:00 | Good-bye coffee | |||