Opening of the Conference
Chair: Dr. Martine Dehlinger-Kremer, President EUCROF, Vice-President, Global Medical and Regulatory Affairs, SynteractHCR Germany.
|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.
|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|
Clinical Trials Regulation (EU) No 536/2014
Chair: Dr. Dagmar Chase, Managing Director Clinrex GmbH, Germany.
|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|
Good Clinical Practice, the new addendum E6 (R2), Part 1: Risk Based Quality Management
Chair: Dr. Michèle Garot, Managing Director CLINcellence, Belgium.
|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).
|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|
Part 2: Operating Models further re-enforced by new regulations & guidelines
Chair: Yoanni Th. Matsakis, President Telemedicine Technologies S.A.S., France.
|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||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.
|1st Parallel Sessions|
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.
|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|
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.
|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.||
|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|
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.
|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”
European Union redesigned
Introduced by Dr. Martine Dehlinger-Kremer, President EUCROF
|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|