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Conference Programme

Monday, 26 February 2018

8:30 - 10:00 Registration & Welcome Coffee
Opening of the Conference
Chair: Dr. Martine Dehlinger-Kremer, President EUCROF, Vice-President, Global Medical and Regulatory Affairs, SynteractHCR  Germany.
Time Topic Speaker
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.
Co-Chair: Dr. Ulrike Lorch, Co-Founder and Medical Director, Richmond Pharmacology, UK.
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 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)? 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
12:45 - 13:00 Discussion All
13:00 - 14:30 Lunch Break & B2B Meetings
Good Clinical Practice, the new addendum E6 (R2), Part 1: Risk Based Quality Management  
Chair: Dr. Michèle Garot, Managing Director CLINcellence, Belgium.
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).
15:30 - 16:00 Defining Risk factors and tolerance limits, hints and tips. Mag. Claudia Kriebaum, Manager, Risk Based Monitoring, Eli Lilly Regional 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
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.
20:00 Networking Dinner in the Hotel Savoyen Vienna

Tuesday, 27 February 2018

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.
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, Head of Clinical Applications and Technologies, 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. Dr. Paolo Rossi, MD, PhD, Director Institute of Child Health, Bambino Gesu Children’s Hospital, Italy.
Member EMA Paediatric Committee (PDCO)
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
  European Medical Device Regulations
Chair: Dr. Antoinette van DijkScientific 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.
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. 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
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 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), 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


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