5th European Conference
on Clinical Research
February 10-11, 2020, Amsterdam, The Netherlands


Monday 10 February 2020

Opening of the Conference
Chair: Martine Dehlinger-Kremer, President EUCROF
Time Topic Speaker
08:30 - 09:30 Registration & Welcome Coffee
09:30 – 09:45 Conference Opening Martine Dehlinger-Kremer, President EUCROF, Germany
09:45 – 10:30 Strategic imperatives for Clinical Research in Europe Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency (EMA) , The Netherlands
10:30 – 11:00 Collaborating With The FDA To Facilitate Innovation: An RBM Example Douglas Peddicord, Executive Director, ACRO, USA
11:00 -11:30 Coffee Break  
Patient Centric Approach, the Effective Partnership!
Chair: Michèle Garot, Managing Director, CLINcellence, Belgium
11:30 - 11:50 Steadily Evolving Role of Patient Organisations in Drug Development: The Duchenne Example Elizabeth Vroom, Founder & President of the Duchenne Parent Project, Chair of the World Duchenne Organization (UPPMD), The Netherlands
11:50 - 12:10 Direct to Patient Trials for an Improved Patient Experience and an Increased Efficiency for Stakeholders Bert Hartog, Sr Director Clinical innovation, Janssen Research & development, Belgium 
12:10 - 12:30 Direct to Patient Logistics: a Patient Centric Model for Clinical Trials Raffaele Laciti, Product Manager Clinical Trial Supply, NCEE World Courier, Germany; Gold Sponsor
12:30 - 13:00 Panel discussion engaging the audience


13:00 - 14:00 Lunch
GCP (R6) addendum: Achieving a Meaningful Oversight of CRO & Subcontractors, a Sponsor Obligation
Chair: Michèle Garot, Managing Director, Clincellence, Belgium
14:00 - 14:25 Sponsor Oversight:
Key Elements and Challenges from the Perspective of Regulators
Gabriele Schwarz, Head GCP inspectorate, Federal Institute for Drugs and Medical Devices, BfArm, Germany
14:25 - 14:50 IT Compliance as a Critical Component in Conducting Oversight: the Sponsor Experience Caroline Sandström, Compliance Director, Global Quality Assurance (R&D), Ferring Pharmaceuticals, Denmark
14:50 - 15:15 Panel Discussions Speakers 
GDPR in Clinical Trials, Challenges in Implementation
Chair: Yoani Matsakis, Leader of the EUCROF "GDPR Code of Conduct" working group & President, Telemedicine Technologies, France
15:15 - 15:45 GDPR in Clinical Trials (overview): Progress with Understanding and Complying with the Regulation Hélène Guimiot-Breaud, Head of healthcare services sector, CNIL, France
15:45 - 16:15 Coffee Break
New guidance on "Optimisation of Safety Data Collection" (E19): Is Light Shining at the End of the Tunnel?
Chair: Xavier Fournie, Executive Medical Director, Scientific Medical Affairs, ICON Commercialisation & Outcomes, France
16:15 - 16:45 Selective Safety Data Collection Approach: Salient Points and Current Status of the New E19 Guidance Gabriele Schwarz, Member of the ICH E19 Expert Group, Head GCP inspectorate, Federal Institute for Drugs and Medical Devices, BfArm, Germany
16:45 - 17:30 Implementation, Gaps and Challenges: Stakeholders discussion engaging the audience Gabriele Schwarz, see above
Guy DEMOL, Assoc. Vice-president, EU QPPV at MSD & EFPIA deputy topic leader for the ICH E19 EWG, Belgium
Patrice Verpillat, Director Global Epidemiology, Merck Healthcare KGaA, Germany and Efpia observer at ENCePP Steering Committee & Topic lead in ICH Pharmacoepidemiology Discussion Group
Wishing that Hype Becomes Reality...
Chair: Michèle Garot, Managing Director, Clincellence, Belgium
17:30 - 18:00 When Hype Becomes Reality: How AI, Machine Readable Data and Patient Centric Technology Will Shape the Future of Clinical Trials Derk Arts, Founder and CEO, CastorEDC, the Netherlands; Gold Sponsor
18:00 End of DAY 1  
19:00 - 22:00 Social Event at the Heineken Experience and celebration of 3 Professional Organisation anniversaries

Tuesday 11 February 2020


Interactive Working Session: GDPR in details
CHAIR: Ekaterina Smirnova , CIPP, Data Protection Officer, PSI , Zug, Switzerland & Member of the EUCROF “GDPR Code of Conduct“ Working Group
Time Topic Speaker
08:00 - 09:00 The GDPR in Clinical Research: Code of Conduct as a Vehicle to Bring Opinions Together Yoani Th. Matsakis, President of Telemedicine Technologies, France & co-Chair of the EUCROF “New Technologies“ Working Group
08:00 - 09:00 Panel discussion engaging the audience Hélène Guimiot-Breaud, Head of healthcare services sector, CNIL, France
Claire Gayrel, Legal Officer, Policy & Consultation Unit, EDPS, Belgium
eTOOLS: When Opportunities and Challenges Coexist, Pragmatic Solutions Become Essential!
CHAIR: Alan Yeomans, EUCROF, Chairman of the EUCROF “New Technologies“ Working Group & Quality Manager, Viedoc, Sweden
09:00 - 09:30 Regulatory Expectations for the Long-term Archiving of Data Lisbeth Breghnøj, Medicines Inspector, Danish Medicine Agency, Denmark
09:30 - 10:00 Using Wearables and Smart Devices in Clinical Trials Wolfgang Summa, Head of CMO Informatics, Biopharma, R&D Informatics, Merck Group, Germany
10:00 - 10:30 eConsent - Tips and Tricks from the Trenches David Fauvart, Associate Director, Janssen Clinical Innovation, Janssen Pharmaceutica, Belgium
10:30 - 11:00 Panel Discussion Speakers and Guests
11:00 - 11:30 Coffee Break
Today’s Future
CHAIR: Antoinette van Dijk,  Managing Director , D.O.Research , Switzerland
11:30 - 12:00 Innovative Study designs: Pros, Cons and challenges! Joerg Hasford, Institute for Medical Informatics, Biometry and Epidemilogy (IBE), Munich & Chair of the working group of the German Ethics Committees, Germany
12:00 - 12:30 Research Infrastructures for Paediatric Research in Europe Mark Turner, Co-coordinator of conect4children (c4c) & Professor of Neonatology and Research Delivery at University of Liverpool, UK
12:30 - 13:00 Research and Development of Digital Therapeutics #DTx, a New Generation of Evidence-Based Prescription Interventions Giuseppe Recchia, VP Smith Kline Foundation and Co-Founder & CEO daVinci Digital Therapeutics, Italy
13:00 - 13:30 Situation of Advanced Therapies in Europe and Main Challenges for the Future Sol Ruiz, CHMP representative at the CAT (Committee for Advanced Therapies) of the European Medicines Agency & Head of Biologics, Biotechnology and Advanced Therapies, Spanish Medicines Agency, Spain
13:30 - 14:30 Lunch Break
Data! Are you making the most of it?
CHAIR: Alan Yeomans, EUCROF, Chairman of the EUCROF “New Technologies“ Working Group & Quality Manager, Viedoc, Sweden
14:30- 15:00 Artificial Intelligence: What is it, and How is it Transforming Healthcare? Sharad Gandhi, Principal Consultant - AI and Business Strategy, Market. Consult, Germany
15:00 - 15:30 eSRA: Can Your Site Electronic Health Record Systems (EHR) be Used to Source Clinical Research Data? Martijn Griep, eClinical Forum Representative & Associate Director, Janssen, The Netherlands
15:30- 16:00 Real World Data for Approval and HTA, How Important is it in the Real World? Peter Rutherford, Global Medical Lead Rare Disease, Vifor Pharma, Switzerland
16:00 - 16:30 Using National Data Sets to target Clinical Research, An Innovative Approach in England Stephen Lock, Head of Business Intelligence, CRN National Coordinating Centre (CRNCC), NIHR (National Institute for Health Research) Clinical Research Network, UK
16:30 - 16:40 Conference Closure, Good Bye message from the EUCROF president Martine Dehlinger-Kremer, President EUCROF, Germany
16:40 - 17:00 Coffee Break

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