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

Programme

Monday 10 February 2020

Opening of the Conference
Chair: Martine Dehlinger-Kremer, President EUCROF & Vice-President Pediatric Development, Synteract, Germany.
Time Topic Speaker
08:30 - 10:00 Registration & Welcome Coffee
09:30 – 09:45 Conference Opening Martine Dehlinger-Kremer, President EUCROF
09:45 – 10:30 Strategic imperatives for Clinical Research in Europe Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicine Agency (EMA) , Amsterdam, The Netherlands
10:30 – 11:00 FDA Support for Clinical Trial Innovation 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 - 12:00 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
12:00 - 12:30 Direct to Patient Trials for an Improved Patient Experience and an Increased Efficiency for Stakeholders Bert Hartog, Sr Director Clinical innovation, Janssen Research & development, Beerse, Belgium 
12:30 - 13:00 Direct to Patient Logistics: a Patient Centric Model for Clinical Trials Raffaele Laciti, Product Manager Clinical Trial Supply, NCEE World Courier, Germany; Gold Sponsor
13:00 - 14:30 Lunch
GCP (R6) addendum: Achieving a Meaningful Oversight of CRO & Subcontractors, a Sponsor Obligation
Chair: Michèle Garot, Managing Director, Clincellence, Belgium
14:30 - 15:00 Sponsor Oversight:
Key Elements and Challenges from the Perspective of Regulators
Gabriele Schwarz, Head GCP inspectorate, Federal Institute for Drugs and Medical Devices, BfArm, Bonn, Germany
15:00 - 15:30 IT Compliance as a Critical Component in Conducting Oversight: the Sponsor Experience Caroline Sandström, Compliance Director, Global Quality Assurance (R&D), Ferring Pharmaceuticals, Copenhagen, Denmark
15:30 - 15:45 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, Paris, France
15:45 - 16:15 GDPR in Clinical Trials (overview): Progress with Understanding and Complying with the Regulation Agency representative invited
16:15 - 16:45 Coffee Break
New guidance on "Optimisation of Safety Data Collection" (E19): Is Light Shining at the End of the Tunnel?
Chair: Xavier Fournie, Corporate Medical Director, VP Global Medical Affairs, ICON Commercialisation & Outcomes, Paris, France
16:45 - 17:15 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, Bonn, Germany
17:15 - 18:00 Implementation, Gaps and Challenges: Stakeholders discussion engaging the audience Gabriele Schwarz
Guy DEMOL, Assoc. Vice-president, EU QPPV at MSD & EFPIA deputy topic leader for the ICH E19 EWG, Brussels, Belgium
 
Patrice Verpillat, Director Global Epidemiology, Merck Healthcare KGaA, Germany and Efpia observer at ENCePP Steering Committee & Topic lead in ICH Pharmacoepidemiology Discussion Group
18:00 End of DAY 1  
18:30 - 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: Kate Smirnova, Member of the EUCROF “GDPR Code of Conduct“ Working Group
Time Topic Speaker
08:00 - 09:00 Stakeholder interactive (in-depth) Discussions on a Pragmatic Implementation of the Regulation (Code of Conduct) GDPR Working Party representative confirmed
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, Uppsala, Sweden
09:00 - 09:30 Regulatory Expectations for the Long-term Archiving of Data Lisbeth Breghnøj, Medicines Inspector, Danish Medicine Agency, Copenhagen, Denmark
09:30 - 10:00 Using Wearables and Smart Devices in Clinical Trials Wolfgang Summa, Head of Clinical Applications and Technologies, Biopharma, Global Clinical Operations, Merck Group, Darmstadt, Germany
10:00 - 10:30 eConsent - Tips and Tricks from the Trenches David Fauvart, Associate Director, Janssen Clinical Innovation, Janssen Pharmaceutica, Beerse 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 , Italy
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 & Chief Science Officer daVinci Digital Therapeutics, Verona, Italy
13:00 - 13:30 Situation of Advance 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, Madrid, Spain
13:30 - 14:30 Lunch Break
Data! Are you making the most of it?
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, Munich, Germany
15:00 - 15:30 eSRA: Can Your Site Electronic Health Record Systems (EHR) be Used to Source Clinical Research Data? Yvonne Rollinger, eClinical Forum representative, Germany
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, Zurich, Switzerland
16:00 - 16:30 Using National Data Sets to target Clinical Research, and Innovative Approach in England Stephen Lock, Head of Business Intelligence, CRN National Coordinating Centre (CRNCC), NIHR (National Institute for Health Research) Clinical Research Network, Leeds, UK
16:30 - 16:40 Conference Closure, Good Bye message from the EUCROF president Martine Dehlinger-Kremer, President EUCROF & Vice-President Pediatric Development, Synteract, Germany
16:40 - 17:00 Coffee

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