Monday 10 February 2020
| Opening of the Conference Chair: Martine Dehlinger-Kremer, President EUCROF & Vice-President Pediatric Development, Synteract, Germany. |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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|---|---|---|
| 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 |
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| 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 |
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| 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 | |