Monday 10 February 2020
| Opening of the Conference Chair: Martine Dehlinger-Kremer, President EUCROF, Vice-President, SynteractHCR 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 | Key note speaker (title is being defined) | Fergus Sweeney, Head of Compliance & Inspection Patient Health Protection, European Medicine Agency (EMA) , Netherlands |
| 10:30 – 11:00 | US / FDA strategic perspective in Clinical Research (title is being further defined) | ACRO representative, Association of Clinical Research Organisation |
| 11:00 -11:30 | Coffee Break | |
| Patient Centric Approach, the Effective Partnership! | ||
| 11:30 - 12:00 | Decentralized Clinical Trials (title is being defined) | Bert Hartog, PhD, Sr Diretor Clinical innovation, Janssen Research & development, Belgium |
| 12:00 - 12:30 | The 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), Netherlands |
| 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: Quality Management System and Oversight, Is there a Missing Link? Chair: Michèle Garot, Managing Director, Clincellence Belgium. |
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| 14:30 - 15:00 | Sponsor Oversight: Understand GCP requirements to meet Regulator Expectations |
Gabriele Schwarz, Head GCP inspectorate, Federal Institute for Drugs and Medical Devices, BfArm, Germany, invited |
| 15:00 - 15:30 | Clinical QMS to enhance Quality and Efficiency throughout Clinical Development: pitfalls and weaknesses | Muriel Cottard, Global Drug development QA, Novartis, Switzerland |
| 15:30 - 15:45 | Panel Discussions | Speakers and Guests |
| GDPR in Clinical Trials, challenges in implementation Chair: Yoani Matsakis, EUCROF, Team Leader of the GDPR Code of Conduct team |
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| 15:45 - 16:15 | GDPR in Clinical Trials: progress with understanding and complying with the Regulation (overview) | 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, France |
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| 16:45 - 17:45 | New solutions (and rationale) proposed for the collection of Safety Data. How to implement? Gaps and challenges identified by Industry/CROs? What would be the Inspector perspective? |
EFPIA Pharma representative confirmed Gabriele Schwarz, Head GCP inspectorate, Federal Institute for Drugs and Medical Devices, BfArm, Germany, invited |
| 17:45 - 18:00 | Panel discussion | EFPIA Pharma representative Gabriele Schwarz, Head GCP inspectorate, Federal Institute for Drugs and Medical Devices, BfArm, Germany |
| 18:00 | End of DAY 1 | |
| 18:30 - 22:00 | Social Event at the Heineken Experience and celebration of 3 anniversaries | |
Tuesday 11 February 2020
| Interactive Working Session: GDPR in details> CHAIR: Yoani Matsakis, EUCROF, Team Leader of the “GDPR Code of Conduct“ Working Group & President , Telemedicine Technologies, France |
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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) | Eucrof Working Party representative |
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eTOOLS: When Opportunities and Challenges Coexist, Pragmatic Solutions Become Essential! |
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| 09:00 - 09:30 | Regulatory expectations for the long-term archiving of data | Agency representative invited |
| 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, Germany |
| 10:00 - 10:30 | Regulatory aspects on the use of electronic Informed Consent | Agency representative invited |
| 10:30 - 11:00 | Panel Discussion | Speakers and Guests |
| 11:00 - 11:30 | Coffee Break | |
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Today’s Future |
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| 11:30 - 12:00 | Innovative Study designs: pro’s, con’s and challenges! | Speaker to be announced |
| 12:00 - 12:30 | European Research Infrastructure for Paediatrics | Mark Turner, Chair European Network of Paediatric Research, EMA & Lecturer in Neonatology, 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, Vice President Smith Kline Foundation and Co-Founder & Chief Science Officer daVinci Digital Therapeutics |
| 13:00 - 13:30 | Situation of Advance Therapies in Europe and main challenges for the future | Agency representative invited |
| 13:30 - 14:30 | Lunch Break | |
| Data – Are you making the most of it? | ||
| 14:30- 15:00 | Artificial Intelligence in R&D | Sharad Gandhi |
| 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 |
| 15:30- 16:00 | Use of Patient Registries for regulatory purposes: Securing regulators’ confidence in the results | Speaker to be announced |
| 16:00 - 16:30 | Can we research ‚smarter‘ using RWE? (title is being further defined) | Pharma speaker Invited |
| 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 | |