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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, SynteractHCR 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 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.
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
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
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
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

eTOOLS: When Opportunities and Challenges Coexist, Pragmatic Solutions Become Essential!
CHAIR: Alan Yeomans, EUCROF, Chairman of the “New Technologies“ Working Group & Quality Manager, VieDoc, Sweden

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

Today’s Future
CHAIR: Antoinette van Dijk,  Managing Director , D.O.Research , Italy

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

 

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