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


Monday 10 February 2020

Opening of the Conference
Chair: Dr. 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 Dr. 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 Coffee Break  
Patient Centric Approach, the effective partnership!
11:00 - 11.30 Decentralized Clinical Trials (title is being defined) Bert Hartog, PhD, Sr Diretor Clinical innovation, Janssen Research & development, Belgium
11:30 - 12.00 Patient Engagement (title is being defined) Elizabeth Vroom, Founder & President of the Duchenne Parent Project, Netherlands
12:00 - 12.30 Direct-to-Patient (DtP- i.e. Drug delivered at patient’s home), success factors and pitfalls Speaker tbd
12:30 - 13.00 GOLD SPONSOR presentation  
13:00 - 14:30 Lunch
GCP: Quality Management System and Oversight, Is there a missing link?
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
15:45 - 16:15 GDPR in Clinical Trials: CROs taking leadership to facilitate compliance 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?
16:45 - 17:45 Rationale and solutions proposed by  this guideline.
How to implement?
Gaps and challenges identified by Industry/CROs
What would be the inspection perspective?
EFPIA Pharma representative
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, invited
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
Time Topic Speaker
08:00 - 09:00 GDPR: When CROs take leadership to facilitate compliance with the regulation (Code of Conduct); In-depth discussions Eucrof Working Party representative
eTOOLS: When Opportunities and Challenges coexist, Pragmatic Solutions Become Essential!
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 Agency representative invited
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
11:30 - 12:00 Innovative Study designs: pro’s, con’s and challenges! Agency representative invited
12:00 - 12:30 European Research Infrastructure for Paediatrics Speaker invited
12:30 - 13:00 Digital Therapeutics, transforming clinical Trial outcome! (evidence-based therapeutic interventions) (title to be defined) Pharma speaker invited
13:00 - 13:30 Advanced therapy medicinal products (ATMPs) (Title to be defined) 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? Dr. 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? Pharma speaker Invited
16:30 - 16:40 Conference Closure, Good Bye message from the EUCROF president Dr. Martine Dehlinger-Kremer, President EUCROF
16:40 - 17:00 Coffee


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