Monday 10 February 2020
|Opening of the Conference
Chair: Martine Dehlinger-Kremer, President EUCROF,
Vice-President, SynteractHCR Germany.
|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
|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!
|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|
|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|