Monday 10 February 2020
| Opening of the Conference Chair: Dr. 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 | 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 | |