Programme

DAY 1

08:00 - 09:30	Registration
09:30 - 11:00	Conference Opening Key note speaker	Sharing a Strategic Vision
11:00 - 11:30	Break
11:30 -13.30	Decentralized Clinical Trials Patient Engagement Patient acting as an Essential Contributor	Study Design, Patient Active Contribution and Engagement: when patients centricity creates a positive spiral ...
13:30 - 14:30	Lunch
	Quality Management System Sponsor Oversight, Regulator Expectations (e)TMF GDPR update and code of conduct	GCP Revision 2: challenges and solutions, DO's and DON'Ts to better fulfil your GCP obligations .
16:30 - 17:00	Coffee break
17:00- 18:30	E consent e Source Decommissioning & archiving Tailored Monitoring in Late Phase studies	Interactive workshops, a unique opportunity to understand & discuss EMA recent guidelines. (Parallel sessions, pre-registration required)
19:30	Social event

DAY 2

8:30 - 10:00	Paediatrics GDPR in details Rare Diseases	Parallel sessions, Recent trends and Regulatory updates
10:00 - 10:30	Coffee break
10:30 - 11:30	Advanced Therapies Artificial Intelligence in R&D	Did you know? Innovation in today's future
11:30 - 12:30	Safety reporting requirements for PRO assessments Use of Patient Registries for regulatory purposes	Understand FDA Vs EMA perspectives. Securing regulators’ confidence in the results
12:30 - 14:00	Lunch
14:00 - 16:00	E consent e Source Decommissioning & archiving Monitoring in in Late Phase studies	Workshop debriefing "The salient points" at a glance
16:00	Conference Closure