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

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  

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