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SESSION 4: RISK-ADAPTED TRIALS/ LOW-INTERVENTIONAL TRIALS / OBSERVATIONAL TRIALS
Session Chair(s)
Surendra Gokhale, DRSC, PHD
Senior Director, Global Regulatory Affairs and Capability Development Lead
F. Hoffmann-La Roche Ltd, Switzerland
RISK-ADAPTED TRIALS/ LOW-INTERVENTIONAL TRIALS/OBSERVATIONAL TRIALS
Speaker(s)
Overview of the Guideline on Risk-Adapted Trials and Key Issues
Camelia Mihaescu
European Medicines Agency, Netherlands
GCP, GLP and PhV Inspections
Case Study on a Low-Interventional Trial under the EU Directive – Issues Encountered and how These may be Addressed/made worse by the CTReg
Anastassia Negrouk
EORTC, Belgium
Head of International Policy Office, DPO
Real World Studies: Navigating the grey Between Interventional and Observational
Emma Du Four, MBA
Independent, United Kingdom
Independent Regulatory and R&D Policy Professional