Back to Agenda
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
GCP, GLP and PhV Inspections
European Medicines Agency, Netherlands
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
Head of International Policy Office, DPO
EORTC, Belgium
Real World Studies: Navigating the grey Between Interventional and Observational: Emma Du Four, MBA
Regulatory and R&D Policy Professional
-, United Kingdom
Have an account?