Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

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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

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