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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.


SESSION 4: RISK-ADAPTED TRIALS/ LOW-INTERVENTIONAL TRIALS / OBSERVATIONAL TRIALS

Session Chair(s)

Surendra  Gokhale, DrSc, PhD

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)

Camelia  Mihaescu

Overview of the Guideline on Risk-Adapted Trials and Key Issues

Camelia Mihaescu

  • GCP, GLP and PhV Inspections
  • European Medicines Agency, Netherlands
Anastassia   Negrouk

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
Emma  Du Four, MBA

Real World Studies: Navigating the grey Between Interventional and Observational

Emma Du Four, MBA

  • Head of International Regulatory Policy
  • Abbvie, United Kingdom

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+41 61 225 51 51


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+41 61 225 51 49