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Session 8: Suppy Chain & Sample Management
Session Chair(s)
Joerg Garbe, PhD, MSc
Global Quality Manager & Policy Lead
F. Hoffmann-La Roche Ltd, Switzerland
Doaa Rady
Lot Release administration manager
Egyptian Drug Authority (EDA), Egypt
This Session will explore the global trend of using a Reliance-based waiver for in-country testing. Regulators will share their practical experiences with risk-based surveillance testing to replace import/registration testing. The goal of this session is to support regulators in the MENA region in optimising their testing systems to avoid waste of resources and ensure no delay of drug supply to patients.
Speaker(s)
Introduction: Global Trends and Regional Perspective
Joerg Garbe, PhD, MSc
F. Hoffmann-La Roche Ltd, Switzerland
Global Quality Manager & Policy Lead
Regional Perspective on In-Country Testing
Rania Elafifi
Roche, Egypt
Regulatory Affairs Lead - Egypt
Practical Implementation of Risk-Based Strategies and Optimized Testing Systems in Egypt
Doaa Rady
Egyptian Drug Authority (EDA), Egypt
Lot Release administration manager
Risk-based Surveillance Testing in Serbia and How it Complements Anti-Counterfeit Activities in Serbia
Pavle Zelic
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
International Cooperation, European Integrations and Public Relations
Panel Discussion with QandA, with the additional participation of:
Rana Malkawi
Jordan Food and Drug Administration (JFDA), Jordan
Drug Directorate Director
Panel Discussion with QandA, with the additional participation of:
Agnes Chan
Health Sciences Authority Singapore, Singapore
Regulatory Consultant with the Pharmaceuticals & Biologics Branch