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SESSION 3: Optimising LCM in ME: Leveraging Regulatory Tools to Secure Medicine Supply for Patients in the MEA Region
Session Chair(s)
Melly Lin, MS
CMC Regulatory Policy Lead, Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Switzerland
Patricia Salami
Senior Director, Regional RA Head - MEAR (Middle East_Africa_Turkey_Russia_CIS), Merck, United Arab Emirates
Overview: In this Session, we will explore opportunities to optimise Lifecycle Management (LCM) in the Middle East & Africa regions by expanding the use of modern regulatory tools (e.g. risk-based approach, ICH Q12, Reliance), with the overall objective of securing supply to patients.
Speaker(s)
Marie Kirman
EFPIA MQEG & CMC Regulatory Affairs Director, Astrazeneca, United Kingdom
Tala Habib
Chair-Jordan Regulatory WG & Associate Director, Regulatory Affairs (Levant), MSD , Jordan
Kubra Ekinci
Pharmacist at the Coordination Department, Turkish Medicines and Medical Devices Agency (TITCK), Turkey
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
Hussah Albehaijan
Head of Innovative Pharmaceuticals and Investigational Drugs Section, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Mariam Maged
Manager - Human pharmaceuticals Variations Administration , Egyptian Drug Authority (EDA), Egypt
Panellist(s) Invited
, Qatar
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