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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)
EU New Variations Guideline
Marie Kirman
EFPIA MQEG & CMC Regulatory Affairs Director, Astrazeneca, United Kingdom
Benchmarking of PAC within Middle East Region
Tala Habib
Chair-Jordan Regulatory WG & Associate Director, Regulatory Affairs (Levant), MSD , Jordan
Turkish Health Authority’s Experience in Implementing Reliance in LCM
Kubra Ekinci
Pharmacist at the Coordination Department, Turkish Medicines and Medical Devices Agency (TITCK), Turkey
Simplifying Lifecycle Management -Summary of PAC Reliance Pilots supported by EMA
Susanne Ausborn, PhD
Global Head International Regulatory Policy, Roche, Switzerland
Panel Discussion with Q&A (With the additional participation of):
Hussah Albehaijan
Head of Innovative Pharmaceuticals and Investigational Drugs Section, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Panel Discussion with Q&A (With the additional participation of):
Mariam Maged
Manager - Human pharmaceuticals Variations Administration , Egyptian Drug Authority (EDA), Egypt
Panel Discussion with Q&A (With the additional participation of):
Panellist(s) Invited
, Qatar
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