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