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Parallel Session 5A: Modernising the Regulatory Framework to Enable Efficient Lifecycle Management
Session Chair(s)
Melly Lin, MS
CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
May Shawky
Regional Manager Regulatory Affairs MEAR
Merck Group, United Arab Emirates
This session will focus on recent updates regarding the modernisation of the regulatory framework to facilitate the timely approval of PACs (Post-Approval Changes), including EDA’ s experience in reliance implementation to the variations’ system. In addition, two case studies from industry will be shared regarding how to enhance the use of reliance and PACMP (Post Approval Change Management Protocol) to accelerate PAC approval. Regulators and industry will discuss how to optimise the LCM framework by leveraging the lessons learnt from case studies, opportunities for harmonisation with international guideline and including PACMP in the local guideline, with the ultimate goal of enabling fast approval of PACs and securing supply of medicines to patients.
Speaker(s)
Introduction and Setting the Scene: EFPIA MERN Survey on PAC management system in Middle East and North Africa
Melly Lin, MS
F. Hoffmann-La Roche Ltd, Switzerland
CMC Regulatory Policy Lead, Pharma Technical Regulatory
EDA’s Experience - Reliance for Post-Approval Changes
Hebatullah Ibrahim
Egyptian Drug Authority (EDA), Egypt
General Manager of biological Products General Administration
Case Study: Outcome of PAC Reliance Pilot with 48 countries
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Case Study: Reliance and PACMPs to Accelerate a Major PAC Approval
Ibrahim Tlili, PharmD, MPH, MSc
MSD, Switzerland
Senior Scientist, International CMC EU/EEMEA
Panel Discussion with Q and A, with the additional participation of:
Sumaya Husain
National Health Regulatory Authority (NHRA), Bahrain
Clinical Trials Regulations Specialist
Panel Discussion with Q and A, with the additional participation of:
Donia Albastaki
Drug and Food Control, Ministry of Health, Kuwait
Head of Drug Registration Department
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