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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 Mohamed
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)
Melly Lin, MS
CMC Regulatory Policy Lead, Pharma Technical Regulatory, F. Hoffmann-La Roche Ltd, Switzerland
Introduction and Setting the Scene: EFPIA MERN Survey on PAC management system in Middle East and North Africa
Hebatullah Ibrahim
General Manager of biological Products General Administration, Egyptian Drug Authority (EDA), Egypt
EDA’s Experience - Reliance for Post-Approval Changes
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
Case Study: Outcome of PAC Reliance Pilot with 48 countries
Ibrahim Tlili, PHARMD, MPH, MSC
Senior Scientist, International CMC EU/EEMEA, MSD, Switzerland
Case Study: Reliance and PACMPs to Accelerate a Major PAC Approval
Sumaya Husain
Clinical Trials Regulations Specialist, National Health Regulatory Authority (NHRA), Bahrain
Panel Discussion with Q and A, with the additional participation of:
Donia Albastaki
Acting Director, Pharmaceutical and Herbal Medicine Registration & Control Admin, Ministry of Health, State of Kuwait, Kuwait
Panel Discussion with Q and A, with the additional participation of: