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Conrad Cairo Hotel

Nov 25, 2024 6:00 PM - Nov 27, 2024 6:00 PM

1191 Nile Corniche, Cairo, 11221, Egypt

Middle East and North Africa Conference (MENA)

This two-day conference is designed for the industry's regulatory professionals to explore the evolving pharmaceutical landscape in the MENA region and address its unique challenges, with all regional regulators present.

Parallel Session 5A: Modernising the Regulatory Framework to Enable Efficient Lifecycle Management

Session Chair(s)

Melly  Lin, MS

Melly Lin, MS

CMC Regulatory Policy Lead, Pharma Technical Regulatory

F. Hoffmann-La Roche Ltd, Switzerland

May  Shawky

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)

Melly  Lin, MS

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

Hebatullah  Ibrahim

EDA’s Experience - Reliance for Post-Approval Changes

Hebatullah Ibrahim

Egyptian Drug Authority (EDA), Egypt

General Manager of biological Products General Administration

Susanne  Ausborn, PhD

Case Study: Outcome of PAC Reliance Pilot with 48 countries

Susanne Ausborn, PhD

Roche, Switzerland

Global Head International Regulatory Policy

Ibrahim  Tlili, PharmD, MPH, MSc

Case Study: Reliance and PACMPs to Accelerate a Major PAC Approval

Ibrahim Tlili, PharmD, MPH, MSc

MSD, Switzerland

Senior Scientist, International CMC EU/EEMEA

Sumaya  Husain

Panel Discussion with Q and A, with the additional participation of:

Sumaya Husain

National Health Regulatory Authority (NHRA), Bahrain

Clinical Trials Regulations Specialist

Donia  Albastaki

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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