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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

Bringing changes through global Health Authority systems can be a complex lengthy process and can take up to several years, impacting timely access to medicine and important patient information. This session will focus on recent update regarding modernization of regulatory framework to facilitate the timely approval of PAC (post approval change), including EU variation guideline update, EDA’ s experience in reliance implementation to variation 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 optimize LCM framework by leveraging the lessons learnt from case studies, opportunity to harmonization with international guideline and include PACMP to local guideline, with the ultimate goal of enabling fast approval of PACs and securing supply of medicines to patients.

Speaker(s)

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

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