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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
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)
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