Session 2 - Streamline Management of Product Life Cycle Changes and Build Regulatory Efficiencies Leveraging Reliance (English)

Session Chairs: Kavita Aiyer, Global Regulatory Affairs Professional and Claudia Saidman, ANMAT - National Administration of Drugs, Food and Medical Devices 

Post-approval changes (PACs) are an essential part of product lifecycle management. Bringing CMC changes through global health authority (regulatory) systems can be a complex, lengthy process taking several years and their timely approval is critical to maintaining and ensuring continuous supply of quality medicinal products. On the face of regulatory diversity amongst National Regulatory Authorities (NRAs), WHO strongly encourages abridged regulatory pathway like “Reliance” as an effective solution fostering more equitable and timely access to quality-assured medical products. Relying on the assessment performed by a reference regulatory authority will build regulatory efficiencies for both health agencies and industry by optimizing use of effort and resources and eliminating redundancies. 

The upcoming 2024 CASSS CMC LATAM Session 2 aims to understand opportunities and challenges of implementing Reliance in the region, how can industry partner with the HAs to move this along, are there other regulatory mechanisms that might be beneficial to consider? 

Session Speaker:

ICMRA efforts to achieve Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability

Evangelos Kotzagiorgis, European Medicines Agency (EMA) and 

Stelios C. Tsinontides, CDER, FDA 

Ignite the Future - Our Exciting PAC Reliance Journey with 48 NRAs

Francesca Mangia, F. Hoffmann-La Roche Ltd

ICMRA PACMP – Biologic DS Process Change – Experience and Learnings

Lisa Little-Tranter, Merck & Co., Inc.