Session 1 - Convergence of Regulatory Variation Category Assignment and Defined Health Authority Review Timelines through Risk-based Assessment of Post Approval Changes (Spanish)

Session Chairs: Cammilia Horta Gomes, Produtos Roche Quimicos e Farmaceuticos S.A. and Susan Zavala Coloma, DIGEMID - General Directorate of Medicines, Supplies and Drugs

Simplification of the regulatory processes and adhering to common fundamentals for managing post-approval changes would enable international collaboration and cooperation towards regulatory convergence and consequentially speed to market of quality medicines. This can be achieved by harmonized change classifications, leveraging scientific risk-based principles for regulatory evaluations and decision making, adherence to defined and predictable review timelines, collaboration and open dialogues between Industry and Regulators as well as the use of novel regulatory, and scientific tools and practices.

The upcoming 2024 CASSS CMC LATAM Session 1 will continue conversations for understanding barriers enabling Risk-based classification of PACs, promoting convergence of regulatory variation reporting category assignment and defined HA review timelines and partner with HAs in the regions to identify pragmatic solutions like Reliance enabling regulatory efficiencies.

Session Speakers:

Approaches to Design an Efficient, Predictable Global Post‑approval Change Management System that Facilitates Continual Improvement and Product Availability

Emabelle Ramnarine, Boehringer Ingelheim International GmbH.

Regulatory Advances in Post Approval Changes of Biological Products in Peru

Cinthia Noemi Torres Huari, General Directorate of Medicines, Supplies and Drugs, Peru (DIGEMID)

Regulatory Convergence in Latin America: Overcoming Challenges in Post-Registration

Patricia Almeida, Eurofarma Laboratórios