戻る Agenda
Session 3, Track A: Regulatory Collaboration and Cooperation Initiatives Combined with Regulatory Convergence & Harmonization
Session Chair(s)
Maria Antonieta Tony Roman, MPharm
Head Regulatory Policy Emerging Markets LATAM
Novartis, Mexico
Leonardo Semprun Semprun, PharmD
Global Regulatory Policy Lead-LatAm
MSD, Panama
Regulatory collaboration and cooperation are becoming increasingly important, given the growth in regulatory procedures related to innovative therapies, or with post-registration changes and limited resources. In this session, we will learn about agreements and experiences; we will also discuss harmonization efforts, plans and challenges in the Latin American region, explore issues related to regulatory harmonization, resource allocation, and overcoming regulatory disparities among countries. Examine the role and contribution of various sectors, including industry and academia, in the evolution of ICH standards. Discuss how collaboration between regulatory agencies and these sectors can enhance the development and implementation of effective regulatory frameworks.
Learning Objective : - Analyze the importance of collaboration and regulatory cooperation in the context of regional regulatory frameworks
- Identify the challenges and opportunities associated with collaborations and regional mechanisms
- Evaluate the implementation status of ICH guidelines in regulatory frameworks
- Analyze the challenges and obstacles faced in the adaptation and implementation of ICH guideline frameworks
Speaker(s)
PIC/S Journey in Latin America Towards Harmonization of CGMP Procedures
Representative Invited
MSD, Brazil