Agenda/Scientific Program

One Single Dossier for Global Submissions:
The Role of Regulatory Convergence and Harmonization to Improve Efficiency and Reduce the Regulatory Burden of CMC Post-Approval Changes
Session Co-Chairs:
Daniela Manzoli Bravo, AbbVie SA
Ana Padua, EMD Serono
Silmara Cristiane da Silveira Andreoli, ANVISA

Imagine a world where a single dossier can be used worldwide, reducing the regulatory burden for industry and regulators, and accelerating access to better quality therapeutical products to the patients. Although it seems a very long-term new world to prospect, lots of ongoing global initiatives are contributing to this result. The international convergence and harmonization on the regulatory requirements are the first steps that need to be achieved to reduce the global regulatory complexity and support this outcome, but they are still challenges to overcome.

The first and second editions of the CMC Strategy Forum Latin America explored how the CMC post-approval changes represents a significant and increasing workload for regulators and industry and approached some potential solutions for the much-needed regulatory agility and effectiveness, as the convergence with international standards and the implementation of best practices such as reliance and collaborative assessments. 

The third edition of the CMC Strategy Forum Latin America will continue to explore the challenges for achieving the desirable convergence and harmonization for the CMC post-approval changes and the consequences of the diversity of requirements, as well as some ongoing initiatives that support the “one single dossier” to become a reality in the future.

 

14:30 - 14:40 
 

Break 
 

Panel Discussion