Agenda/Scientific Program
Session I - Tuesday, 6 June 2023 | 13:00 BRT
Why Optimize the Submission and Review of CMC Post-Approval Changes? Global Trends and Challenges for Latin America
Session II - Tuesday, 19 September 2023 | 13:00 BRT
Pathway to Optimizing Submission and Review of CMC Post-Approval Changes: Employing Scientific Risk-Based Principles, Reliance Pathways, Adoption of WHO Post-Approval Guidelines, and Collaborative Assessments
Session III - Tuesday, 7 November 2023 | 13:00 BRT
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
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NOTE: All times are Brasilia Time (BRT).
Overview
13:00 - 13:10 | CASSS & CMC Strategy Forum Latin America 2023 Welcome and Introductory Comments |
13:10 - 14:30 | One Single Dossier for Global Submissions: 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 |
14:40 - 15:40 | Panel Discussion |
15:40 - 15:45 | Closing Remarks |
15:45 | Adjourn Session III |
Speaker Presentations
Blades Carolina Brazilian Health Regulatory Agency (ANVISA) 2023
Hamel Hugo Health Canada 2023
Roman Maria Antoineta Latin American Federation of the Pharmaceutical Industry - FIFARMA 2023
Scientific Program
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