Session III 2023 CMC Conversations in Latin America (Insert Language)

Tuesday, 7 November 2023 – Session III: 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, Merck KGaA
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.

Post Approval Change Management - Global Harmonization Perspectives
Hanane Abdellah, Merck KGaA

The Revision of Brazilian Guidelines for Post-Approval Changes and Stability, and Its Impact on International Convergence in the Regulation of Biotechnological Products
João Tavares Neto, ANVISA

Genesis of ICH M4Q: From Inception to the Present Day
Ingrid Markovic, CBER, FDA

EMA Perspectives on International Convergence and Collaboration for CMC Submissions
Evangelos Kotzagiorgis, European Medicines Agency (EMA)

Speaker(s):

Daniela Manzoli Bravo, AbbVie SA

Silmara Cristiane da Silveira Andreoli, ANVISA

Hanane Abdellah, Merck KGaA

Evangelos Kotzagiorgis, European Medicines Agency (EMA)

Ingrid Markovic, CBER, FDA

João Tavares Neto, ANVISA

José Crisostomo, ISPCH (Chile)

Emabelle Ramnarine, Boehringer Ingelheim Fremont, Inc.

Evangelos Kotzagiorgis

European Medicines Agency (EMA)

Appearances