CMC Strategy Forum Latin America 2023

Tuesday, 6 June 2023 – Session I: Why optimize the submission and review of CMC post-approval changes? Global trends and challenges for Latin America

Session Co-Chairs: Cammilla Horta Gomes, Produtos Roche Químicos e Farmacêuticos S.A., Karina Cuadra, Ministerio de Salud Publica de Uruguay (Invited)

Post-approval changes (PAC) to the registered information of authorized medicinal products are routinely introduced worldwide, and their review represents a significant and increasing workload for regulators. Moreover, handling many different types of dossiers for the same product and managing change implementation worldwide is burdensome for industry. In Latin America, the diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC continue to represent a challenge, with potential impact on the availability of medicinal products in the region.

The first edition of the 2023 CMC Conversations in Latin America will be a virtual interactive session, gathering regulators and industry - from the region and beyond - to explore solutions in optimizing the submission, review, and implementation process of CMC variations, focusing on convergence with international standards and adoption of best practices.

Global Trends in Lifecycle Management

Hugo Hamel, Health Canada

Manufacturing processes are often altered after regulatory approval and medicines can undergo changes during their product lifecycle. Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls of medicinal products, and often need to be implemented after the product has been approved. With the approval of new products every year, the number of post-approval changes requiring regulatory approval keep increasing and can delay

access to important drugs to patients. This presentation will highlight the importance of having a regulatory framework in place which use a risk-based approach for lifecycle management. It will also highlight different tools that are available to help manage the post-approval changes.

Online Optimized Assessment Project for CMC Variations
Carolina Blades, ANVISA

Reliance for Post-Approval Changes: An Industry Perspective
Maria Antonieta Román, Latin American Federation of the Pharmaceutical Industry - FIFARMA

Tuesday, 6 June 2023 – Session I: Why optimize the submission and review of CMC post-approval changes? Global trends and challenges for Latin America

Session Co-Chairs: Cammilla Horta Gomes, Produtos Roche Químicos e Farmacêuticos S.A., Karina Cuadra, Ministerio de Salud Publica de Uruguay (Invited)

Post-approval changes (PAC) to the registered information of authorized medicinal products are routinely introduced worldwide, and their review represents a significant and increasing workload for regulators. Moreover, handling many different types of dossiers for the same product and managing change implementation worldwide is burdensome for industry. In Latin America, the diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC continue to represent a challenge, with potential impact on the availability of medicinal products in the region.

The first edition of the 2023 CMC Conversations in Latin America will be a virtual interactive session, gathering regulators and industry - from the region and beyond - to explore solutions in optimizing the submission, review, and implementation process of CMC variations, focusing on convergence with international standards and adoption of best practices.

Global Trends in Lifecycle Management

Hugo Hamel, Health Canada

Manufacturing processes are often altered after regulatory approval and medicines can undergo changes during their product lifecycle. Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls of medicinal products, and often need to be implemented after the product has been approved. With the approval of new products every year, the number of post-approval changes requiring regulatory approval keep increasing and can delay

access to important drugs to patients. This presentation will highlight the importance of having a regulatory framework in place which use a risk-based approach for lifecycle management. It will also highlight different tools that are available to help manage the post-approval changes.

Online Optimized Assessment Project for CMC Variations
Carolina Blades, ANVISA

Reliance for Post-Approval Changes: An Industry Perspective
Maria Antonieta Román, Latin American Federation of the Pharmaceutical Industry - FIFARMA

Tuesday, 19 September 2023 - Session II: 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 Co-Chairs: Kavita Aiyer, Seagen Inc. Susan Zavala Coloma, DIGEMID-General Directorate of Medicines, Supplies and Drugs 

Post-approval changes (PAC) to the registered information of authorized medicinal products are inevitable and often present significant regulatory burden for global submission and approval. Acknowledging the regulatory complexity within Latin America presented by diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC, a strategic, scientific risk-based and nimble management of data package required for submissions and subsequent review by the health agencies is foundational to speedy access of quality medicines to patients.

There is growing support for pursuing a practical approach to better leverage resources and information among regulators to reduce regulatory complexity. Ultimately, this approach would require that regulators in all participating regions adopt standardized requirements for the formats and data expectations in regulatory submissions and apply the similar standards in regulatory review, assessment, and inspection. Importantly, this would also require that sponsors submit the aligned quality dossier for the same product in all regions (i.e., same formulation, facilities, etc.). Thus, the second session of the 2023 CMC Conversations in Latin America will focus on potential solutions for the much-needed regulatory agility and effectiveness. Considerations would be given to discussing the framework of WHO PAC guidance and the benefits. This would largely encourage adaptation of this guidance by LATAM Health agencies and thus promote standardization in management of PAC for biologics. The session will also focus on opportunities and case studies for collaborative assessments pilots, reliance pathways and industry approach towards assimilation of data packages corroborating with the risk level associated with the PACs.

Post Approval Change Management Collaboration, Creativity and Commitment in a Complex Global Environment
Sarah Miksinski, Gilead Sciences, Inc.

Accelerate CMC Post Approval Changes: The Story of a Regulatory Reliance Pilot
Heraclio Rodriguez, Sanofi

Changes Post Approval of Biological Products in Perú: Regulation and Challenges Cinthia Torres Huari, DIGEMID-General Directorate of Medicines, Supplies and Drugs

Tuesday, 19 September 2023 - Session II: 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 Co-Chairs: Kavita Aiyer, Seagen Inc. Susan Zavala Coloma, DIGEMID-General Directorate of Medicines, Supplies and Drugs 

Post-approval changes (PAC) to the registered information of authorized medicinal products are inevitable and often present significant regulatory burden for global submission and approval. Acknowledging the regulatory complexity within Latin America presented by diversity of CMC requirements and reporting change categories, regulatory gaps, and distinct procedures for PAC, a strategic, scientific risk-based and nimble management of data package required for submissions and subsequent review by the health agencies is foundational to speedy access of quality medicines to patients.

There is growing support for pursuing a practical approach to better leverage resources and information among regulators to reduce regulatory complexity. Ultimately, this approach would require that regulators in all participating regions adopt standardized requirements for the formats and data expectations in regulatory submissions and apply the similar standards in regulatory review, assessment, and inspection. Importantly, this would also require that sponsors submit the aligned quality dossier for the same product in all regions (i.e., same formulation, facilities, etc.). Thus, the second session of the 2023 CMC Conversations in Latin America will focus on potential solutions for the much-needed regulatory agility and effectiveness. Considerations would be given to discussing the framework of WHO PAC guidance and the benefits. This would largely encourage adaptation of this guidance by LATAM Health agencies and thus promote standardization in management of PAC for biologics. The session will also focus on opportunities and case studies for collaborative assessments pilots, reliance pathways and industry approach towards assimilation of data packages corroborating with the risk level associated with the PACs.

Post Approval Change Management Collaboration, Creativity and Commitment in a Complex Global Environment
Sarah Miksinski, Gilead Sciences, Inc.

Accelerate CMC Post Approval Changes: The Story of a Regulatory Reliance Pilot
Heraclio Rodriguez, Sanofi

Changes Post Approval of Biological Products in Perú: Regulation and Challenges Cinthia Torres Huari, DIGEMID-General Directorate of Medicines, Supplies and Drugs

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.

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.