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CMC Strategy Forum Latin America 2023

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  • Members

  • Thumbnail for Session I 2023 CMC Conversations in Latin America (English)

    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

    Speakers

    Speaker Image for Cammilla Horta Gomes
    Produtos Roche Químicos e Farmacêuticos S.A.
    Speaker Image for Karina Cuadra
    Ministerio de Salud Publica de Uruguay
    Speaker Image for Maria Roman
    Latin American Federation of the Pharmaceutical Industry - FIFARMA

    This product is only available to members of the following groups:

    • Members
  • Thumbnail for Session I 2023 CMC Conversations in Latin America (Spanish)

    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

    Speakers

    Speaker Image for Cammilla Horta Gomes
    Produtos Roche Químicos e Farmacêuticos S.A.
    Speaker Image for Karina Cuadra
    Ministerio de Salud Publica de Uruguay
    Speaker Image for Maria Roman
    Latin American Federation of the Pharmaceutical Industry - FIFARMA

    This product is only available to members of the following groups:

    • Members
  • Thumbnail for Session II 2023 CMC Conversations in Latin America (English)
    Date
    September 19, 2023

    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

    Speakers

    Speaker Image for Kavita Aiyer
    Seagen Inc.
    Speaker Image for Susan Zavala Coloma
    DIGEMID-General Directorate of Medicines, Supplies and Drugs
    Speaker Image for Sarah Pope Miksinski
    Gilead Sciences, Inc.
    Speaker Image for Cinthia Huari
    DIGEMID-General Directorate of Medicines, Supplies and Drugs

    This product is only available to members of the following groups:

    • Members
  • Thumbnail for Session II 2023 CMC Conversations in Latin America (Spanish)
    Date
    September 19, 2023

    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

    Speakers

    Speaker Image for Kavita Aiyer
    Seagen Inc.
    Speaker Image for Susan Zavala Coloma
    DIGEMID-General Directorate of Medicines, Supplies and Drugs
    Speaker Image for Sarah Pope Miksinski
    Gilead Sciences, Inc.
    Speaker Image for Cinthia Huari
    DIGEMID-General Directorate of Medicines, Supplies and Drugs

    This product is only available to members of the following groups:

    • Members
  • Thumbnail for Session III 2023 CMC Conversations in Latin America (English)
    Date
    November 7, 2023

    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.

    Speakers

    Speaker Image for Daniela Manzoli Bravo
    Bayer S.A. – Brazil
    Speaker Image for Hanane Abdellah
    Merck KGaA
    Speaker Image for Evangelos Kotzagiorgis
    European Medicines Agency (EMA)
    Speaker Image for Ingrid Markovic
    Genentech, a Member of the Roche Group
    Speaker Image for José Crisostomo
    ISPCH (Chile)
    Speaker Image for Emabelle Ramnarine
    Boehringer Ingelheim Fremont, Inc.

    This product is only available to members of the following groups:

    • Members
  • Thumbnail for Session III 2023 CMC Conversations in Latin America (Spanish)
    Date
    November 7, 2023

    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.

    Speakers

    Speaker Image for Daniela Manzoli Bravo
    Bayer S.A. – Brazil
    Speaker Image for Hanane Abdellah
    Merck KGaA
    Speaker Image for Evangelos Kotzagiorgis
    European Medicines Agency (EMA)
    Speaker Image for Ingrid Markovic
    Genentech, a Member of the Roche Group
    Speaker Image for José Crisostomo
    ISPCH (Chile)
    Speaker Image for Emabelle Ramnarine
    Boehringer Ingelheim Fremont, Inc.

    This product is only available to members of the following groups:

    • Members