About CMC Strategy Forum Latin America

Why Optimize the Submission and Review of CMC Post-Approval Changes? Global Trends and Challenges for Latin America

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 three-part virtual interactive series, 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.

Session I has been postponed from 29 March 2023 to 6 June 2023.

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Virtual Attendees

Session I has been postponed from 29 March 2023 to 6 June 2023. Join us for the virtual Session I of the 2023 CMC Conversations in Latin America from your home or office. Registration for live streaming includes a streaming only broadcast of talks and panel discussions on 6 June 2023.

Included with your registration are two follow-up sessions: Session II: 19 September 2023 and Session III: 7 November 2023. These sessions will address topics as voted on by participants in the first session. Registration will close 2 June 2023.

Registration Fees     Register for Virtual

Virtual Information

CMC Strategy Forum Latin America will include live streaming presentations on 6 June 2023. Translation will be provided (Zoom platform) for English to Spanish and Spanish to English. 

More information will be available soon.

Program Partners

Past Event Videos

  • Knowledge Sharing: Committee Member Susan Katherin Zavala Coloma Shares Her CASSS CMC Strategy Forum Experience

  • Knowledge Sharing: Committee Member Kavita Aiyer Shares Her CASSS CMC Strategy Forum Experience

  • Knowledge Sharing: Committee Member Cammilla Gomes Shares Her CASSS CMC Strategy Forum Experience

  • Knowledge Sharing: Committee Member Cecilia Tami Shares Her CASSS CMC Strategy Forum Experience

  • Knowledge Sharing: Claudia Saidman Shares Her CMC Strategy Forum Experience

  • CASSS Moments: Scientific Discussions Addressing Real-Time Issues

  • CASSS Moments: Regulatory Differences: Managing Products Globally

  • CASSS Moments: CASSS Forums Leading Scientific Discussion Over the Years

  • CASSS Moments: Discovering Hot Topics for Regulators