Advanced Therapy Medicinal Products (ATMPs) represent a rapidly evolving field within the pharmaceutical industry, comprising of gene therapy, cell therapy, and tissue-engineered products. These innovative medicinal products offer the potential to treat, and even cure, conditions that are currently untreatable with conventional medicines. However, the complexity of ATMPs brings unique challenges, including unconventional regulatory requirements, intricate manufacturing processes, and the need for specialized knowledge in quality control and clinical applications. As ATMPs move from research to commercial application, there is a critical need for industrial pharmacists in Thailand to understand the landscape, including the latest advancements, regulatory pathways, and practical considerations for the development and commercialization of these therapies.

The learning objective of this talk is to provide participants with a comprehensive overview of Advanced Therapy Medicinal Products (ATMPs) including,
1. Define the basic concepts and categories of ATMPs, including gene therapy, cell therapy, and tissue-engineered products, and distinguish them from traditional pharmaceuticals.
2. Understand the current regulatory framework governing ATMPs, identifying key differences and unique challenges compared to traditional drug regulations.
3. Identify the manufacturing challenges and quality control measures unique to ATMPs, with an emphasis on cell and gene therapy products.

ATMP, Advanced Therapy Medicinal Products

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