About This Event
The Asia-Pacific region is witnessing rapid advancements in the field of gene therapies, offering promising avenues for the treatment of various diseases. However, ensuring the safety, efficacy, and quality of these innovative therapies relies heavily on the quality of critical raw and starting materials used in their manufacturing processes.
The U.S. Pharmacopeia (USP) and Northeastern University (NEU), as an Asia-Pacific Economic Cooperation (APEC) Center of Excellence for Biotherapeutics and Advanced Therapies and Priority Work Area Champions, are hosting a training program focused on the qualification of raw and starting materials for gene therapies. This training aims to foster dialogue, collaboration, and capacity-building among regulators and stakeholders to address the evolving regulatory challenges and opportunities in this rapidly advancing field.
Learn more about topics such as:
- Raw material expectations from different regulatory bodies
- Selection and source of materials
- Case studies
- Lifecycle management of raw materials in advanced therapy products
Join us to gain critical insights and contribute to shaping the future of gene therapy regulation in the Asia-Pacific region. The registration is free and exclusive for APEC regulators.
This event is for regulators only.
Date and Time
September 29-30, 2025
Location
Marriott Dongdaemun, Seoul, Republic of Korea
Cost
Free
Register Now
Secure your spot today to join leading regulators in Seoul for critical training on the qualification of raw and starting materials for gene therapies in the Asia-Pacific region.
By the end of the workshop, participants are expected to gain a deeper understanding of the challenges and best practices related to the qualification of raw materials for gene therapies, as well as identify opportunities for regulatory harmonization and collaboration to support the development and access to gene therapies in the Asia-Pacific region.
