Navigating Global Regulatory Variations in Decentralized Cell Therapy Manufacturing

Time: 1:30 pm
day: Pre-Conference Workshop Day


With new regulatory guidance for decentralized manufacturing set to come into effect, it is essential that all cell therapy leaders have a solid understanding of the regulatory requirements across various regions to ensure that the development of cell therapies continues to adhere to quality and safety standards.

Uncover intricate nature of varying global regulatory requirements in a decentralized manufacturing setting and develop strategies to navigate diverse regulatory landscapes while preserving safety and quality.

This workshop will cover:

  • Outlining the complexities of varying regulations across different countries and regions for decentralized manufacturing
  • Exploring effective strategies to address diverse regulatory landscapes while maintaining product quality and patient safety
  • Discussing ongoing efforts towards harmonizing regulatory standards globally to ensure product quality is consistent across all sites
  • Addressing the challenges of complying with multiple regulatory frameworks and exploring practical solutions to ensure adherence to safety and quality standards