Pre-Conference Workshop Day
Tuesday 3rd September 2024

8:00 am Check-In & Coffee

9:00 am Workshop A

Advancing Cell Therapy: Standardising Analytics and Reference Materials

  • Andreea Iftimia Mander Head of Analytical & Biological Sciences, Medicines & Healthcare products Regulatory Agency
  • Vinoy Ramachandran Head of NGS and Bioinformatics, Medicines & Healthcare products Regulatory Agency

Synopsis

  • Discuss the MHRA's role in developing and implementing regulatory standards for analytical methods and reference materials in cell therapy R&D
  • Highlight the importance of standardisation in analytical development to ensure consistency, reliability, and comparability of data across different studies and manufacturing processes
  • Explore how standardised analytics and reference materials support innovation while maintaining the safety and efficacy of cell therapy products, ultimately advancing the field and benefitting patients

12:00 pm Lunch Break & Networking

1:00 pm Workshop B

Navigating the Analytical Lifecycle: Strategic Management for Streamlined Product Development

Synopsis

  • Discuss the stages of the analytical lifecycle from method development and validation to routine testing and continuous improvement. Explore the importance of establishing clear milestones and objectives at each stage to guide the management of control measures effectively
  • Explore best practices for strategically placing control measures throughout the analytical lifecycle to ensure data integrity, method robustness, and regulatory compliance. Highlight key control points such as method validation, instrument qualification, sample handling, and data management, emphasising the need for risk-based approaches and proactive monitoring
  • Emphasise the importance of continuous monitoring and adaptation of control measures to address emerging risks and changing requirements throughout the analytical lifecycle. Discuss strategies for implementing real-time monitoring systems, periodic review processes, and corrective actions to maintain the effectiveness of control measures and optimise analytical workflows

4:00 pm End of Workshops