Mahwish Natalia
Company: Takeda Oncology
Job title: Associate Director
Seminars:
Contrasting FDA vs EMA Experiences to Cement European Regulatory Strategy 9:05 am
One of the biggest challenges is navigating the regulatory frameworks, especially with FDA holds on release and potency assays. This workshop will explore the contrasting experiences of these two regulatory bodies, and provide insights into the challenges of assay development and validation in cell therapy potency testing. Attend this workshop to: Identify the challenges of…Read more
day: Pre-Conference Workshop Day
Establishing Reference Materials & Quality Control Attributes for Potency Assays of Cell Therapies 9:00 am
Understanding the regulatory expectations and guidance for establishing reference materials and reference methods in cell therapy potency assays Exploring the validation and qualification requirements for orthogonal methods to improve potency assays Discussing the challenges and best practices in establishing quality control attributes for cell therapy potency assaysRead more
day: Conference Day One