OVERVIEW

Chemistry, Manufacturing & Controls (CMC) Regulatory Compliance Strategy for Cell & Gene Therapy Medicines is organized by The Center for Professional Innovation & Education (CfPIE), Inc. and will be held from Nov 16 - 19, 2026.

Description:
This 20 hour course is designed for life sciences professionals involved with the cell and gene therapy manufacturing process for medicines (also referred to as ATMPs, Advance Therapy Medicinal Products) looking to develop an effective risk-based Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy for these unique living medicines.

The full spectrum of CMC, GMP and Quality activities across the pathway of clinical development will be applied to the unique requirements of cell and gene therapy manufacturing processes and products. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed within the context of cell therapy companies and their regulatory requirements.

Learning Objectives
At the end of the three-day course attendees will:

Gain a solid understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH) for Cell & Gene Therapy medicines during clinical development and market approval
Have the tools and understanding to develop and carry out an effective CMC regulatory compliance strategy for the company’s CGT product(s)
Understand the strengths and limitations of Quality by Design (QbD) and Quality Risk Management (QRM) for Cell & Gene Therapy manufacturing processes
Learn how to avoid major delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy.