Rewards1: Tim, Make Sure Your CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines Effective

Tuesday, February 6, 2024

Tim, Make Sure Your CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines Effective

All training until further notice will be offered by via live stream only. You will receive further information and instructions once you have registered. The Online Training will be delivered by way of Live interactive seminars.

CfPIE Awarded 5 Year Contract by the FDA

CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines

Next Course Date
March 4 - March 7, 2024

Live Streamed Classroom

Course Director: James Blackwell, Ph.D.

As Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC, Dr. Blackwell has been a leading consultant to the regulated life science industry for almost two decades in the areas of CMC, process development, quality, laboratories, and manufacturing for all major therapeutic classes from pre-IND through commercial operations.

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Course Description

Course runs 12:00 - 5:00 ET / 9:00 - 2:00 PT

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.

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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)

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