Manufacturing and quality management of ATMP

Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2026064804
S$810
Original: S$2,700
Save S$1,890

About This Course

This course is an overview of the regulatory management of cell, tissue and gene therapies, providing insights and perspectives relevant to standards and requirements for the manufacture of these health innovations. The rapid pace of development of these innovations necessitates stakeholders to be equipped with a practical knowledge of the guidelines governing the manufacturing and entry into markets. This course brings together experts across the stakeholders to provide a comprehensive understanding of the regulatory requirements for manufacturing advanced therapy medicinal products that meets quality standards.

What You'll Learn

This course lays the foundational basis of product management and manufacturing of cell, gene and tissue therapies, collectively known as Advanced Therapy Medicinal Products (ATMP). It focuses on the design and development of these health innovations, covering the manufacturing aspects and its life cycle management to enhance the quality of these innovations. In this course, participants will learn about the basis of regulation for ATMP, key regulatory standards and requirements for quality control, as well as quality management systems and application in the post-approval settings.

Entry Requirements

"1. Bachelor's Degree.
2. Relevant experience in the field of health products regulation, including but not limited to cell, gene and tissue therapies"

Course Details

Duration 20.5 hours
Language English
Training Commitment Part Time
Total Enrolled New course
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