Learn how to develop and manufacture cell and gene therapies that meet regulatory requirements
Learn how to develop and manufacture your cell or gene therapy product in a way that enables fast approval by the health authorities.
Advancnal Products, ATMPs (also known as cell and gene therapies) represent a new generation of medicines designed to repair, replace, or modify cells or genes to treat or even cure diseases. These innovative products are transforming modern medicine — but their development and manufacturing are governed by complex regulatory requirements.
To bring these advanced therapies safely and efficiently to patients, companies must ensure these products are developed and manufactured in accordance with the requirements from the health authorities. This includes understanding how ATMPs are defined and classified, how the product and process must be developed, and how Good Manufacturing Practice (GMP) principles apply from early development through to market approval.
This course gives you a clear roadmap for how to develop and manufacture your ATMP in a way that meets regulatory CMC (Chemistry, Manufacturing, and Control) and GMP requirements from early development to market approval. You will learn how to use the Quality by Design framework to define critical quality attributes, establish control strategies and build scientific justification for your regulatory submissions.
Through interactive lectures and case discussions, you will gain insight into navigating the regulatory landscape and develop and manufacture your ATMP in a way fulfills the expectations by the health authorities hereby supporting a smooth approval of your clinical trial or marketing authorisation application.
The course language is English.
At the course you will meet:Erik Steffensen, Managing Partner and Principal Consultant, Spot-on Pharma Consulting
