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Navigating Through the ATMP Guidance and Regulations

Date
May 13, 2025
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This conference seeks to examine the application of the latest technological advancements such as artificial intelligence (AI) and machine learning, virtual and augmented reality, and smart manufacturing, as well as innovations relating to biopharmaceuticals and ATMPs…

ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as 'Personalised Medicines'. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived compounds (small molecule), or proteins or peptides expressed as cellular systems (large molecule). It is not surprising that there are regulations and guidance specifically for ATMPs such as EudraLex Volume 4, Part IV (EMA), and PIC/S Annex 2A. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. Learn how to navigate through some of these differences including when and how to apply EudraLex Annex 1 (Manufacture of Sterile Medicinal Products), ICH Q9 (Quality Risk Management), and ICH Q5 (viral safety evaluation).

Speakers

Speaker Image for Jon Halling
Managing Director for Quality, Catapult Cell and Gene Therapy
Speaker Image for Alfred Penfold
Technical Director - GMP / Regulatory Compliance, PM Group

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