An article authored by Dr Patrick Ginty, Senior Director of Regulatory Affairs at Boyds, and Eamonn McGowran, Associate Director of Regulatory Affairs, has been published in Cell & Gene Therapy Insights’ August 2024 ‘Spotlight On’ innovation in cellular immunotherapy.

In the Regulatory Perspective article, Patrick and Eamonn explore some of the key challenges associated with the development of medical devices for the delivery of ATMPs, with particular emphasis on the evolving regulatory landscape in the EU and the technical challenges of delivering of ATMPs to challenging anatomical locations, such as the central nervous system (CNS).

Click here to read the full article in Cell & Gene Therapy Insights.

At Boyds, Patrick leads projects for our clients across the globe, providing strategic advice on complex regulatory matters with a focus on cell and gene therapy products. He has more than 17 years’ R&D and regulatory affairs experience in regenerative medicine and has worked with more than 50 cell and gene therapy products across all stages of development in the major global markets.

Eamonn supports the regulatory and quality aspects of development and launch programmes for medical devices with medico-electrical and substance components and has significant input into design dossiers, technical documentation, and the generation and management of risk files. With over 20 years’ experience of working for a range of organisations, Eamonn is a highly knowledgeable regulatory and quality professional and is also a PhD candidate at Technology University Dublin.

Contact the Boyds team to find out more about the regulatory affairs services we can provide.