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Katja Sirviö, M.Sc. (Pharm.) - Scholarship recipient of the 2021/2022 ISCT Europe Scholarship and the Master in Manufacturing of ATMPs

  

Scholarship recipient of the 2021/2022 ISCT Europe Scholarship and the Master in Manufacturing of ATMPs


Katja Sirviö, M.Sc. (Pharm.)
Cell Therapy Process Development Manager
Kuopio Center for Gene and Cell Therapy (KCT), Kuopio, Finlandanager

The Master degree in Manufacturing of Advanced Therapy Medicinal Products (ATMP) program, provided by the Andalusian Initiative for Advanced Therapies together with the University of Granada, and sponsored by ISCT-EU and Miltenyi Biotec, is a very comprehensive and worthwhile study program. It combines an online, e-learning platform for sharing up-to-date study materials and allowing interactive communication between the teachers and students, with intensive practical training, in the cleanrooms of IAVANTE in Granada, Spain.

The flexibility of the online theoretical sessions fitted very well into my daily working activities as Cell Therapy Process Development Manager. The course started with an introduction to the regulations concerning ATMPs giving an important view of the developmental roadmap from bench to bedside, followed by modules teaching the principles, development, manufacturing, and clinical use of the three main ATMP categories – gene and somatic-cell therapy, and tissue-engineered medicines. Importantly, the theoretical modules included all available and valid guidelines for ATMPs, covering good manufacturing practice (GMP), quality, biosafety, non-clinical and clinical aspects of ATMPs, Investigational medicinal product dossier (IMPD), and common technical document (CTD) and concluded by giving a view of the current status of ATMPs, and where the field is heading to. The majority of these sections contained versatile and useful case studies, lively communication, and an exchange of experiences online.

The practical module for the specialization of Manufacturing Manager contained 1.5-weeks of on-site training on manufacturing process of an investigational cell therapy medicinal product, after which the final project was about the fulfillment of manufacturing aspects of an investigational medicinal product dossier. I found the practical training section very valuable as working in the GMP facilities alongside experienced teachers and other students from different countries enabled viable discussions, effective sharing of experiences, application of the theory into practice, and importantly, networking with people working in the fascinating, promising and, challenging field of ATMPs.

For my professional career, these studies and timing were a real match. The program has equipped me with practical knowledge of working with regulatory authorities, CDMOs, clinicians and other parties. Learning alongside peers who are working in ATMP sector throughout Europe was extremely valuable as it allowed us to share technical, scientific, and regulatory know-how from different European perspectives and I’m sure these new connections will continue to prove to be valuable in the future. I am now taking the knowledge and skills I gained through this course and using them to train and upskill other members of my team.  

I sincerely recommend this Master Programme for people working in the fields of ATMP and Regenerative Medicine

Katja Sirviö, M.Sc. (Pharm.), Master in Manufacturing of Advanced Therapy Medicinal Products, specialization as Manufacturing Manager

Awardee of the inaugural ISCT Europe Master Programme Scholarship 2021/2022

Cell Therapy Process Development Manager

Kuopio Center for Gene and Cell Therapy (KCT), Kuopio, Finland

 


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