Advanced Therapy Medicinal  Products

The ISPE Emerging Leaders invite you to join our online seminar series 2022. In multiple volumes, you will learn about ATMP related topics. We will cover the basics of cell and gene therapy and tissue engineering, new manufacturing processes and the implications of these novel products on engineering and regulatory aspects.

This event is a joint initiative of the ISPE Emerging Leaders groups of the D/A/CH and Belgium affiliate.

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Program – Vol I. – 13.09.2022

17:30 – 17:40 ISPE Emerging Leaders – Welcome by the moderators and introduction to ISPE Emerging Leaders and the seminar series
17:40 – 18:10 Jasna Curak (Roche) – Advanced Medicinal Therapeutic Products (ATMP) and associated GMP challenges
18:10 – 18:40 Jérôme Toussaint and Viridiana Urena (Catalent) –  Introduction to Cell and Gene Therapy and T-cells manufacturing overview at Catalent
18:40 – 19:30 All – Open Q&A with possibility to network with other participants

More information about the speakers

Jasna Curak
Jasna is part of Roche Global Compliance and External Collaboration, regulatory intelligence for ATMPs, GMP considerations, currently working with ISPE ATMP community of practice, active in drafting position papers and commenting lead for global regulatory landscape. Previous to this, she was in Production Management in large scale manufacturing facilities for vaccine manufacturing, and GMP maintenance lead, supporting a reliable and robust process integrated with strong quality infrastructure.

Jasna holds a master’s degree in Molecular Genetics from the University of Toronto, and a bachelor’s degree in Biochemistry, Molecular Biology from McMaster University, Canada.

Jérôme Toussaint and Viridiana Urena

Jérôme Toussaint is a Senior Knowledge Manager at Catalent Belgium. Viridiana Urena is a MSAT engineer at Catalent Belgium.