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ISPE Emerging Leaders - ATMP Online Seminar Series - Vol I.

Advanced Medicinal Therapeutical 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.

For more information on the upcoming sessions, subscribe to our newsletter by checking the box in the registration form or follow us on LinkedIn.

Program - Vol I. - 13.09.2022

Time	Presenter	Topic
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

My name is Jérôme Toussaint and I am the MSAT Knowledge Manager at CTLT Gosselies. I am currently working on the scientific data and knowledge management about this amazing field which is cell therapy.

Regarding my education, I’m a Biologist and I did a PhD in Breast Cancer research, identifying the genomic signature of this type of cancer to improve patient’s diagnosis and treatment.

My professional experience began, as a teacher prior to working in the vaccine industry, for almost 10 years. During this exciting period, I started in the production department : implementing new automatized process in manufacturing unit, and, afterwards, I transitioned to the QA department, setting up and starting a new production building and managing the Quality audit.

Viridiana Urena

My name is Viridiana Urena working as an MSAT Engineer at CTLT Gosselies. I am currently working on analytical method validation on cell and gene therapeutics. Previously I worked as ExCellThera, a cell therapy start-up in Montreal, as the first QA member where I started to set up the Quality Management System of the company and managed GMP quality events and GCP audits. I previously worked at Caprion Biosciences (now CellCarta) where I supported testing of clinical samples for cell therapy products as well as the validation of analytical methods for viral vaccines both in Montreal and Belgium. During this time I obtained my Lean Six Sigma Green Belt Certification. I started my first job in the pharmaceutical field working on the development of assays for IVIGs for infectious diseases (Zika and Influenza). I have a MSc in Microbiology and a BSc in Biotechnology from the University of Manitoba. I speak fluent English, French and Spanish.

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

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Organizer of this event:
ISPE D/A/CH e.V.
c/o Refidar Moore Stephens AG
Herr Lattmann

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