February 14, 2018
London, United Kingdom
HESI's Cell Therapy--TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to present the first workshop of the new Cell and Gene Therapy Catapult seminar series.
January 1, 2018
RISK21 Committee, 2018-2021
A list of RISK21 events from 2018-2021 can be found here: https://risk21.org/trainings-and-events/
November 29, 2017 – November 30, 2017
Buenos Aires, Argentina
Case study workshop requested by the Argentina Food Safety Network.
September 11, 2017
Bratislava, Slovakia
Join HESI at EUROTOX 2017 for a lecture on Monday, 11 September where you'll hear Dr. Louise Horsfall, University of Edinburgh speak on Synthetic biology and toxicology.
September 4, 2017
Budapest, Hungary
This satellite workshop to the 45th Annual Meeting of the European Teratology Society is addressed to participants working in industries or regulatory bodies who are involved in testing and assessment of the potential developmental toxicity of chemicals.
August 24, 2017 – August 25, 2017
Hangzhou, China
Case study workshop requested by the Chinese Food Safety Authority.
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Workshop Agenda
[Download File]
Dr. Carla Herberts, Medicines Evaluation Board, Netherlands
Regulatory Perspective (I)
[Download Presentation]
Dr. James McBlane, MHRA, UK
Regulatory Perspective (II)
[Download Presentation]
Dr. Keiji Yamamoto, Takeda/FIRM, Japan
Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods
[Download Presentation]
Dr. Yoji Sato, NIHS, Japan
In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products
[Download Presentation]
Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan
In vivo tumorigenicity testing for pluripotent stem cell-derived products
[Download Presentation]
Professor Peter Andrews, University of Sheffield, UK
iPSC genomic instability and impact on product safety
[Download Presentation]
Dr. Bill Shingleton, GE Healthcare, UK
Industry perspective
[Download Presentation]
Professor Phil Blower, King's College London, UK
Academic/Translational Perspective
[Download Presentation]
HESI’s Cell Therapy–TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to have presented the first workshop of the new Cell and Gene Therapy Catapult seminar series.
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Workshop Agenda
[Download File]
Dr. Carla Herberts, Medicines Evaluation Board, Netherlands
Regulatory Perspective (I)
[Download Presentation]
Dr. James McBlane, MHRA, UK
Regulatory Perspective (II)
[Download Presentation]
Dr. Keiji Yamamoto, Takeda/FIRM, Japan
Scheme of MEASURE, a Japanese PPP experimental consortium for standardization of tumorigenicity testing methods
[Download Presentation]
Dr. Yoji Sato, NIHS, Japan
In vitro testing methods for detection of tumorigenic cellular impurities in pluripotent stem cell-derived products
[Download Presentation]
Dr. Takatoshi Koujitani, Sumitomo Dainippon Pharma, Japan
In vivo tumorigenicity testing for pluripotent stem cell-derived products
[Download Presentation]
Professor Peter Andrews, University of Sheffield, UK
iPSC genomic instability and impact on product safety
[Download Presentation]
Dr. Bill Shingleton, GE Healthcare, UK
Industry perspective
[Download Presentation]
Professor Phil Blower, King's College London, UK
Academic/Translational Perspective
[Download Presentation]
HESI’s Cell Therapy–TRAcking, Circulation, & Safety (CT-TRACS) Committee is honored to have presented the first workshop of the new Cell and Gene Therapy Catapult seminar series.
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1. Future needs in patient safety of cell-based therapies. Identify challenges and opportunities to enhance the accuracy and efficiency of safety assessment of cell therapy products. Perspectives from a broad range of stakeholders from design to implementation settings.
2. Evolving safety tools and applied safety techniques. Learn about in vivo cell tracking approaches and their role in supporting clinical translation, as well as methods for evaluating the potential tumorigenicity risk of cell-based therapeutic products.
3. Role of collaboration in cell therapy development and use. Explore international opportunities to bridge stakeholders and improve our ability to develop and implement effective standards.
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hesi@hesiglobal.org
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