Resources
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FDA’s Approach to the Development of Cell and Gene Therapy Products
Speaker Presentation Witten Celia US FDA 2019
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Regulatory Considerations for
Analytical Development of Gene
Therapy Products
Speaker Presentation Whatley Angela US FDA 2019
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Integrated Design of Facilities and Operations for Autologous Cell Therapies
Speaker Presentation Vernon Aaron Autolus Therapeutics 2019
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Regulatory Update for Cell and Gene Therapies -Health Canada - 1
Speaker Presentation Storbeck Christopher Health Canada 2019
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Design Considerations for ATMP Premises From the EU Point of View
Speaker Presentation Rietveld Annie Rietveld Biofarmaconsultancy 2019
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Facilitating Expedited Development of
Advanced Therapy Products
Speaker Presentation Oh Steven US FDA 2019
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Regulation of ATMPs in the UK – ‘With or Without EU’
Speaker Presentation Niederlaender Christiane MHRA 2019
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Managing Accelerated Development Industry Experience
Speaker Presentation Momonoi Yoko Celgene 2019
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Comparability Approach for an Individualized Product
Speaker Presentation Kuhn Andreas Genentech 2019
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FDA Perspective on Commercial Facility
Design for Cell and Gene Therapy Products
Speaker Presentation Koo Lily US FDA 2019
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FDA’s Regulatory Perspective on Individualized Neoantigen‐specific Cancer Vaccines
Speaker Presentation Husain Syed US FDA 2019
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Regulation of Regenerative Medicine in Taiwan
Speaker Presentation Hung Wen Yi Taiwan FDA 2019
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Recent Developments in ATMP Regulation in Europe
Speaker Presentation Hoefnagel Marcel Medicines Evaluation Board 2019
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Regulatory Updates for Human Cell
Therapy Products:
An FDA Perspective
Speaker Presentation Eacho Melanie US FDA 2019
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Breaking the Traditional CMC Development Pathway
Speaker Presentation Beumer Sassi Alex Voisin Consulting 2019
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Address the Need of Standards Development in the CGT Space:
SCB & Standards Initiatives
Speaker Presentation Zhang Jiwen Tmunity Therapeutics 2018
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Process Considerations for Cryogenic Shipping
Speaker Presentation Vermeyen Craig Kite Pharma 2018
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Genetically Modified Cells: Regulatory Expectations for Marketing Authorization in Europe
Speaker Presentation Timon Marcos AEMPS 2018
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Lifecycle Management: Challenges and Lessons Learned from Kymriah™ (CD19 CAR T)
Speaker Presentation Thatcher Anthony Novartis 2018
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Comparability Studies - Unique Challenges and Key Considerations for Cell and Gene Therapy Products (CGTPs)
Speaker Presentation Taraporewala Zenobi CBER FDA 2018