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Singapore’s New Cell, Tissue and Gene Therapy Products …

WEBSingapore’s New Cell, Tissue and Gene Therapy Products Regulations. Home / Papers and Presentations / Resource. In This Section. Papers and Presentations. Share this article: …

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URL: https://www.casss.org/papers-and-presentations/resource/speaker-presentation-singapore-s-new-cell-tissue-and-gene-therapy-products-regulations

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WEBCelia M. Witten, Ph.D., M. D. is the Deputy Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA/CBER).

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Emergence and Advancement of Technologies: Regulatory

WEBRegulation of Gene and Cell Therapy Products in Canada (cont’d) Cell and Gene Therapeutic Products. Regulated as Biologics, in Schedule D (Biologic Drugs) of the …

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Microbial Challenge In-use Studies

WEBSpeaker Presentation Leiske Seagen Inc. Zamiri Genentech 2022 Microbial Challenge In-use Studies - Industry efforts to harmonize strategies in collaboration with Health …

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Project ORBIS: Opportunities and Challenges from the CMC …

WEBParticipation by both Biologic and Radiopharmaceutical Drug Directorate (BRDD; biologics) and Therapeutic Product Directorate (TPD; small molecules) Products are either new …

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Health Canada: Update on Regulatory Activities & Priorities

WEBRegulatory Priorities Examining our review system to determine the best approaches to: • better respond to healthcare system needs, and • improve timely access to effective …

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Health Canada Implementation of ICH Q12: CMC Changes

WEBIntroduction of the Level III – Immediate Notification reporting category will allow the notification of changes in a timely manner of the changes that have been …

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Advanced manufacturing and other trends supporting access …

WEBIn 2022, 44 “New Active Substances” were approved, an increase from 2021. Half of drugs approved by Health Canada in 2022 were for rare diseases. Over the past 6 years, over …

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Multiproduct Facility Design and Control for Biologics

WEB2 BioProcess International 10(11)s De c e m b e r 2012 Fl e x-Facilities Design Multiproduct Facility Design and Control for Biologics Challenges and Considerations Bo Chi, Julia …

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Wassim Nashabeh Announced as CASSS Hancock Award Winner …

WEBNashabeh was announced as the 2024 honoree during CASSS’ Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health …

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Lessons Learned: Compatibility and In-Use Stability Studies

WEBA potency assay might be the only viable approach to assess protein concentration and drug product degradation for dilute products. other methods may not be sufficiently …

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Table 3: Host Cell Proteins Identification, Strategies

WEBTable 3: Host Cell Proteins – Identification, Strategies, Successes and Challenges Facilitators – Dawn Kelly, Merck & Co., Inc. Mark Paciga, Merck & Co., Inc. Scope: Host …

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January 24, 2023

WEBMicrosoft Word - WCBP 2023 Final Program. 08:00 - 08:30. CASSS Welcome and the 11th Annual William Hancock Award. Presented by: Julia Edwards, Genentech, a Member of …

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Microbial Challenge In-use Studies- Industry efforts on …

WEB| 5 Proprietary Microbial challenge studies evaluate potential for microbial growth • Holding product after breach of sterility represents a risk, in-use storage time …

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Regulation of Medicines and Biological Products in Perú

WEBin Review. Art. 36° Pharmaceutical product changes. Supreme Decre: 011-2016-SA (Biotecnological products) Supreme Decre: 011-2016-SA (Biosimilar products) …

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Phase Appropriate GMP Expectations for Analytical Methods …

WEBPhase Appropriate Expectations for Analytical Methods and Process Validation for Expedited Programs: A Regulatory Perspective Megan Powdrill, Ph.D –Biologist/Evaluator

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