Resources
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Global CMC Convergence: an FDA Perspective
Speaker Presentation Schultz Kimberly, CBER, FDA, 2021
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Potency Assay Development Cell-based Therapy for Cartilage Repair
Speaker Presentation Roël Giulietta, CO.DON AG, 2021
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Product Structural Characterization for AAV-based Gene Therapy Development
Speaker Presentation Pu Yi, Biogen, 2021
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Autologous Cell Therapy Phase Appropriate Control Strategies from Early Clinical Development to Commercialization
Speaker Presentation Polson Nolan, Bristol-Myers Squibb Company, 2021
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Facilitating Advanced Technologies in Cell and Gene Therapies
Speaker Presentation Oh Steven, CBER, FDA, 2021
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BLA Post-Approval Case Studies for Oncolutic Virus, IMYGIC® (TALIMONGENE LAHERPAREPVEC)
Speaker Presentation McQueen Jocelyn, Amgen Inc., 2021
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Singapore’s New Cell, Tissue and Gene Therapy Products Regulations
Speaker Presentation Kellathur Srinivasan, Health Sciences Authority, 2021
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Regulation of Cell and Gene Therapies in Australia
Speaker Presentation Hislop Andrew, Therapuetic Goods Administration, 2021
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Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (BGTC)
Speaker Presentation Hoffman Steve, The Foundation for the National Institutes of Health, 2021
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Overcoming the Challenges Getting ATMPs Approved in the European Union
Speaker Presentation Celis Patrick, European Medicines Agency (EMA), 2021
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Emergence and Advancement of Technologies: Regulatory Challenges and Considerations
Speaker Presentation Haile Yohannes, Health Canada, 2021
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ATMPs in the UK: Routes to Market and Avoiding “Trees on the Track”
Speaker Presentation Bisset Louise, MHRA- Medicines and Healthcare Products Regulatory Agency, 2021
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Trending MS Topic via Attendee Polling - Analytical Mass Spectrometry Challenges with New Modalities
Roundtable 12 Notes: Mass Spec 2021
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mRNA Characterization by MS – What Are the PQAs and What Are the Methods
Roundtable 11 Notes: Mass Spec 2021
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Successful Implementation of Top/middle Down MSMS for Characterization
Roundtable 10 Notes: Mass Spec 2021
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Best Practices for Reporting MS Data in Regulatory Filings
Roundtable 9 Notes: Mass Spec 2021
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MS of RNA and Oligonucleotides - Minimizing Adducts and Quantitation Best Practices
Roundtable 8 Notes: Mass Spec 2021
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MS Data Analysis - Feedback and Suggestions to Improve Software Tools
Roundtable 7 Notes: Mass Spec 2021
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Structural MS - New Developments in Limited Digestion, HDX, FPOP and Ion Mobility
Roundtable 6 Notes: Mass Spec 2021
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Best Practices for Predicting, Elucidating and Monitoring Hotspots by MS
Roundtable 5 Notes: Mass Spec 2021