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DE&I and Unconscious Bias
Roundtable 13 Notes: Cell & Gene Therapy Products 2023 -
CQA Risk Assessments for Cell and Gene Therapies
Roundtable 9 Notes: Cell & Gene Therapy Products 2023 -
Comparability for Cell and Gene Therapy Products
Roundtable 3 Notes: Cell & Gene Therapy Products 2023 -
CGTP 2023 Keynote Speaker Summary
Summary Simran Kaur CARGO Therapeutics, Inc.
Speaker Presentation Schweighardt Becky Grace Science LLC 2023 -
Accelerating CMC Review in PAC: ANVISA’s Online Optimized Assessment Project
Speaker Presentation Blades Carolina Brazilian Health Regulatory Agency (ANVISA) 2023 -
Global Trends in Lifecycle Management
Speaker Presentation Hamel Hugo Health Canada 2023 -
Reliance for Post-approval Changes: an Industry Perspective
Speaker Presentation Roman Maria Antoineta Latin American Federation of the Pharmaceutical Industry - FIFARMA 2023 -
Analytics for Process-related Impurities in Viral Vector Manufacturing
Speaker Presentation Zilberman Alla Cygnus Technologies FDA 2023 -
Regulatory Perspectives on Gene Therapies Incorporating Human Somatic Genome Editing
Speaker Presentation Ye Zhaohui FDA 2023 -
Defining Microbial Control Strategies for Cell-Free and Cell-Based Individualized ATMPs
Speaker Presentation Von Wintzingerode Friedrich Genentech Roche 2023 -
USP Evolving Position on Use of Rapid Microbial Methods
Speaker Presentation Tu Huiping USP 2023 -
Gene Therapy Drug Development for Ultra-Rare Disease: Challenges & Opportunities
Speaker Presentation Schweighardt Becky Grace Science LLC 2023 -
Donor Qualification and Procurement of Allogeneic Cellular Starting Material: A Global Regulatory Perspective
Speaker Presentation Schuster Jared NMDP 2023 -
What Device Engineers Can Teach You About CGTP Delivery Devices
Speaker Presentation Baskaran Saran and Shah Samir AstraZeneca 2023 -
U.S. FDA’s Perspective on Delivery Devices Used to Administer Cell and Gene Therapy Products
Speaker Presentation Ricles Laura FDA 2023 -
The Regulatory Interface of ATMPs and Medical Devices in Europe
Speaker Presentation Reischl Ilona AGES MEA 2023 -
Decentralised and Point of Care Manufacturing - A UK Perspective
Speaker Presentation Rees Ian MHRA 2023 -
INDUCE-seq: Ensuring the Safe Development of Cell and Gene Therapies by Gene Editing
Speaker Presentation Reed Simon Cardiff University 2023 -
Epigenetic Editing: New Frontier for Genetic Medicines
Speaker Presentation Poudel Raj Tune Therapeutics 2023 -
Delivering Next Generation Cell Therapy Manufacturing Faster without Compromising Quality
Speaker Presentation Nichols Scott Kite Pharma 2023