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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

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Headline News

Epcoritamab plus R-CHOP significantly improves progression free survival in newly diagnosed diffuse large B-cell lymphoma


FDA review of Novo Nordisk’s denecimig for haemophilia A runs longer as manufacturing facility remediation continues


Giredestrant and everolimus significantly extend progression free survival in ER positive advanced breast cancer in phase III evERA results published in The New England Journal of Medicine


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Past Webinars

End User Perspective on Setting in-Process Endotoxin Limits

Presented by Dr Friedrich von Wintzingerode, Roche/Genentech
15th May 2018


Innovative solutions from Industry 4.0

Presented by Michael May, PhD, President and CEO, CCRM at Centre For Commercialization Of Regenerative Medicine and Philip G. Vanek, PhD, General Manager, Cell and Gene Therapy Strategy at GE
10th June 2019


Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux
23rd May 2019


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