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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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JSR Life Sciences



Headline News

FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


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Upcoming Webinars

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Past Webinars

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


Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process

Presented by Oliver Steinhof, PAT Scientist at Biogen and Martin Gadsby, Owner, Optimal Industrial Automation Ltd
06th November 2020


Raw Material Sourcing and Qualification

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
23rd November 2020


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