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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 places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


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Past Webinars

Applying Low Frequency Raman to QbD in Pharmaceutical Development

Presented by John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb Company and James Carriere, Product Line Manager for Coherent’s THz-Raman product line
26th April 2019


DSF and FTIR as complementary methods for the identification and characterization of vaccine products

Presented by Marina Kirkitadze, Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur and Rina Dukor, President, BioTools
18th September 2018


Key components of a comprehensive program for the management of single use technologies in biologics manufacturing

Presented by John Maguire, Shire and Donald Young, ThermoFisher Scientific
18th July 2018


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