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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

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


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


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Upcoming Webinars

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Past Webinars

ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd, Piet Christiaens, PhD, Scientific Director and Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director at Nelson Labs
14th September 2022


New Paradigm of Building Quality during Manufacture – Challenges with Biological Products

Presented by Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC
23rd August 2017


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


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