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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

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


FDA approves TUKYSA regimen as front-line maintenance treatment for HER2-positive metastatic breast cancer


ICOTYDE maintains high skin clearance rates through two years in plaque psoriasis


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Upcoming Webinars

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Past Webinars

Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


Fully continuous biosimilar manufacturing framework: A case study

Presented by Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare
14th June 2018


Validation of Microbiological Methods – Expectations for Regulatory Compliance

Presented by Dr. Rajesh K. Gupta Scientific & Compliance Consultant and Alan Hoffmeister, Global Field Technical Manager for Charles River
22nd May 2015


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