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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...

Amsphere A3

JSR Life Sciences



Headline News

Astellas begins Phase III trial of setidegrasib in KRAS G12D mutated advanced lung cancer


FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


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Upcoming Webinars

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Past Webinars

Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


Mechanistic Modelling in Early Stage Chromatography Process Development for Improving Process Efficiency and Productivity

Presented by Yuyi Shen, Associate Director, Process Development and Manufacturing at Bolt Therapeutics and Nick Whitelock, Business Development Manager at GoSilico GmbH
19th April 2021


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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