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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

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


Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


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

Application of Next Generation Sequencing (NGS) Based Methods for Detection of Viral Contaminants in Biomanufacturing

Presented by Jurgen Mullberg Associate Director at Bristol Myers Squibb and Joanna Zmurko, NGS specialist at PathoQuest
21st October 2021


Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech
20th November 2019


PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche
03rd May 2019


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