PDA Singapore Chapter: Predictive Stability Webinar

Virtual

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Please join us for this exciting webinar where we will unveil the evolution of predictive stability with our expert presenters. During this webinar, our presenters will focus on the following key points:

  • Progress in developing predictive stability models for changes in quality attributes through shelf-life and use of prior knowledge for therapeutic proteins such as monoclonal antibodies for establishing shelf-life beyond the available real-time data
  • Regulatory expectations for using prior knowledge and statistical models in product stability, focusing on justifying the approach and model suitability

Key Topics: Progress in Developing Approaches to Predictive Stability Modelling for Biological Medicinal Products

Agenda

Discover What's Happening Each Day
Day 1 03 Jul
Wednesday, 3 July

2:00pm - 2:10pm | Opening Address, Lin Pao Chun, Member at Large, PDA and QC Manager, GSK

2:10pm - 2:50pm | Progress in Developing Approaches to Predictive Stability Modelling for Biological Medicinal Products, Andrew Lennard, PhD, Regulatory Affairs CMC, Amgen

2:50pm - 3:30pm |Modelling for Product-Specific Stability: A Regulatory Perspective, Paula Russell, PhD, Senior Biologist/Evaluation, Health Canada

3:30pm - 4:00pm | Q&A

Registration

Pricing Options
Registration TypeRegistration Fee
PDA Member$25.00
Non-Members $50.00

*Prices are in USD

 

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