PDA Singapore Chapter: Predictive Stability Webinar
Registration Options
Individual Registration
Group Registration
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
| Registration Type | Registration Fee |
|---|---|
| PDA Member | $25.00 |
| Non-Members | $50.00 |
*Prices are in USD
Day 1
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
Featured Presenters
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Andrew Lennard
CMC Regulatory Affairs, Amgen
Read BioAndrew Lennard
Amgen
Andrew Lennard is in the Global Regulatory Affairs CMC team at Amgen and is based in the UK. Within CMC Regulatory Affairs, he is part of the External Engagement and Advocacy team with responsibilities in advancing approaches to accelerate CMC in product development. Andrew has over 15 years’ experience in CMC Regulatory Affairs, with a special interest in control strategy and using prior knowledge, in which he has participated at the EMA workshops on Prior Knowledge, and on CMC acceleration in Breakthrough/PRIME. He is also an active member of EFPIA, leading several initiatives relating to CMC acceleration, including 'Stability' for which Andrew is the EFPIA topic lead on the Expert Working Group for the ICH revision of the stability guidelines. Prior to Regulatory Affairs, Andrew was a Principal Scientist in drug discovery for large pharma and small biotech start-up companies and holds a PhD from the University of Cambridge (UK).
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Paula Russell
Senior Biologist/Evaluation, Health Canada
Read BioPaula Russell
Health Canada
Dr. Paula Russell is a Sr. Biologist/Evaluator with the Centre for Blood, Blood Products, and Biotherapeutics (CBBB) in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada. She holds a PhD in Protein Biochemistry from the University of Guelph. Paula joined BRDD in 2017 and has been involved in the Quality review of CMC information for many different types of biotherapeutic products. Paula is currently serving as Health Canada's Topic Lead on the ICH Q1/Q5C Stability Guideline Expert Working Group.
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