Chair:
- Elsa Abranches, PhD, AstraZeneca, Sweden
Speakers:
- Jonathan Campbell, PhD, MetBio Scientific Consulting, United Kingdom - Unlocking a grand challenge? Key standards considerations for comparability of cellular assays and process analytics
- Peter Crowley, BSc(Hons), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom - The role of standardisation to ensure process robustness and product efficacy and safety
- Ivana Knezevic, PhD, World Health Organization (WHO), Switzerland - Standardization of Advanced therapy products: WHO approach
This session delves into the pivotal role of standardisation in ensuring the robustness of processes and the efficacy and safety of products throughout their life cycle. It emphasizes collaboration among developers, standardisation agencies, and regulators to achieve successful commercial production and delivery. The session will cover a range of topics, including views on the development of practical validation tools for the design and delivery of Advanced Therapy Medicinal Products and strategies to enhance their global availability and accessibility. Attendees will gain insights into the importance of standardisation for universal health coverage and the collective efforts required to ensure global access to high-quality healthcare products.
Session Objectives
- Understanding the Importance of Standards in Cellular Assays and Process Analytics.
- Exploring the Role of Standardization in Process Robustness and Product Efficacy and Safety
- Assessing the Global Approach to Standardization of Advanced Therapy Products
