Linan Ha

Linan Ha

Company: AstraZeneca

Job title: Director, Regulatory Affairs, CMC


Comprehending & Facing Regulatory Approval Challenges to Overcome Hurdles in ADC Scale-Up Processes 9:30 am

Exploring real life approved ADC case studies to understand the lessons learnt from adjusting processes to regulatory requirements Setting wide enough specifications for scale up, which still fall within regulatory acceptance criteria of impurity limits Understanding the regulatory frameworks for speeding up time to manufacturingRead more

day: Day One

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