Yao-Yao Zhu

Company: AstraZeneca

Job title: regulatory affairs director

Seminars:

Explore the Regulatory Expectations for Rare vs. Non-Rare Diseases 2:00 pm

Discuss how cell and gene therapy products, disease characteristics, patient population, and therapeutic goals influence the regulatory expectations Understand how regulatory agency’s approach for rare vs non-rare diseases Explore strategies to effectively demonstrate safety and efficacy in rare vs non-rare diseasRead more

day: Conference Day One

Panel Discussion: How Can We Keep Regulatory Guidelines up to Date With the Rapidly Evolving Landscape? 3:30 pm

Discovering innovative approaches and methodologies employed by industry leaders to ensure regulatory guidelines remain current in the rapidly evolving gene therapy landscape, fostering agility and responsiveness to emerging developments Exploring techniques to stay up-to-date regulatory intelligence to ensure you avoid common pitfalls Understanding the role of collaborative efforts between regulatory agencies, industry professionals, and academic…Read more

day: Conference Day One

Regulatory Expertise Q&A: Ask the Regulators 4:00 pm

This is your exclusive opportunity to utilize the regulatory experience from our panel in Health Canada & the FDA, and find out the answers to overcome your regulatory bottlenecks: Beyond the guidelines, hear Health Canada explain how to interpret the current guidelines and fill in any gaps Understand where the regulatory standards are heading in…Read more

day: Conference Day One