Dawn Spiller

Company: AstraZeneca

Job title: Senior Director and Group Manager

Seminars:

Addressing Unique Challenges in Radioactive Material Compliance to Harmonize Global cGMP Standards & Enhance Regulatory Confidence for Drug Approval 1:05 pm

Navigating differing U.S. and European regulations is increasingly challenging. This workshop explores how regional GMP requirements affect manufacturing and supply chains, offering strategies to align compliance globally. Learn how early collaboration with regulators can speed up clinical supply approvals and international market entry. Join this workshop to: Uncover the regulatory differences affecting manufacturing and supply…Read more

day: Pre-Conference Workshop Day

Panel Discussion: Discussing Perspectives on Regulatory Expectations to Improve Submission Clarity & Accelerate Development Timelines 3:30 pm

Explore key differences in manufacturing practices for pharmaceutical vs industrial isotope use, including how processes, quality standards, and documentation are adapted for GMP compliance. Review common regulatory questions and challenges faced when submitting Drug Manufacturing Files (DMFs), and how these vary across agencies like the FDA and EMA. Discuss how to balance confidentiality with regulatory…Read more

day: Conference Day One