Guzin Sahan
Associate Director, CMC Regulatory Affairs AstraZeneca
Guzin Sahan is a CMC regulatory affairs professional with over 20 years of experience, currently working in global CMC regulatory affairs function as Associate Director at AstraZeneca, where she leads global CMC strategy and execution for regulatory submissions across global markets. Specializing in both clinical and commercial applications—particularly biologics in oncology—she collaborates with cross-functional teams on CMC strategy development. Guzin is skilled in addressing evolving regulatory requirements and driving process improvements to ensure compliance and successful product registrations.
Seminars
Join this closing roundtable session with leaders in ADC regulatory CMC field to break down the key learnings from the seminar day. With your fellow speakers and attendees, discuss, debate and evaluate the opportunities and challenges in ADC regulatory CMC guidance, analytical control strategy, creating development packages, and more.
- Leveraging agency feedback focusing on clinical submissions, highly relevant for sponsors navigating evolving requirements for ADCs
- Providing case examples of successful navigation or challenge resolution in early-phase ADC CMC filings
- Breaking down takeaways from case study analyses to aid sponsor interpretation and application of global regulatory standards for ADCs
By blending small and large molecule components, and more complex conjugates on the horizon, ADCs present additional hurdles and considerations to ensure a robust regulatory CMC strategy and best set up ADC regulatory submissions for success Exploring sponsor and regulator perspectives, don’t miss these important sessions laying out ADC regulatory CMC fundamentals, providing technical insights for impurity control strategy, and assessing regulator expectations and feedback to elevate your ADC regulatory CMC knowledge base
