EMA Information Day on submission predictability of initial marketing authorisation

This session examines submission predictability from the industry's perspective, highlighting the challenges and uncertainties faced during the development of a Global Submission. It will illustrate effective case studies where submission dates were adjusted while keeping all key stakeholders and regulators informed in advance. Drawing on available insights & learnings and guidance, the industry will share best practices for planning a submission, strengthening dialogue with regulators and improving predictability of submissions for all stakeholders.