Skip to main content
RAPS Euro Convergence 2026 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
RAPS Focus
RAPS Focus
Networking Opportunity
Networking Opportunity
Ticketed Event
Ticketed Event
Student Focus
Student Focus

Ines Lenic, MSc

Regulatory Affairs Director - EU
AstraZeneca, United Kingdom

Ines Lenić is EU Regulatory Affairs Director at AstraZeneca, working in Global Regulatory Affairs for Oncology R&D. She has over seven years of regulatory experience spanning early stage development through marketing authorization, concentrating on EU oncology regulatory science and strategy. She holds a Master’s in Pharmacy (University of Zagreb) and an MSc in Regulatory Affairs (University of Hertfordshire). Prior to AstraZeneca, she trained for a year at the European Medicines Agency, deepening her understanding of the European regulatory environment and inter‑agency collaboration. Her interests include international reliance and work‑sharing approaches that can streamline submissions and advance harmonisation. She will present the industry sponsor’s perspective on FDA’s Project Orbis, with case studies that surface practical opportunities, challenges, and routes to accelerated approvals and access.

Presentation(s):