Join our experts for part one of our EU regulatory strategy webinar series for an interactive discussion focused on mastering the Marketing Authorization Application (MAA) process.

Securing marketing authorization in Europe requires a deep understanding of regulatory pathways, dossier structure, and evolving EMA expectations. In this interactive webinar, our regulatory experts will walk you through proven, regulator-ready strategies to strengthen your MAA submission—reducing clock-stops, validation defects, and approval delays.  

This session will provide actionable insights for navigating every stage of the submission process, from intelligent procedure selection and early scientific advice to airtight Module 3 documentation, benefit–risk narratives, and final labeling coordination. Plus, submit your questions now for our experts to answer during the live session! Our goal is to make this as interactive as possible, so we will also take live questions during the webinar to ensure you are able to get the answers you need.

Attendees will learn how to: 

• Choose the optimal route (CP, MRP, or national) and plan for PRIME, Orphan, PIP, and HTA convergence.
• Build a “no-surprises” dossier through strong eCTD hygiene and Module 1 country-specific readiness.
• Strengthen CMC quality and comparability narratives to avoid Day 120 questions.
• Craft persuasive clinical efficacy/safety stories that withstand CHMP scrutiny.
• Minimize delays with targeted RFI planning, labeling alignment, and mock Q&A preparation.

Unable to join? Register and you will receive the recording after the live session.

Make sure you register for part two of the series on EU regulatory strategy, where we will explore how the EU HTA regulations are impacting JCA submissions, and ultimately market access and Marketing Authorization Holders (MAH).