Navigating the New EU HTA Regulation as an MAH: Strategic
Insights for Successful JCA Submissions

Explore how the EU HTA regulations are impacting JCA submissions, and ultimately market access
and Marketing Authorization Holders (MAH)

Date: November 18, 2025

Time: 10:00-11:00 AM US EST / 4:00-5:00 PM CEST

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About the Webinar

As Europe enters a new era of Health Technology Assessment (HTA), the implications of the EU HTA Regulation (EU HTAR) are reshaping how medicines reach patients across the continent.

With the EU HTA Regulation eventually set to apply to all new medicines that are going through a centralized Market Authorization Approval (MAA) at the European Medicines Agency (EMA), Marketing Authorization Holders (MAHs) face a new set of requirements and expectations. For MAHs, this change raises critical questions: How will Joint Clinical Assessment (JCA) submissions impact market access strategies? What evidence and planning will be needed to meet both procedural and evidentiary expectations under the new JCA framework? 

This session will unpack the evolving EU HTAR landscape — from understanding the JCA framework to developing strategies for successful dossier preparation. Through practical insights and real-world considerations, we’ll explore how MAHs can position their products for positive JCA outcomes, avoid common pitfalls, and anticipate downstream effects on national pricing and reimbursement.  

Whether you're preparing your first JCA submission or refining your market access strategy for future launches, this webinar will equip you with the tools needed to navigate the new EU HTAR system with confidence. Don't miss the chance to stay ahead in a rapidly changing HTA environment that directly impacts market access across Europe. 

What You’ll Learn

  • What the JCA framework looks like under the new EU HTA Regulation 
  • Strategic approaches to JCA dossier preparation to maximize European market access success
  • Insights into JCA dossier impact on national-level pricing and reimbursement in European markets 

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

Meet the Speaker

  • Katarina Ericson Bio Photo

    Katarina Ericson

    Associate Director, Pricing and Reimbursement

    View Bio

Katarina holds an M.Sc. in Health Economics from Karolinska Institutet, where she built a strong foundation in pharmaceutical sciences, pharmacoeconomics, and healthcare systems. She currently serves as Associate Director in Pricing and Reimbursement, based in the Stockholm Metropolitan Area. Her work focuses on designing and executing market access strategies that ensure new therapies are both affordable and accessible. With prior experience as an HTA assessor at a national agency and involvement in European-level evaluations through EUnetHTA, Katarina brings deep expertise to her role at ProPharma. She excels in preparing HTA submissions, conducting market analyses, and engaging with health authorities to secure favourable outcomes. Katarina emphasizes early dialogue with assessors to build robust dossiers that meet regulatory and economic standards. Her strategic insight is vital for companies aiming to achieve timely market entry and sustainable pricing across Europe.