Webinar: Develop Once, Access Europe: The Power of Joint Clinical Assessment (JCA)

At Parexel, we're committed to guiding you through the evolving European regulatory landscape. Join us as we delve into the Joint Clinical Assessment (JCA) process and its profound impact on market access strategies.

Local time zones for webinar:

11:30 IST - New Delhi
14:00 CST -  Beijing
15:00 JST - Seoul, Tokyo
16:00 AEDT - Sydney

Why Attend?

Understanding and adapting to JCA is crucial for success in the European market. This webinar will equip you with actionable insights to navigate this new paradigm effectively.

Key Topics:

1. Introduction to JCA
   • Understand the fundamentals and implications of JCA
   • Learn how JCA is reshaping the European regulatory landscape
2. HTA-proofing Development
   • Discover how JCA impacts early trial design
   • Strategies for aligning clinical development with HTA requirements
3. Beyond Efficacy: Integrating Value into EMA Assessment
   • Learn techniques for incorporating value propositions into regulatory submissions
   • Understand how to balance efficacy data with value demonstrations
4. Bridging the Gap to HTA Acceptance
   • Explore strategies to align regulatory approvals with HTA expectations
   • Learn how JCA can streamline the path from EMA approval to HTA acceptance

Featured Experts:

Dr. Sinan B. Sarac, Senior Vice President, Head of Oncology Europe, Regulatory Consulting
Leveraging over a decade of European regulatory expertise, Dr. Sarac provides strategic insights to optimize your approach in the evolving JCA landscape.

Dr. Sangeeta Budhia, Senior Vice President, Pricing & Market Access 
With more than 20 years in evidence generation focusing on HTA and payer requirements, Dr. Budhia shares valuable insights from supporting biopharma companies in JCA implementation preparation.

Who should attend:

• Pharmaceutical and biotech leaders
• Regulatory affairs professionals
• Clinical development teams
• Market access strategist
• Health Technology Assessment specialists

At Parexel, we believe in empowering our partners with knowledge that drives innovation. Join us to stay ahead of the curve and transform your European market access strategy.