The first comprehensive live course to prepare you for JCA and JSC.
EU HTA Training
New EU HTA processes in place
How to navigate in complex landscape?
Starting in 2025, Health Technology Developers (HTDs) introducing innovative cancer treatments and advanced therapy medicinal products at the European level must comply with the new EU HTA regulation. This includes:
• Joint Clinical Assessment (JCA) – a mandatory process that evaluates the clinical evidence of new treatments across EU Member States
• Joint Scientific Consultation (JSC) – an optional but strategic step for optimizing evidence generation.
The regulation was originally designed to streamline decision-making, reduce duplication of efforts, and enhance collaboration among Member States. In practice, it centralizes the management of multiple independent submissions (PICOs) aggregated into a single dossier, increasing complexity and risk for HTD.
Requirements
and challenges for HTDs
H
The implementation of EU HTA will entail several requirements for HTDs:
- Anticipating and considering scoping of multiple PICOs;
- Increased within-company competition (regulatory, clinical, market access) to influence study design strategies;
- The need to initiate dossier preparation early due to short timelines for submission;
- Balancing EU-level and national-level evidence generation and submission.
The implementation also presents multiple challenges for HTDs, including, but not limited to:
- Lack of inclusiveness and transparency in processes;
- Low-quality guidance documents developed outside of state-of-the-art practices;
- Lack of applicant guidance;
- Implementation complexity;
- Insufficient resources and expertise to ensure high-quality impartial assessment.
What will change
after this course ?
Our comprehensive live course is designed to prepare you for these critical requirements and help you secure a smooth market access journey.
What will you get?
Foundations of the EU HTA Regulation
Understand the foundations of the EU HTA Regulation with sessions covering its evolution from EUnetHTA, an informative and a critical review of its implementation acts, and a Single Arm Trials case study. The day concludes with an engaging panel discussion.
Navigating JCA Procedures, Stakeholder Roles & Real-World Applications
Dive into the procedural details of Joint Clinical Assessments (JCAs), Member States’ responsibilities, and stakeholder communication strategies. Explore member profiles of various groups, analyze an Orphan Drug case study, and participate in another thought-provoking panel discussion.
Deep Dive into Advanced HTA Methodologies & JCA Development
Examine advanced topics like ITC guidance for indirect evidence development, rapid systematic literature reviews (SLRs), and PICO framework applications in JCA. Analyze templates for JCA development, discuss an ATMP case study, and participate in a lively panel session.
JCA Impact, Joint Scientific Consultation & Future of EU HTA
Assess the impact of JCA reports on Member State HTA recommendations and explore Joint Scientific Consultation (JSC). Delve into why the EU HTA may succeed or fail, participate in the EUREKA session, and wrap up with key takeaways during the conclusion and discussion.
Our contributors
Mira Pavlovic
Scientific Advisor Clinical, Regulatory & HTA
Mondher Toumi
CEO at InovIntell, President of MAS
Jörg Ruof
Founder at r-connect.org
Dávid Dankó
Managing partner at Ideas & Solutions
Frank Ulrich Fricke
Professor of Health Economics at the Nuremberg Institute of Technology
Steven Simoens
Professor of health economics at KU Leuven
Frequently Asked About...
Profile of candidates?
- Market Access Specialist
- Pharmaceutical Industry Specialist
- Health Economists
- Healthcare Professionals
- Policy Makers and Regulatory Affairs Specialists
- Researchers and academics interested in health technology assessment and policy.
Practical or theoretical?
The EU HTA training program will provide a thorough and balanced curriculum, incorporating both theoretical and practical aspects. The theoretical portion will cover the principles, structure, and objectives of the EU HTA Regulation, ensuring that participants comprehend its implications and key components. On the practical side, the training will aim to develop skills for effectively interpreting the regulation and guidance, enabling participants to apply them in a tailored manner. This approach will empower participants to confidently navigate EU HTA regulation and guidance documents, equipping them with the knowledge and abilities necessary to engage proficiently in the JSC and JCA processes.
Does the course give me any diploma?
Participants in the EU Health Technology Assessment (HTA) training programs will receive certificates issued by the Market Access Society upon successful completion. These certificates will be personalized and provided in an electronic format, signed by Professor Mondher Toumi.
What is the exact date of the course?
Next session will be 19th, 20th, 26th i 27 th May
How can I apply?
Sign up for waiting list!
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Looking for knowledge?
Join us to demystify the JCA and JSC processes and ensure your organization is fully equipped to navigate the evolving EU HTA landscape.