The European Health Technology Assessment (HTA) process – get on the learning curve
Course content
What is the European HTA process?
The European HTA process has developed over the last >10 years through voluntary cooperation of HTA agencies during the EUnetHTA joint action programs. The HTA Regulation creates a permanent framework of collaboration involving all 27 member states. The objective is to avoid duplication of work, align evidence requirements for health technologies across the European Member states and ultimately accelerate access for patients. The key pillars for the joint work involve a EU level Joint Clinical Assessment (JCA) of the technology that will support appraisal at member state level. The process came into effect on 12th January 20025 for new oncology products and cell & gene therapies and will be expanded to orphan drugs in 2028 and in 2030 the process will cover all health technologies. In addition, there will be the opportunity for HT developers to ask for joint scientific consultations (JSC) for pipeline assets.
This course will provide insight into the terminology, key principles and key players in the field of the European HTA process. It will provide a practical understanding of the guidelines and the “rules of the road” from JSC to JCA.
The following themes will be addressed:
- What is HTA?
- What is the European HTA process?
- Who are the key stakeholders?
- What is covered under the EU HTA process?
- How to prepare for a successful EU HTA/JCA dossier
- What is JSC and how to prepare for it?
- How are national HTA bodies expected to incorporate the JCA?
Master of Industrial Drug Development (MIND) - elective
The course is preapproved as an elective in the
Master Medicines Regulatory Affairs
(MRA) programme.
Upon completion of the course, students are expected to be able to:
Knowledge
- Understand key concepts, terminology, and the overall structure of Health Technology Assessment (HTA).
- Gain insight into the EU HTA process, including key deliverables, milestones, and decision-makers.
- Comprehend the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) processes and their impact.
- Recognize how EU HTA interacts with national HTA, pricing, and reimbursement systems.
Skills
- Analyze and interpret EU HTA procedures and outcomes.
- Apply JCA and JSC insights to national and organizational contexts.
- Engage effectively with key stakeholders in the EU HTA landscape.
- Navigate the link between EU and national HTA processes to support decision-making.
Competences
- Strategically apply HTA knowledge to healthcare innovation and market access.
- Influence evidence-based decision-making in regulatory and reimbursement frameworks.
- Collaborate with policymakers, clinicians, and industry experts in HTA processes.
- Drive impactful contributions to EU and national HTA discussions.
Teaching methods consist of a combination of lectures, group discussions, case studies, presentations, exercises and panel discussions.
The compulsory syllabus comprises a collection of scientific articles, review papers and case studies corresponding to approximately 500 pages (extra 200 pages self-selected literature for the optional exam).
Registered students register via the self-service on
KUnet.
New students apply
via this link:
The European Health Technology Assessment (HTA) process – get on
the learning curve – University of Copenhagen
- ECTS
- 2,5 ECTS
- Type of assessment
-
Home assignment
- Type of assessment details
- A written set assignment. Individual assignment based on a relevant set of questions provided by the course managers and based on an extended literature list.
- Aid
- All aids allowed
Read more about the GAI-rules: Generative AI and good academic practice in UCPH's education programmes – University of Copenhagen
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
-
See exam schedule.
- Re-exam
-
Same as the ordinary exam.
Criteria for exam assessment
To achieve the grade of a pass, the participant shall (in an adequate level) be able to demonstrate:
Knowledge
- Understand key concepts, terminology, and the overall structure of Health Technology Assessment (HTA).
- Gain insight into the EU HTA process, including key deliverables, milestones, and decision-makers.
- Comprehend the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) processes and their impact.
- Recognize how EU HTA interacts with national HTA, pricing, and reimbursement systems.
Skills
- Analyze and interpret EU HTA procedures and outcomes.
- Apply JCA and JSC insights to national and organizational contexts.
- Engage effectively with key stakeholders in the EU HTA landscape.
- Navigate the link between EU and national HTA processes to support decision-making.
Competences
- Strategically apply HTA knowledge to healthcare innovation and market access.
- Influence evidence-based decision-making in regulatory and reimbursement frameworks.
- Collaborate with policymakers, clinicians, and industry experts in HTA processes.
- Drive impactful contributions to EU and national HTA discussions.
Part time Master courses
- Category
- Hours
- Class Instruction
- 18
- Preparation
- 35
- Exam
- 15
- English
- 68
Kursusinformation
- Language
- English
- Course number
- SMIM25002U
- ECTS
- 2,5 ECTS
- Programme level
- Part Time Master
Full Degree Master choice
- Duration
-
See course webpage for specific dates.
- Placement
- Summer
- Price
-
See course fee details at course webpage.
- Schedulegroup
-
August
- Capacity
- 25 participants
- Studyboard
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Marlene Gyldmark (16-7064756f687168316a7c6f677064756e4376787167316e7831676e)
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