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The European Health Technology Assessment (HTA) process – get on the learning curve
Stay updated on the evolving EU landscape of health technology assessment
This course is a part of
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?
What is the European HTA process?
The European HTA process has developed over more than10 years through voluntary cooperation of HTA agencies during the EUnetHTA joint action programs.
The HTA Regulation creates a permanent framework for collaboration across all 27 member states to reduce duplication, align evidence requirements, and accelerate patient access. A key pillar is the EU-level Joint Clinical Assessment (JCA), supporting national appraisals.
The process took effect on 12th January 2025 for oncology products and cell & gene therapies, expanding to orphan drugs in 2028 and all health technologies by 2030. HT developers can also request joint scientific consultations (JSC) for pipeline assets.
For more details about the course, please refer to the course curriculum.
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Course directors and lecturers on »The European Health Technology Assessment (HTA) process – get on the learning curve«
Marlene Gyldmark
EU HTA lead, BeiGene
Inka Heikkinen
Regulatory Policy Lead, Director at Lundbeck
Claudine Sapède
Director, Global HTA Policy, Novartis
Course details for »The European Health Technology Assessment (HTA) process – get on the learning curve«
Dates and examination
Learning outcomes
On completion of the course, you will be able to:
- understand the basic elements, terminology, and key stakeholders of HTA
- describe the EU HTA process, key deliverables, milestones, and decision-makers
- identify the opportunities, challenges, and national implications of the EU HTA system
- explain the JCA and JSC processes, their deliverables, and role in decision-making
- recognize how JSC connects to national advice and the role of stakeholders like patients and clinicians.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent.
- Have a minimum 2 years of relevant job experience in drug development.
- Be proficient in English.
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as an elective course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens
16,650 DKK
Non-EU/EEA citizens
18,425 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Place
University of Copenhagen
Department of Pharmacy /
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel: +45 35 33 60 66
Marlene Gyldmark
EU HTA lead, BeiGene
In my current role I lead the EU HTA organisational preparedness at BeiGene in the Global Value, Market Access, and Pricing group.
I began my professional career in Tanzania, at the Ministry of Health in Dar Es Salaam, employed by the Danish International Development Agency. After this I was employed as researcher at the University of Copenhagen, after which I moved into health service research, employed at the Danish Hospital Institute where I worked on a variety of research projects related to health economics, as well as financing and the regulation of medicine use in Denmark. After several years at the Danish Hospital Institute I moved to the pharmaceutical industry, first at Novo Nordisk headquarters in Denmark, then Pfizer Denmark, Roche headquarters in Basel, Switzerland, Idorsia, Basel, Switzerland, and Viatris Innovation, Basel, Switzerland.
During most of my professional career I have been involved in teaching and training. First as external lecturer at Copenhagen University, and later as external lecturer and course coordinator for executive training in Market Access, Digital Health, and Value Based Health Care at Copenhagen Summer University. Other experiences includes being a member of the board (2000-2012) at EASE Consulting, and member of the board of the Institute of Neurodiversity (2021- 2025). Marlene has been a long-term member of ISPOR and served on the board of directors between 2021- 2024. Marlene also serves as Copenhagen Goodwill Ambassador.
Marlene holds a Master in Economics and Policy Sciences from University of Copenhagen, Denmark, and a MPhil in Health Economics from York University, UK
Inka Heikkinen
Regulatory Policy Lead, Director at Lundbeck
Inka has been involved very closely in HTA Regulation implementation at EFPIA since the very beginning. She leads EFPIA workstream around regulatory-HTA interaction and Joint Scientific Consultation, with extensive work on defining industry positions and thinking around the future processes and system on Marketing Authorisation review process and Joint Clinical Assessment.
As her day job, she leads R&D and regulatory policy strategy and operational excellence at Lundbeck, working with senior leaders defining and advocating for policies that optimizes the environment for future health technologies. Inka holds master degrees on health economics and in policy, an Executive MBA degree with specialisation in finance.
Claudine Sapède
Director, Global HTA Policy, Novartis
Claudine Sapède is Director, Global HTA Policy at Novartis in Global Public Affairs based in Basel, Switzerland. In this role, she focuses on value assessment, HTA and reimbursement decision-making approaches and policies as well as their impact on patient access to innovative treatments. She engages with internal and external stakeholders involved in setting or shaping HTA, pricing and reimbursement decisions.
Claudine is currently an active member of the EFPIA’s market access and HTA working groups and lead one of the workstream related to the implementation of the EU HTA regulation.
Prior to this role, she has had a range of different roles both at country and global levels. Her business career in the pharmaceutical sector over 20 years spans the full spectrum of evidence generation, value demonstration, market access strategies, pricing, and policy.