Critical New HTA Developments in Europe: Challenges & Solutions

With Prof. Dr Lieven Annemans

Course Details

Most countries have their own Health Technology Assessment (HTA) body with specific views about which criteria should be used and how the HTA process should be conducted.

On top of that, EU-level networks strive for a more efficient use of resources and increased collaboration between all stakeholders involved.

In this one-day course you will learn how companies should optimise processes and criteria in this complex environment.

By participating, you will not only have the chance to learn from a true health economics and HTA expert, but also experience the unique opportunity to share experiences and engage in in-depth discussions with your international peers.
 

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024

  1. The different types of HTAs in Europe.

  2. How to address the broad and evolving range of assessment criteria in Europe.

  3. How to optimise clinical evidence generation for HTA bodies.

  4. How to use Real-World Data for HTA purposes.

  5. How to prepare for the Joint Clinical Assessment (JCA) in the EU.

Course agenda

 

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

 

 

 

Welcome & Introductions (~15 min)
Definitions and Taxonomy of HTA (~1 h)
  • Definitions: what HTA is – and what it is not
  • Relationship and differences between HTA, health economic evaluations, and outcomes research
  • Different types of HTAs used for health technologies (such as medicines, medtech solutions, and others) and the wide variety across countries
Optimising the Mix of Criteria: Challenges & Solutions (~1 h 30 min)
  • The 10 possible criteria in the assessment of new health technologies and their relative weight
  • Challenging the QALY and going beyond the QALY
  • Evolution in the key criteria used by different HTA bodies
  • Dos and don’ts for addressing the different criteria
Generating Clinical Evidence: Challenges & Solutions (~45 min)
  • Evidence requirements by HTA bodies and payers: a moving target
  • The changing nature of clinical trials
  • How to optimise the evidence generation plan
  • How early dialogues and advice can increase HTA success rates
Lunch Break
The Increasing Need for Real World Data: Challenges & Solutions (~1 h 15 min)
  • Why Real-World Data is being used more and more for HTA purposes
  • Benefits of Real-World Data throughout the lifecycle of health technologies
  • Getting real on Real-World Data: dos and don’ts
Towards a Joint Clinical Assessment (JCA) in the EU: Challenges & Solutions (~1 h 30 min)
  • A brief history and a look forward
  • Pros & cons of JCA from different viewpoints (industry, payers, policy makers, patients, etc.)
  • Anticipating JCA: dos and don’ts 
Summary & Final Discussion (~15 min)

 

Download Brochure

 

Complete the below form to download the full course brochure. It outlines the detailed agenda, learning outcomes, expert info and some testimonials from past participants.

  • Prof. Dr Lieven Annemans has participated in more than 400 health economic evaluations in over 20 countries across a wide spectrum of therapeutic areas. He has also been involved as an expert in a large number of Health Technology Assessments (HTAs) and is actively involved in HTA on a European level.

  • Lieven has a unique profile: academic professor, past-president of ISPOR, author of Health economics for non-economists (Pelckmans Pro, 2018), trainer and consultant.

  • Highly respected for his vast international and cross-therapeutic experience, Lieven is a sought-after advisor and educator to health policy makers and the innovative healthcare industry.

  • Lieven has been on CELforPharma's faculty since 2009 and is always applauded by participants for his engaging and fun teaching style.
     

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

This course will be valuable to everyone for whom understanding the principles behind HTA, its usage and value is critical in their function, such as:

  • Market Access

  • Pricing & Reimbursement

  • Medical

  • Health Economics

  • Regulatory Affairs

  • Marketing

Would you like to receive a list of anonymised participant profiles from previous sessions? 

Email Annelies Swaan

 

 

UPCOMING DATES & FORMATS - FEES

11 December 2025

Live online (CET timing)

Early bird € 1 470

(until 07/11/2025)

(Full fee € 1 670)

 


TIMING & LOCATION

  • Live Online (CET): Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

  • Live Online (EST): Zoom sessions between 8 AM and 4 PM EST (Eastern Standard Time).

  • Face-to-Face: Held at the Crowne Plaza Brussels Airport (Da Vincilaan 4, 1831 Brussels), between 9 AM and 5 PM CET. Preferential hotel rates available for participants.

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan, Director Business Operations, for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses & self-study programme: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

The average Recommendation Score from participants of the last session was 

9,0/10!

 

 

Testimonials from past participants:

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024

The course and instructor were great. Lieven is clearly an expert in the field, with clear and articulate presentations. The interactions between attendees added to the experience, and I have gained valuable insights into the upcoming EU HTA changes. Highly recommended!

Novartis

Nick Riley, Senior Market Access Manager - Australia - June 2024

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

I got relevant information, it was refreshing also. The comparison of different countries' approaches and the excellent description of crucial parts of HTA were particularly useful. The experience from practice shared during the course enriched my understanding significantly.

Pharm-In

Dominik Grega, MA & HTA Manager - Slovakia - June 2024

People attending this course are typically also interested in: 

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis, Director of Client & Product Projects, will contact you with further information.
 

Course Details

Dates & Locations

11 December 2025

Live online (CET timing)

Register

Upcoming Session

11 December 2025, Live online (CET timing)

Early bird € 1 470

(until 07/11/2025)

 (Full fee € 1 670)

Prices are excl. VAT

Most countries have their own Health Technology Assessment (HTA) body with specific views about which criteria should be used and how the HTA process should be conducted.

On top of that, EU-level networks strive for a more efficient use of resources and increased collaboration between all stakeholders involved.

In this one-day course you will learn how companies should optimise processes and criteria in this complex environment.

By participating, you will not only have the chance to learn from a true health economics and HTA expert, but also experience the unique opportunity to share experiences and engage in in-depth discussions with your international peers.
 

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024

  1. The different types of HTAs in Europe.

  2. How to address the broad and evolving range of assessment criteria in Europe.

  3. How to optimise clinical evidence generation for HTA bodies.

  4. How to use Real-World Data for HTA purposes.

  5. How to prepare for the Joint Clinical Assessment (JCA) in the EU.

Course agenda

 

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

 

 

 

Welcome & Introductions (~15 min)
Definitions and Taxonomy of HTA (~1 h)
  • Definitions: what HTA is – and what it is not
  • Relationship and differences between HTA, health economic evaluations, and outcomes research
  • Different types of HTAs used for health technologies (such as medicines, medtech solutions, and others) and the wide variety across countries
Optimising the Mix of Criteria: Challenges & Solutions (~1 h 30 min)
  • The 10 possible criteria in the assessment of new health technologies and their relative weight
  • Challenging the QALY and going beyond the QALY
  • Evolution in the key criteria used by different HTA bodies
  • Dos and don’ts for addressing the different criteria
Generating Clinical Evidence: Challenges & Solutions (~45 min)
  • Evidence requirements by HTA bodies and payers: a moving target
  • The changing nature of clinical trials
  • How to optimise the evidence generation plan
  • How early dialogues and advice can increase HTA success rates
Lunch Break
The Increasing Need for Real World Data: Challenges & Solutions (~1 h 15 min)
  • Why Real-World Data is being used more and more for HTA purposes
  • Benefits of Real-World Data throughout the lifecycle of health technologies
  • Getting real on Real-World Data: dos and don’ts
Towards a Joint Clinical Assessment (JCA) in the EU: Challenges & Solutions (~1 h 30 min)
  • A brief history and a look forward
  • Pros & cons of JCA from different viewpoints (industry, payers, policy makers, patients, etc.)
  • Anticipating JCA: dos and don’ts 
Summary & Final Discussion (~15 min)

 

Download Brochure

 

Complete the below form to download the full course brochure. It outlines the detailed agenda, learning outcomes, expert info and some testimonials from past participants.

  • Prof. Dr Lieven Annemans has participated in more than 400 health economic evaluations in over 20 countries across a wide spectrum of therapeutic areas. He has also been involved as an expert in a large number of Health Technology Assessments (HTAs) and is actively involved in HTA on a European level.

  • Lieven has a unique profile: academic professor, past-president of ISPOR, author of Health economics for non-economists (Pelckmans Pro, 2018), trainer and consultant.

  • Highly respected for his vast international and cross-therapeutic experience, Lieven is a sought-after advisor and educator to health policy makers and the innovative healthcare industry.

  • Lieven has been on CELforPharma's faculty since 2009 and is always applauded by participants for his engaging and fun teaching style.
     

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

This course will be valuable to everyone for whom understanding the principles behind HTA, its usage and value is critical in their function, such as:

  • Market Access

  • Pricing & Reimbursement

  • Medical

  • Health Economics

  • Regulatory Affairs

  • Marketing

Would you like to receive a list of anonymised participant profiles from previous sessions? 

Email Annelies Swaan

 

 

UPCOMING DATES & FORMATS - FEES

11 December 2025

Live online (CET timing)

Early bird € 1 470

(until 07/11/2025)

(Full fee € 1 670)

 


TIMING & LOCATION

  • Live Online (CET): Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

  • Live Online (EST): Zoom sessions between 8 AM and 4 PM EST (Eastern Standard Time).

  • Face-to-Face: Held at the Crowne Plaza Brussels Airport (Da Vincilaan 4, 1831 Brussels), between 9 AM and 5 PM CET. Preferential hotel rates available for participants.

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan, Director Business Operations, for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses & self-study programme: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

The average Recommendation Score from participants of the last session was 

9,0/10!

 

 

Testimonials from past participants:

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024

The course and instructor were great. Lieven is clearly an expert in the field, with clear and articulate presentations. The interactions between attendees added to the experience, and I have gained valuable insights into the upcoming EU HTA changes. Highly recommended!

Novartis

Nick Riley, Senior Market Access Manager - Australia - June 2024

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

I got relevant information, it was refreshing also. The comparison of different countries' approaches and the excellent description of crucial parts of HTA were particularly useful. The experience from practice shared during the course enriched my understanding significantly.

Pharm-In

Dominik Grega, MA & HTA Manager - Slovakia - June 2024

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis, Director of Client & Product Projects, will contact you with further information.
 

Dates & Locations

11 December 2025

Live online (CET timing)

Register