Prof. Dr. Thomas Wilke

Generating RWE for Optimising Market/Patient Access

With Prof. Dr Thomas Wilke

Course Details

Real-World Evidence (RWE) has become an essential addition to Randomised Controlled Trials (RCTs) to further reduce regulatory, payer, physician, and patient uncertainty. 

Unfortunately, many companies struggle to implement it effectively. 

The key ingredient to success is a cross-functional organisation where managers have widespread knowledge of the fundamentals and use a shared vocabulary. 

In this course you will learn the fundamentals of RWE so that you can contribute effectively when decisions are made or when implementing RWE studies.

Not only will you have the opportunity to consult directly with a true RWE expert, but you’ll also engage in meaningful discussions and share experiences with international peers, making this a truly unique learning experience.
 

The training perfectly reflected the title and provided an excellent general overview of the RWD/RWE topic. I really valued the examples and the opportunity to ask questions. Thank you!

AOP Orphan Pharmaceuticals

Olga Shatilova, Clinical Development Manager - Austria - March 2025

  1. The expectations of external stakeholders regarding RWE throughout the product lifecycle.

  2. The fundamental concepts, methodologies, and research techniques of RWE in the context of optimising Market Access.

  3. Types of data and their strengths & weaknesses.

  4. Critical success factors of an RWE study.

  5. How to prepare for new developments in RWE generation. 

Course agenda

 

A very clear and understandable course that provided a comprehensive view of the usefulness and design of RWE studies. I now have a better understanding of what RWE studies are, particularly their value from both a regulatory and market access standpoint. I appreciated the focus on best practices for designing RWE studies.

Pierre Fabre

Laurent Fredon, International Market Access Manager - France - March 2025

 

 

 

Welcome & Introductions (~15 min)
Grasping the Full Spectrum of Stakeholder Needs and Uses of RWE (~1 h 30 min)
  • Defining RWD, RWE, and RWI (Real-World Insight)
  • Why HTA, regulatory, and payer decision-makers need RWE in addition to evidence from RCTs
  • Use cases of RWE and stakeholder needs throughout the entire product lifecycle, from discovery research to the mature phase
  • ‘It’s actually my data’ – The role of the patient
  • Learning from a case study
What You Need to Know About RWE Study Types and Data Sources (~1 h)
  • Overview of RWE study methodologies
  • Existing data sources:
    • Electronic medical records (EMR data)
    • Claims data
  • Bespoke data sources:
    • Patient registries
    • Pragmatic trials
    • Observational studies
    • Surveys
  • Geographical differences in access and content across data sources
Lunch Break
Group Discussion: Your Experiences and Challenges With RWE Data/Studies (~30 min)
The Outcomes That RWE Studies Can Generate: Challenges & Best Practices (~1 h 45 min)
  • Epidemiology: Incidence & prevalence
  • Treatment patterns
  • Adherence to and persistence with therapy
  • Health Care Resources Utilisation (HCRU) and cost
  • “Soft” clinical outcomes (e.g., disease progression)
  • “Hard” clinical outcomes (e.g., development of new morbidities)
  • Patient-reported outcomes (PROs)
Understanding the Design and Statistical Analyses in RWE Studies (~30 min)
  • Descriptive observational study methods
  • Comparative RWE studies
  • How to use AI to support statistical analyses
Guidelines For a Successful RWE Study & Group Exercise (~30 min)
  • What makes for a successful RWE study?
  • Example: NICE guidance for RWE
  • Interactive group exercise:
    • Considering a hypothetical example, evaluate how RWE studies could be used to support the reimbursement process.
    • Group output will be discussed in plenary and expert will close with his recommendations.
Wrap-Up & Closing (~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 Thomas Wilke has more than 25 years of experience in leading and conducting European and German RWE studies, including database studies, linked data studies, medical chart reviews, and surveys.

  • In addition to being an academic researcher and author of numerous articles, Thomas leads the university-affiliated institute IPAM and acts as a senior scientist at GIPAM, a consultancy specialising in European RWE studies.

  • Thomas has been on CELforPharma’s faculty since 2023 and participants consistently praise him for his engaging teaching style and his extensive knowledge and pragmatic approach to RWE.
     

The course is highly valuable for anyone discovering what RWE is. I appreciated the clear definitions, the breakdown of data types and generation, and the trainer’s expertise. Everything was explained very well, with plenty of examples. The group workshop was a great way to increase interaction!

Servier

Sophie Grand-Perret, Responsible Learning & Development - France - March 2025

As the RWE function is embedded in different departments and evolving at a different pace across the pharmaceutical industry, this course will benefit the many executive profiles who need the basics and need a common understanding in order to work effectively with their experienced colleagues in RWE:

  • Executives new to RWE
  • Recently appointed members to RWE teams
  • Pharma executives not currently working in RWE
  • Therapy area leads or brand leads
  • Market access leads
  • R&D and commercial teams requiring an understanding of RWE

If you are a consultant, please contact Annelies Swaan, who will check with the faculty whether you can attend. 

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

Email Annelies Swaan

 

 

UPCOMING DATES & FORMATS - FEES

9 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 

8,6/10!

 

 

Testimonials from past participants:

A very clear and understandable course that provided a comprehensive view of the usefulness and design of RWE studies. I now have a better understanding of what RWE studies are, particularly their value from both a regulatory and market access standpoint. I appreciated the focus on best practices for designing RWE studies.

Pierre Fabre

Laurent Fredon, International Market Access Manager - France - March 2025

The training perfectly reflected the title and provided an excellent general overview of the RWD/RWE topic. I really valued the examples and the opportunity to ask questions. Thank you!

AOP Orphan Pharmaceuticals

Olga Shatilova, Clinical Development Manager - Austria - March 2025

The course is highly valuable for anyone discovering what RWE is. I appreciated the clear definitions, the breakdown of data types and generation, and the trainer’s expertise. Everything was explained very well, with plenty of examples. The group workshop was a great way to increase interaction!

Servier

Sophie Grand-Perret, Responsible Learning & Development - France - March 2025

Nice training for those working in, or having touchpoints with, RWE generation. As always, comprehensive and well-structured.

Femke Baeke, Medical Advisor - Belgium - March 2025

A colleague recommended CELforPharma, and he was right! Top quality course with an excellent speaker, thank you!

Viatris

Kareem Radwan, Head of Market Access, Channels & Reimbursement METL - United Arab Emirates - November 2024

The course met all the expectations I had, with a lot of opportunities to ask questions throughout. The wide range of topics covered in depth and the group exercise at the end were valuable for putting what we learned into practice. Dr Wilke was very engaging, and it was clear that he knows the subject really well.

Jazz Pharmaceuticals

Jamshaed Siddiqui, Senior Manager, HEOR, Europe & International - United Kingdom - June 2024

If you are looking for a training on the topic of generating RWE for Optimising Market/Patient Access, this is the perfect one for you! Every topic was delivered comprehensively and was covered from every angle with plenty of room for Q&A. The hands-on workshop was highly useful to put the theory of what we were learning into practice. The expert did a great job at presenting the course and also facilitating lots of interesting interaction throughout the day.

Bayer

Simone Caruso, Strategic Market Access Intelligence - Germany - June 2023

I definitely made the right choice by attending this training. I have learned so much and also have a good source of information I can look back on when needed in the future. It was very well organised by CELforPharma and excellently presented by the knowledgeable and professional presenter. Thank you all, it was truly an enjoyable and highly valuable day.

Galderma

Torun Bromée, Global Medical Franchise Lead - Sweden - June 2023

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.
 

We received very positive feedback from the team about Thomas (the expert) and the in-company session! Terrific, we all loved it and found it useful.
 

Merz Therapeutics

Selena Freisens, MD, Head of Global Medical Affairs - Germany - Generating RWE for Optimising Market/Patient Access

Course Details

Dates & Locations

9 December 2025

Live online (CET timing)

Register

Upcoming Session

9 December 2025, Live online (CET timing)

Early bird € 1 470

(until 07/11/2025)

 (Full fee € 1 670)

Prices are excl. VAT

Real-World Evidence (RWE) has become an essential addition to Randomised Controlled Trials (RCTs) to further reduce regulatory, payer, physician, and patient uncertainty. 

Unfortunately, many companies struggle to implement it effectively. 

The key ingredient to success is a cross-functional organisation where managers have widespread knowledge of the fundamentals and use a shared vocabulary. 

In this course you will learn the fundamentals of RWE so that you can contribute effectively when decisions are made or when implementing RWE studies.

Not only will you have the opportunity to consult directly with a true RWE expert, but you’ll also engage in meaningful discussions and share experiences with international peers, making this a truly unique learning experience.
 

The training perfectly reflected the title and provided an excellent general overview of the RWD/RWE topic. I really valued the examples and the opportunity to ask questions. Thank you!

AOP Orphan Pharmaceuticals

Olga Shatilova, Clinical Development Manager - Austria - March 2025

  1. The expectations of external stakeholders regarding RWE throughout the product lifecycle.

  2. The fundamental concepts, methodologies, and research techniques of RWE in the context of optimising Market Access.

  3. Types of data and their strengths & weaknesses.

  4. Critical success factors of an RWE study.

  5. How to prepare for new developments in RWE generation. 

Course agenda

 

A very clear and understandable course that provided a comprehensive view of the usefulness and design of RWE studies. I now have a better understanding of what RWE studies are, particularly their value from both a regulatory and market access standpoint. I appreciated the focus on best practices for designing RWE studies.

Pierre Fabre

Laurent Fredon, International Market Access Manager - France - March 2025

 

 

 

Welcome & Introductions (~15 min)
Grasping the Full Spectrum of Stakeholder Needs and Uses of RWE (~1 h 30 min)
  • Defining RWD, RWE, and RWI (Real-World Insight)
  • Why HTA, regulatory, and payer decision-makers need RWE in addition to evidence from RCTs
  • Use cases of RWE and stakeholder needs throughout the entire product lifecycle, from discovery research to the mature phase
  • ‘It’s actually my data’ – The role of the patient
  • Learning from a case study
What You Need to Know About RWE Study Types and Data Sources (~1 h)
  • Overview of RWE study methodologies
  • Existing data sources:
    • Electronic medical records (EMR data)
    • Claims data
  • Bespoke data sources:
    • Patient registries
    • Pragmatic trials
    • Observational studies
    • Surveys
  • Geographical differences in access and content across data sources
Lunch Break
Group Discussion: Your Experiences and Challenges With RWE Data/Studies (~30 min)
The Outcomes That RWE Studies Can Generate: Challenges & Best Practices (~1 h 45 min)
  • Epidemiology: Incidence & prevalence
  • Treatment patterns
  • Adherence to and persistence with therapy
  • Health Care Resources Utilisation (HCRU) and cost
  • “Soft” clinical outcomes (e.g., disease progression)
  • “Hard” clinical outcomes (e.g., development of new morbidities)
  • Patient-reported outcomes (PROs)
Understanding the Design and Statistical Analyses in RWE Studies (~30 min)
  • Descriptive observational study methods
  • Comparative RWE studies
  • How to use AI to support statistical analyses
Guidelines For a Successful RWE Study & Group Exercise (~30 min)
  • What makes for a successful RWE study?
  • Example: NICE guidance for RWE
  • Interactive group exercise:
    • Considering a hypothetical example, evaluate how RWE studies could be used to support the reimbursement process.
    • Group output will be discussed in plenary and expert will close with his recommendations.
Wrap-Up & Closing (~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 Thomas Wilke has more than 25 years of experience in leading and conducting European and German RWE studies, including database studies, linked data studies, medical chart reviews, and surveys.

  • In addition to being an academic researcher and author of numerous articles, Thomas leads the university-affiliated institute IPAM and acts as a senior scientist at GIPAM, a consultancy specialising in European RWE studies.

  • Thomas has been on CELforPharma’s faculty since 2023 and participants consistently praise him for his engaging teaching style and his extensive knowledge and pragmatic approach to RWE.
     

The course is highly valuable for anyone discovering what RWE is. I appreciated the clear definitions, the breakdown of data types and generation, and the trainer’s expertise. Everything was explained very well, with plenty of examples. The group workshop was a great way to increase interaction!

Servier

Sophie Grand-Perret, Responsible Learning & Development - France - March 2025

As the RWE function is embedded in different departments and evolving at a different pace across the pharmaceutical industry, this course will benefit the many executive profiles who need the basics and need a common understanding in order to work effectively with their experienced colleagues in RWE:

  • Executives new to RWE
  • Recently appointed members to RWE teams
  • Pharma executives not currently working in RWE
  • Therapy area leads or brand leads
  • Market access leads
  • R&D and commercial teams requiring an understanding of RWE

If you are a consultant, please contact Annelies Swaan, who will check with the faculty whether you can attend. 

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

Email Annelies Swaan

 

 

UPCOMING DATES & FORMATS - FEES

9 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 

8,6/10!

 

 

Testimonials from past participants:

A very clear and understandable course that provided a comprehensive view of the usefulness and design of RWE studies. I now have a better understanding of what RWE studies are, particularly their value from both a regulatory and market access standpoint. I appreciated the focus on best practices for designing RWE studies.

Pierre Fabre

Laurent Fredon, International Market Access Manager - France - March 2025

The training perfectly reflected the title and provided an excellent general overview of the RWD/RWE topic. I really valued the examples and the opportunity to ask questions. Thank you!

AOP Orphan Pharmaceuticals

Olga Shatilova, Clinical Development Manager - Austria - March 2025

The course is highly valuable for anyone discovering what RWE is. I appreciated the clear definitions, the breakdown of data types and generation, and the trainer’s expertise. Everything was explained very well, with plenty of examples. The group workshop was a great way to increase interaction!

Servier

Sophie Grand-Perret, Responsible Learning & Development - France - March 2025

Nice training for those working in, or having touchpoints with, RWE generation. As always, comprehensive and well-structured.

Femke Baeke, Medical Advisor - Belgium - March 2025

A colleague recommended CELforPharma, and he was right! Top quality course with an excellent speaker, thank you!

Viatris

Kareem Radwan, Head of Market Access, Channels & Reimbursement METL - United Arab Emirates - November 2024

The course met all the expectations I had, with a lot of opportunities to ask questions throughout. The wide range of topics covered in depth and the group exercise at the end were valuable for putting what we learned into practice. Dr Wilke was very engaging, and it was clear that he knows the subject really well.

Jazz Pharmaceuticals

Jamshaed Siddiqui, Senior Manager, HEOR, Europe & International - United Kingdom - June 2024

If you are looking for a training on the topic of generating RWE for Optimising Market/Patient Access, this is the perfect one for you! Every topic was delivered comprehensively and was covered from every angle with plenty of room for Q&A. The hands-on workshop was highly useful to put the theory of what we were learning into practice. The expert did a great job at presenting the course and also facilitating lots of interesting interaction throughout the day.

Bayer

Simone Caruso, Strategic Market Access Intelligence - Germany - June 2023

I definitely made the right choice by attending this training. I have learned so much and also have a good source of information I can look back on when needed in the future. It was very well organised by CELforPharma and excellently presented by the knowledgeable and professional presenter. Thank you all, it was truly an enjoyable and highly valuable day.

Galderma

Torun Bromée, Global Medical Franchise Lead - Sweden - June 2023

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.
 

We received very positive feedback from the team about Thomas (the expert) and the in-company session! Terrific, we all loved it and found it useful.
 

Merz Therapeutics

Selena Freisens, MD, Head of Global Medical Affairs - Germany - Generating RWE for Optimising Market/Patient Access

Dates & Locations

9 December 2025

Live online (CET timing)

Register