Dr. Marco Ghiani
Prof. Dr. Thomas Wilke

Generating RWE for Optimising Market/Patient Access

By Dr. Marco Ghiani & Prof. Dr. Thomas Wilke

Course Details

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 implementing it. 

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

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

By participating, you will not only have the chance to ask your specific questions to true RWE experts, but also experience the unique opportunity to share experiences and engage in in-depth discussions with your international peers. 

  1. The expectations of external stakeholders regarding RWE along 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 a RWE study.

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

The Use of RWE along Product Lifecycle

 

 

To see the detailed agenda, please submit your details in the form below the table.

From RCT to RWD and RWE – A Continuum of Evidence (~1 h)
The Role of RWE and Stakeholder Perspectives Throughout the Drug Development Lifecycle (~1 h)
Typology of RWD Sources: Strengths & Weaknesses (~45 min)
Lunch Break
Critical Success Factors of a RWE Study (~1 h)
Interactive Group Exercise: How to Build an Effective RWE Generation Plan (~1 h 30 min)
The Next Frontiers: ‘Live RWE’ (~30 min)
Wrap-Up & Closing (~15 min)

 

To see the detailed agenda, please submit your details in the form below:

  • Marco is Head of Real-World Evidence, Germany, at Cytel, a leading provider of design and implementation services in the field of clinical trials and real-world evidence studies. He has extensive experience working and leading health database analyses and RWE studies, with expertise in designing and conducting analyses of large European databases, including claims data, electronic medical records, and data from medical chart reviews.

  • Thomas has 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 is leading the University-affiliated institute IPAM and acts as senior scientist at GIPAM, a consultancy specialised on European RWE studies.

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 inge.cornelis@celforpharma.com

Read this selection of testimonials from recent participants: 

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 experts 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 presenters. Thank you all, it was truly an enjoyable and highly valuable day.

Galderma

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

29 November 2023, Live online

Early bird € 1 470

(Full fee € 1 670)

(until 27/10/2023)

Important information:

  • Our courses typically take place between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris).
  • Live online sessions will be hosted in Zoom.
  • Face-to-face courses will take place at a four-star business hotel close to the airport.
  • You will receive all practical details after your registration.

For any questions related to the above, please do not hesitate to email Kealeigh Steel or contact her by phone at +32 2 709 01 45.

How to Register

  1. Click the green "Register" button on the course session of your preference.

  2. The registration wizard will guide you through the personal and company data that we need to process your registration.

  3. You have the choice between 2 payment options:

    1. Payment by credit card. You will not be required to pay immediately, but you will receive a secured payment link together with the invoice.

    2. Payment via bank transfer

  4. Click "Register Now". You will be sent an automatic email confirming your registration followed by a personal email containing an invoice and further payment instructions.


For assistance with your registration, please email Kealeigh Steel or contact her by phone at +32 2 709 01 45.
 

Included in the Registration Fee:

For live online courses:

  • Access to a virtual small-class (max 20 participants), expert led course in real-time, using an interactive platform for break-out rooms, whiteboard exercises, polling, plenary discussions and chats.

  • Course material will be provided to you in both digital format (by email) and in hard copy (by post, so you can make notes during the course).

  • Certificate of attendance signed by the experts and CELforPharma.
     

VAT Information

The prices on our website are excluding VAT. Depending on the format of the course (face-to-face in Brussels or live online or self-study programme) and your location, we are obliged by Belgian law to apply VAT.

We are obliged by Belgian law to apply VAT in the following cases:

Face-to-Face public course organised in Belgium


Article 53 of the European Union VAT Directive 2006/112 states that : “The place of supply of services in respect of admission to cultural, artistic, sporting, scientific, educational, entertainment or similar events, such as fairs and exhibitions, and of ancillary services related to the admission, supplied to a taxable person, shall be the place where those events actually take place.” 
If the course that you register for takes place in Belgium, we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Online Public courses -  live webinar


Webinars where the participants can communicate among themselves or ask questions to the speaker(s) (be it verbally, via a chat function or similar), are considered as ‘online interactive webinars’ by the Belgian VAT administration. 
According to Article 53 of the European Union VAT Directive 2006/112, these online interactive webinars take place where the organisation of the seminar takes place, which in this case is Belgium. 
So, if you register for one of our live online courses (organised from our offices in Belgium), we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Self-Study Programme:


A self-study programme is a service provided electronically. It is the period of self-study that is the most important in our self-study Basics of Health Economics and not the kickoff and closing webinars. As a result, this self-study program follows a different VAT application and the place of the service is where the customer is established. Therefore, we follow the VAT rules applicable to the country of your invoicing address.

 

Group Discounts

Team discounts can be offered to 3 or more delegates from the same company.

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

Transfer & Cancellation Policy

Flexible Transfer

  • If a registrant cannot attend the scheduled course, he/she can avoid any cancellation charge by sending a suitable replacement participant.

  • Alternatively, the registrant can transfer once on a “space available” basis at no extra cost, until 3 weeks prior to the event, to another course of the same value held within one year of the original course date.

Registration Cancellation

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

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

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

  • If a registrant postpones his/her participation to a future course, and cancels again, no refund can be claimed for registration fees.

 

Benefits of CELforPharma’s face-to-face courses:

  • You have the unique opportunity to interact 1:1 with the expert(s).

  • Plenty of opportunity for informal 1:1 and group conversations with your international peers to exchange experiences and ideas, to discuss issues and to network.

  • Face-to-face interactions allow for more depth during Q&As and group work.

  • You can step away from your daily routine in the office and enjoy a more focused learning experience in a comfortable business hotel environment.

 

Benefits of CELforPharma’s live online courses:

  • The formal programme is as impactful as a face-to-face course thanks to the highly interactive format (using breakouts, polls, quizzes …).

  • No travel & accommodation expenses

  • You can attend the course from the comfort of your own office or home.

  • We send you the course materials by post so that you can take notes and fully engage with the course content.

No, if you choose credit card payment, we will send you a secure payment link together with the invoice.

Team discounts can be offered for 3 or more registrations confirmed at the same time. The level of discount will depend on the number of registrations and the availability of seats.

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

Depending on the format of the course (face-to-face in Brussels or live online or self-study programme) and your location, we are obliged by Belgian law to apply VAT in the following cases:

Face-to-Face public course organised in Belgium


Article 53 of the European Union VAT Directive 2006/112 states that : “The place of supply of services in respect of admission to cultural, artistic, sporting, scientific, educational, entertainment or similar events, such as fairs and exhibitions, and of ancillary services related to the admission, supplied to a taxable person, shall be the place where those events actually take place.” 
If the course that you register for takes place in Belgium, we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Online Public courses -  live webinar


Webinars where the participants can communicate among themselves or ask questions to the speaker(s) (be it verbally, via a chat function or similar), are considered as ‘online interactive webinars’ by the Belgian VAT administration. 
According to Article 53 of the European Union VAT Directive 2006/112, these online interactive webinars take place where the organisation of the seminar takes place, which in this case is Belgium. 
So, if you register for one of our live online courses (organised from our offices in Belgium), we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Self-Study Programme:


A self-study programme is a service provided electronically. It is the period of self-study that is the most important in our self-study Basics of Health Economics and not the kickoff and closing webinars. As a result, this self-study program follows a different VAT application and the place of the service is where the customer is established. Therefore, we follow the VAT rules applicable to the country of your invoicing address.

Our face-to-face courses in Brussels and Zurich take place in four-star business hotels close to the airport. As part of our strong relationship with these hotels, CELforPharma has secured a discount on the daily room rate for our delegates who book their accommodation via us. 

Upon your registration, we will assist you to make your hotel booking. For any assistance in this matter please do not hesitate to email Kealeigh Steel, Senior Programme Coordinator, or contact her by phone at +32 2 709 01 45. 

We do not record our live online public courses as we want to offer a safe environment for all attendees to share their experiences and freely ask questions.

This way, by participating in our courses, you do not only learn from our expert faculty but also from your international peers in the room.

No, we don't sell the course materials as a stand-alone. 
Without the expert's explanation, the exercises and the discussions with other course participants, there is very little value in the slides.

Email Inge Cornelis, partner with CELforPharma, to help you choose the course that is best suited. 

Yes! 

We have helped many managers with setting up an in-house training programme for their team. 

Email Inge Cornelis, partner with CELforPharma, to discuss your team training needs.

Do you have any other questions? 
Email Annelies Swaan or call +32 2 709 01 42.

By clicking the below button, you will save this course to MY COURSES in the upper right corner of the website. This allows you to quickly retrieve it later. 

Don’t forget to make a personal account using the Login button in the upper right corner of the website to keep your list of saved courses for your next visit.

Dates & Locations

29 November 2023

Live online

Register

Upcoming Session

29 November 2023, Live online

Early bird € 1 470

(Full fee € 1 670)

(until 27/10/2023)

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 implementing it. 

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

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

By participating, you will not only have the chance to ask your specific questions to true RWE experts, but also experience the unique opportunity to share experiences and engage in in-depth discussions with your international peers. 

  1. The expectations of external stakeholders regarding RWE along 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 a RWE study.

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

The Use of RWE along Product Lifecycle

 

 

To see the detailed agenda, please submit your details in the form below the table.

From RCT to RWD and RWE – A Continuum of Evidence (~1 h)
The Role of RWE and Stakeholder Perspectives Throughout the Drug Development Lifecycle (~1 h)
Typology of RWD Sources: Strengths & Weaknesses (~45 min)
Lunch Break
Critical Success Factors of a RWE Study (~1 h)
Interactive Group Exercise: How to Build an Effective RWE Generation Plan (~1 h 30 min)
The Next Frontiers: ‘Live RWE’ (~30 min)
Wrap-Up & Closing (~15 min)

 

To see the detailed agenda, please submit your details in the form below:

  • Marco is Head of Real-World Evidence, Germany, at Cytel, a leading provider of design and implementation services in the field of clinical trials and real-world evidence studies. He has extensive experience working and leading health database analyses and RWE studies, with expertise in designing and conducting analyses of large European databases, including claims data, electronic medical records, and data from medical chart reviews.

  • Thomas has 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 is leading the University-affiliated institute IPAM and acts as senior scientist at GIPAM, a consultancy specialised on European RWE studies.

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 inge.cornelis@celforpharma.com

Read this selection of testimonials from recent participants: 

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 experts 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 presenters. Thank you all, it was truly an enjoyable and highly valuable day.

Galderma

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

29 November 2023, Live online

Early bird € 1 470

(Full fee € 1 670)

(until 27/10/2023)

Important information:

  • Our courses typically take place between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris).
  • Live online sessions will be hosted in Zoom.
  • Face-to-face courses will take place at a four-star business hotel close to the airport.
  • You will receive all practical details after your registration.

For any questions related to the above, please do not hesitate to email Kealeigh Steel or contact her by phone at +32 2 709 01 45.

How to Register

  1. Click the green "Register" button on the course session of your preference.

  2. The registration wizard will guide you through the personal and company data that we need to process your registration.

  3. You have the choice between 2 payment options:

    1. Payment by credit card. You will not be required to pay immediately, but you will receive a secured payment link together with the invoice.

    2. Payment via bank transfer

  4. Click "Register Now". You will be sent an automatic email confirming your registration followed by a personal email containing an invoice and further payment instructions.


For assistance with your registration, please email Kealeigh Steel or contact her by phone at +32 2 709 01 45.
 

Included in the Registration Fee:

For live online courses:

  • Access to a virtual small-class (max 20 participants), expert led course in real-time, using an interactive platform for break-out rooms, whiteboard exercises, polling, plenary discussions and chats.

  • Course material will be provided to you in both digital format (by email) and in hard copy (by post, so you can make notes during the course).

  • Certificate of attendance signed by the experts and CELforPharma.
     

VAT Information

The prices on our website are excluding VAT. Depending on the format of the course (face-to-face in Brussels or live online or self-study programme) and your location, we are obliged by Belgian law to apply VAT.

We are obliged by Belgian law to apply VAT in the following cases:

Face-to-Face public course organised in Belgium


Article 53 of the European Union VAT Directive 2006/112 states that : “The place of supply of services in respect of admission to cultural, artistic, sporting, scientific, educational, entertainment or similar events, such as fairs and exhibitions, and of ancillary services related to the admission, supplied to a taxable person, shall be the place where those events actually take place.” 
If the course that you register for takes place in Belgium, we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Online Public courses -  live webinar


Webinars where the participants can communicate among themselves or ask questions to the speaker(s) (be it verbally, via a chat function or similar), are considered as ‘online interactive webinars’ by the Belgian VAT administration. 
According to Article 53 of the European Union VAT Directive 2006/112, these online interactive webinars take place where the organisation of the seminar takes place, which in this case is Belgium. 
So, if you register for one of our live online courses (organised from our offices in Belgium), we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Self-Study Programme:


A self-study programme is a service provided electronically. It is the period of self-study that is the most important in our self-study Basics of Health Economics and not the kickoff and closing webinars. As a result, this self-study program follows a different VAT application and the place of the service is where the customer is established. Therefore, we follow the VAT rules applicable to the country of your invoicing address.

 

Group Discounts

Team discounts can be offered to 3 or more delegates from the same company.

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

Transfer & Cancellation Policy

Flexible Transfer

  • If a registrant cannot attend the scheduled course, he/she can avoid any cancellation charge by sending a suitable replacement participant.

  • Alternatively, the registrant can transfer once on a “space available” basis at no extra cost, until 3 weeks prior to the event, to another course of the same value held within one year of the original course date.

Registration Cancellation

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

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

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

  • If a registrant postpones his/her participation to a future course, and cancels again, no refund can be claimed for registration fees.

 

Benefits of CELforPharma’s face-to-face courses:

  • You have the unique opportunity to interact 1:1 with the expert(s).

  • Plenty of opportunity for informal 1:1 and group conversations with your international peers to exchange experiences and ideas, to discuss issues and to network.

  • Face-to-face interactions allow for more depth during Q&As and group work.

  • You can step away from your daily routine in the office and enjoy a more focused learning experience in a comfortable business hotel environment.

 

Benefits of CELforPharma’s live online courses:

  • The formal programme is as impactful as a face-to-face course thanks to the highly interactive format (using breakouts, polls, quizzes …).

  • No travel & accommodation expenses

  • You can attend the course from the comfort of your own office or home.

  • We send you the course materials by post so that you can take notes and fully engage with the course content.

No, if you choose credit card payment, we will send you a secure payment link together with the invoice.

Team discounts can be offered for 3 or more registrations confirmed at the same time. The level of discount will depend on the number of registrations and the availability of seats.

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

Depending on the format of the course (face-to-face in Brussels or live online or self-study programme) and your location, we are obliged by Belgian law to apply VAT in the following cases:

Face-to-Face public course organised in Belgium


Article 53 of the European Union VAT Directive 2006/112 states that : “The place of supply of services in respect of admission to cultural, artistic, sporting, scientific, educational, entertainment or similar events, such as fairs and exhibitions, and of ancillary services related to the admission, supplied to a taxable person, shall be the place where those events actually take place.” 
If the course that you register for takes place in Belgium, we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Online Public courses -  live webinar


Webinars where the participants can communicate among themselves or ask questions to the speaker(s) (be it verbally, via a chat function or similar), are considered as ‘online interactive webinars’ by the Belgian VAT administration. 
According to Article 53 of the European Union VAT Directive 2006/112, these online interactive webinars take place where the organisation of the seminar takes place, which in this case is Belgium. 
So, if you register for one of our live online courses (organised from our offices in Belgium), we are obliged to charge 21% Belgian VAT. 
However, you can recover this Belgian VAT through the refund procedure. Note that this procedure differs depending on the country where you are located. It is best to contact your local VAT administration for this.
 

Self-Study Programme:


A self-study programme is a service provided electronically. It is the period of self-study that is the most important in our self-study Basics of Health Economics and not the kickoff and closing webinars. As a result, this self-study program follows a different VAT application and the place of the service is where the customer is established. Therefore, we follow the VAT rules applicable to the country of your invoicing address.

Our face-to-face courses in Brussels and Zurich take place in four-star business hotels close to the airport. As part of our strong relationship with these hotels, CELforPharma has secured a discount on the daily room rate for our delegates who book their accommodation via us. 

Upon your registration, we will assist you to make your hotel booking. For any assistance in this matter please do not hesitate to email Kealeigh Steel, Senior Programme Coordinator, or contact her by phone at +32 2 709 01 45. 

We do not record our live online public courses as we want to offer a safe environment for all attendees to share their experiences and freely ask questions.

This way, by participating in our courses, you do not only learn from our expert faculty but also from your international peers in the room.

No, we don't sell the course materials as a stand-alone. 
Without the expert's explanation, the exercises and the discussions with other course participants, there is very little value in the slides.

Email Inge Cornelis, partner with CELforPharma, to help you choose the course that is best suited. 

Yes! 

We have helped many managers with setting up an in-house training programme for their team. 

Email Inge Cornelis, partner with CELforPharma, to discuss your team training needs.

Do you have any other questions? 
Email Annelies Swaan or call +32 2 709 01 42.

By clicking the below button, you will save this course to MY COURSES in the upper right corner of the website. This allows you to quickly retrieve it later. 

Don’t forget to make a personal account using the Login button in the upper right corner of the website to keep your list of saved courses for your next visit.

Dates & Locations

29 November 2023

Live online

Register