A 1-Day Training Course Delivered by
Radek WasiakThomas Wilke

Dr. Radek Wasiak and Prof. Dr. Thomas Wilke

  • Thought & business leaders at Cytel, a leading provider of design and implementation services in the field of clinical trials and real-world evidence studies.
  • As Head of Real World and Advanced Analytics business unit, Radek oversees a team of 180+ staff who design, execute, and disseminate RWE and HEOR projects.
  • Thomas has 20+ years of experience in leading and conducting German and international RWE studies. He is Cytel’s Principal Investigator, academic researcher, and author of numerous health economics articles.


  1. The fundamental concepts and principles for utilising Real World Evidence (RWE) towards optimising Market Access.
  2. The value RWE adds over Randomized Controlled Trials (RCTs) over a product’s entire lifecycle.
  3. The terminology used within the world of RWE, such as the exact difference between Real World Evidence and Real World Data (RWD).
  4. Why RWE is important to regulators, payers, physicians and pharma and how to tailor the evidence to their specific needs.
  5. The common sources of data available for RWE and how to assess the robustness of the data.
  6. The critical success factors when developing a RWE study.
  7. New developments in RWE.

Additional Benefits

  • Radek Wasiak and Thomas Wilke are available for Q&A during breaks and after the course so you can discuss challenges you are facing and get advice from experienced RWE experts.
  • Real-life case studies will be used to illustrate the theory and in small groups you will put the key learnings into practice on a real-world case study.


Why You Should Attend

RWE is a critical area of expertise in pharmaceutical companies, engaging various functions such as HEOR, Medical Affairs, R&D and Commercial. There are many challenges in the process of successfully implementing RWE. Executives participating in this open-enrolment course will contribute much more effectively in the cross-functional organisation that RWE requires. This course covers the basics required to understand what RWE is, why it is important, who needs/uses it and how you can utilise it effectively to help your role. The content contains the recent developments on RWE, as well as real life case studies on how RWE can be used and potential challenges that can arise.

The Generating RWE for Optimising Market/Patient Access course is the only available public training course delivered by Dr. Radek Wasiak and Prof. Dr. Thomas Wilke on this topic.

Agenda of Generating RWE for Optimising Market/Patient Access

For start and end times, please check Dates & Locations below.

From RCT to RWD and RWE – A Continuum of Evidence (~1 h)

  • RWE defined
  • RWD – The reason why we see the explosion of RWE
  • The complementary role of RCTs and RWE in drug development

The Role of RWE and Stakeholder Perspectives Throughout the Drug Development Lifecycle (~1 h)

  • RWE and the regulatory bodies – The role of RWE during the regulatory process and post launch
  • RWE and payers – Pre- and post-launch applications - Global vs. local and how to organise
  • Why should HCPs care about RWE?
  • ‘It’s actually my data’ – The role of the patient

Typology of RWD Sources: Strengths & Weaknesses (~45 min)

  • Existing data sources:
    • Electronic medical records
    • Claims data
    • Healthcare wearables & social media
  • Bespoke data sources
    • Patient registries
    • Pragmatic studies
    • Observational studies
    • Surveys
  • Geographic differences in access and content across data sources

Lunch Break

Critical Success Factors of a RWE Study (~1 h)

  • Define the right questions by considering (and engaging!) stakeholders, their needs and alternative approaches
  • Identify the most robust and accessible data source – How to assess the data sources
  • Determine a robust data generation methodology
  • Use best-practice guidelines on study design
  • Ensure you use a pre-specified robust statistical analysis plan
  • Effectively communicate RWE to the various stakeholder types

Interactive Group Exercise: How to Build an Effective RWE Generation Plan (~1 h 30 min)

  • Considering a recently launched drug, evaluate how RWE was or could have been used to support the regulatory and reimbursement process.
  • Group output will be discussed in plenary and experts will close with their expert opinion.

The Next Frontiers: ‘Live RWE’ (~30 min)

  • Predicting outcomes: The promise of machine learning
  • Causal inference: Do drugs really work in real-world treatment populations?

Wrap-Up & Closing (~15 min)

>> Click here if you wish to receive the PDF brochure of this course

Learning Methodology

This course is designed to stimulate interaction and optimally engage all participants by asking input prior to the course with a small pre-course questionnaire (by email), polling and Q&A, as well as with an interactive group exercise.

You will not only learn from the experts´ recommendations based on their vast experience in developing RWE research solutions for Market Access, but also from discussing issues and exchanging experiences with your peers from other companies and countries.

One of the most valuable aspects of attending any CELforPharma course is not only being able to have your specific questions answered by leading experts, but also having the opportunity to share experiences and have in-depth discussions with your international peers.

infoThe typical audience size of our courses ranges from 6 to 20 (max) participants.

Who Should Attend?

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

As this course is delivered by Dr. Radek Wasiak and Prof. Dr. Thomas Wilke from Cytel, executives from other professional service agencies should request approval prior to registering for this course. Please contact Annelies Swaan, Director Business Operations, for more information (aswaan@celforpharma.com, tel +32 (0)2 709 01 42).


Past Participants

As this is the first session of the Generating RWE for Optimising Market/Patient Access course, there is no past participants list available.



As this is the first session of the Generating RWE for Optimising Market/Patient Access course, there are no testimonials available.

Dates & Locations

Currently this CELforPharma course is planned to only be held live online (hosted in Zoom).​​​​

The start and end times for all below sessions will be: 09:30 - 16:30 CET (Brussels/Amsterdam/Paris).​​​​

  • 13 June 2023, live online

  • 28 September 2023, live online

  • 29 November 2023, live online

Included in the Registration Fee​

  • Access to a 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, which 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.


How to Register

  1. Click the "Register Here" button on this page.
  2. Choose a course date, then fill out your personal details and company / invoicing details.
  3. Choose to pay via bank transfer or by credit card (through a secure payment link, which you will receive together with the invoice).
  4. Click "Confirm Registration". You will be sent an automatic email confirming your registration followed by a personal email containing an invoice and further payment instructions.

For assistance in registering, raising a PO or invoicing, please do not hesitate to contact Kealeigh Steel.
(email: kealeigh.steel@celforpharma.com or call: +32 2 709 01 45)


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.