About

This training path consists of four half-day modules structured to become a practical guidance towards making patient engagement in clinical development relevant for patients.

It starts off with a solid foundation on patient engagement in drug development with practical approaches on how to fruitfully collaborate with individual patients, patient organisations and alliances.

Then it dive into the value of patient engagement to ensure that the clinical trial design and the practical execution of those trials is optimized. Setting up decentralized elements in the right way within the study design is also covered to avoid hypes and create value for patients and sponsors.

Moreover, decentralization is taken to the next level by providing insights and practical guidance to decentralize patient recruitment thereby enhancing enrollment and how patient engagement can increase retention. To close the training path is focused on how patient engagement can play a significant role to enhance diversity within clinical trials, which is one of the biggest challenges in running them.

MODULE 1 | Introduction to Patient Engagement in Clinical Drug Development
11 October 2022 from 9:30 am to 1:00 pm CEST

This module will look into the overarching principles, available guidelines and initiatives in Europe on Patient Engagement in Clinical Drug Development as well as an outlook for the future.

It will highlight the importance of Patient Engagement and provides for a basic understanding of Patient Engagement throughout the drug development lifecycle, also following the recent FDA guidance for PFDD (patient focused drug development) and recommendations of the EMA.

  • Principles, guidelines & initiatives in Europe (from history to future outlook)
  • Overview of best practices / processes to achieve patient relevance in clinical development
  • Different roles of patient organizations /communities to drive clinical drug development
  • Case studies

MODULE 2 | Patient Engagement and Decentralized Clinical Trial Designs
21 October 2022 from 9:30 am to 1:00 pm CEST

This module will look into methodologies of patient partnering and patient engagement before and during the design of your clinical trial.
The focus will be on remote / decentralized trials.

  • ‘Patient focused drug development’ regulatory landscape
  • Challenges with clinical trial designs and how to overcome these with Patient Engagement
  • Differentiating between hype and actual patient value of remote/decentralized parts of clinical trials
  • Defining different methodologies to obtain practical patient insights to improve decentralized/hybrid designs and conventional designs
  • Best practice and typical traps
  • Case studies

MODULE 3 | Patient Engagement and Clinical Trial Recruitment and Retention
09 November 2022 from 9:30 am to 1:00 pm CET

This module will give insights in the current reality of recruitment and retention challenges for clinical trials and how Patient Engagement can play a key role into (partly) overcoming these challenges. Insights in finding the right balance between technology, digital apps and human interaction to support patients to fit their needs will be addressed.

This course will navigate you through materials, methodologies, procedures and tools that can be used in real-practice to address recruitment and retention challenges for clinical trials.

  • Overview of current reality of clinical trial recruitment and retention
  • Role of Patient Engagement to improve recruitment and retention
  • How to empower, enable and assist patients to fit their needs (appropriate use of technology, digital apps and human interaction)
  • Practical guidance and approaches how typical recruitment and retention issues can be resolved in a patient relevant way
  • Case studies

MODULE 4 | Patient Engagement and Enhancing Diversity in Clinical Trial Participation
22 November 2022 from 9:30 am to 1:00 pm CET

This module will give insights in the history, current situation and future possibilities and needs regarding diversity in clinical trials. In a step-wise approach several of the challenges associated with diversity in clinical trials will be addressed from a Patient Engagement perspective with practical tools / methodologies that could be implemented.

  • History, status quo and outlook for diversity in clinical trials
  • Regulatory initiatives to enhance diversity
  • Understanding of different types of diversity & associated needs of patients (underprivileged groups, ethnic minorities, age and health sub-groups)
  • Practical guidance and approaches towards enhancing diversity in clinical trials through patient / citizen engagement
  • Do’s and Don’ts / typical traps for addressing diversity aspects

Other senior staff members from admedicum and internationally renowned patient representatives may be added to the team.

Clinical Operations, Clinical Development, R&D Strategy, Patient Affairs/Relations, Patient Experts, Medical Affairs, R&D Project Management belonging to pharmaceutical, biotech companies and academia.

Participant experience
No previous experience in patient engagement is necessary. Basic knowledge on clinical development is preferred.

Case studies, procedures and methodology tools for use in practice.
Moderated exchange of practical experience regarding challenges and solutions.

Lecturers
Roger Legtenberg
Info

Roger Legtenberg

Senior Partner admedicum Business for Patients and former CEO of a CRO
Roger J. Legtenberg, Ph.D. is a Senior Partner & Head of Benelux Region at admedicum Business for Patients, experts in patient engagements and patient access to innovative services and products. Roger is the former CEO of PSR Orphan Experts, a rare disease specialized CRO, as well as a former senior executive in biotech & medtech companies. With over 20 years of experience in clinical trials and a strong passion to reduce time for patients to new effective treatments he is currently accelerating patient-focussed drug development within admedicum. Roger obtained a Ph.D. in Cardiovascular Physiology from the University of Nijmegen, the Netherlands.  

Philipp von Gallwitz
Info

Philipp von Gallwitz

Co-Founder admedicum Business for Patients and Patient Activist CDKL5
Philipp is Managing Partner and one of 2 co-founders of admedicum Business for Patients, European experts in patient engagements and patient access. In this function and as a father to a 20-year old daughter living with the rare genetic disease CDKL5 he has been passionately advocating for involving the patient view in research & development since many years. He is a member of the patient expert pool of the European Innovative Medicines Initiative (IMI). While working with patients and patient organizations every day Philipp has gone through a 20 year long international management career with Grünenthal GmbH in Europe, USA and Latin America, being closely involved in many clinical development programs. He is a lawyer by training, registered at the bar of Cologne, Germany.

This training path is made of a series of four standalone courses. Visit each course online brochure for more information

Introduction to Patient Engagement in Clinical Drug Development
11 October 2022 | 9:30 am – 1:00 pm CEST

Patient Engagement and Decentralized Clinical Trial Designs
21 October 2022 | 9:30 am – 1:00 pm CEST

Patient Engagement and Clinical Trial Recruitment and Retention
09 November 2022 | 9:30 am – 1:00 pm CET

Patient Engagement and Enhancing Diversity in Clinical Trial Participation
22 November 2022 | 9:30 am – 1:00 pm CET

After the registration, you will receive all details about the connection.

Each online training will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Super Early Bird: € 1.315,00* (until 14/08/2022)

Early Bird: € 1.495,00* (until 12/09/2022)

Ordinary: € 1.890,00*

Freelance – Academy – Public Administration**: € 1.105,00*

* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials for each training and attendance certificate that will be sent after the complete training path via e-mail.


Book Now
Super Early Bird
Available until 14/08/2022
1.315,00
Early Bird
Available until 12/09/2022
1.465,00
Ordinary
Available until 10/10/2022
1.890,00
Freelance – Academy – Public Administration
Available until 10/10/2022
1.105,00
Clear

Printable Version
At the end of the training path, you will be able to
Risultato atteso
Differentiate between what is patient engagement and what it is not
Risultato atteso
Differentiate between hype and actual value of remote/decentralized parts of a clinical trial
Risultato atteso
Identify Patient Engagement opportunities during all stages of a clinical trial and how these can affect clinical trial recruitment and retention
Risultato atteso
Understand how diversity could be enhanced for clinical trials by using Patient Engagement approaches

<p>Online training path on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before each module.</em></p>

Online training path on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before each module.

<p>Online training path on Zoom platform.</p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before each module.</em></p>