Introduzione
Patient Engagement has become a reality that can no longer be ignored in clinical drug development.
Many initiatives and regulatory bodies have issued guidances, toolboxes and other materials to further professionalize Patient Engagement within the industry.
The goal of this training course is to provide a practically driven overview and insights on Patient Engagement from history, current status towards future perspectives.
It will provide clear do’s and don’ts regarding Patient Engagement and practical approaches towards fruitful collaborations with individual patients, patient organisations and alliances.
This course will look into the overarching principles, available guidelines & initiatives in Europe on Patient Engagement in Clinical Drug Development as well as an outlook for the future.
This course 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.
The following key elements will be part of the programme:
- 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
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
Interactive training course, to put learning into practice
Docente/i
Roger Legtenberg
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
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 online training consists of 1 module:
11 October 2022 from 9:30 am to 1:00 pm CEST
Some days before the online training you will receive all details about the connection.
The course 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.
This course is part of a training path, for more information visit the web page
Patient Engagement in Clinical Development
Early Bird: € 430,00* (until 27 September 2022)
Ordinary: € 560,00*
Freelance – Academy – Public Administration**: € 325,00*
* 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 and attendance certificate that will be sent after the training via e-mail.
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Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.