Introduzione
Remote or decentralized trials are a hot topic currently; among others, driven by the restrictions and concerns of patients and trial sites during the Covid-19 pandemic.
Industry is trying to find the right way to design trials with remote and decentralized virtual parts to enhance enrolment and keep retention high.
However….
How can we make sure that all the good ideas stand firm when those who must live through the clinical trial make up their mind really?
Do clinical trial participants really like to have a blood draw at home?
Do they trust the nurse coming to visit their child without a doctor?
Do they appreciate the advantages of e-ICF, regardless the disease?
This course 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. Still, the conclusions will be transferable to most other aspects of patient input into clinical trial design.
The course will navigate you through materials, methodologies, procedures and tools that can be used in real-practice to follow recent FDA guidance for PFDD (patient focused drug development) and recommendations of the EMA.
The following key elements will be part of the programme:
- ‘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
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
Basic knowledge on clinical development and in particular clinical trials is preferred.
In case of no patient engagement experience, following the course Introduction to Patient Engagement in Clinical Drug Development is advised, but not mandatory.
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:
21 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 23 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.
Registrati
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.