Introduzione
Course linked to Patient Partnering in Clinical Development
How to best integrate Patients into your Strategies and Operations in Clinical Development - STEP IV
28 September 2021 - Online
Discover the Agenda https://lsacademy.site-dev.it/en/product/patient-partnering-clinical-development/
Remote or decentralized trials are currently a hot topic; 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 really make up their mind whether to participate or not?
- 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 address 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.
Topics:
Overview of Patient Involvement at FDA and EMA
– Patient Focused Drug Development Guidance and practice by FDA.
– Recommendation guidance and practice by EMA.
Case Study and Break Out session 1:
– Patient involvement in the design of a decentralized clinical trial (patient relevance impact & opportunities – e.g., diversity, ethical/privacy elements, endpoints etc.).
Proven methodologies and tools for patient involvement I
Case Study and Break Out session 2:
– Patient involvement in the design of a decentralized clinical trial (practical & logistical impact – e.g., patient enrollment & retention, telemedicine etc.)
Proven methodologies and tools for patient involvement II
Break Out session 3:
– Moderated group work on conclusions and results (key take-home learnings & ideas) from the training session.
Small Biotech / Start-up Leadership (IND/clinical stage), Clinical Operations, Clinical Development, R&D Strategy, Patient Affairs/Relations, Patient Experts, and those who want to become one, Medical Affairs, R&D Project Management.
Case studies, procedures, and methodologies tools for use in practice.
Highly interactive moderated exchange of practical experience regarding challenges and solutions.
Break out working sessions, including preparation of presentation of practical learnings and conclusions for full conference audience next day.
Docente/i
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.
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.
Online Training – 1 module
27 September 2021 from 2:00 pm to 6:00 pm CEST
After the registration, 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.
Early Bird: € 440,00* (until 06 September 2021)
Ordinary: € 590,00*
Freelance – Academy – Public Administration**: € 265,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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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.