Essentials of Paediatric Clinical Research – 12 September 2023 (Webinar)
Workshop Topic
Essentials of Paediatric Clinical Research – What you need to know when preparing, conducting and monitoring paediatric clinical trials
Workshop Date & Time and Venue
12 September 2023 from 08:00 AM to 04:30 PM (CEST)
Bambino Gesù Paediatric Hospital, Sede San Paolo
Viale Ferdinando Baldelli, 38
Rome, Italy
Training Objective
Give an overview of the regulatory landscape for paediatric research, review specifics and most important challenges with corresponding solutions in paediatric drug development and review specifics and most important challenges with corresponding solutions in paediatric drug development.
Following the training, the participants will be familiar with the ethical and regulatory issues, specific protocol considerations and age groups, Informed Consent and Assent processes, drug formulations, safety specificities, recruitment, enrolment, and clinical monitoring specificities, as well as site interactions, relationships with paediatric research networks and infrastructures. Participants will be prepared to plan and execute paediatric clinical trials in any of the age groups which will result in obtaining higher quality data.
Target Attendees
Clinical Research Associates (CRAs)
Central Monitoring Associates (CMAs)
Study Start Up and Regulatory Affairs personnel
Clinical Trial Managers (CTMs)
Project Managers
Project Directors
Patient enrollment and retention specialists
Any person involved in paediatric drug development.
Training Material and Training Certificate
A copy of the presentations will be provided as PDF version (available to be downloaded following password receipt).
A training Certificate will be delivered.
Speakers
Paolo Rossi, Professor of Paediatrics at Bambino Gesù Paediatric Hospital/ University of Rome Tor Vergata & Director of the Hospital Paediatrics Department, Bambino Gesù Paediatric Hospital, Italy
Martine Dehlinger- Kremer, President, EUCROF & VP Scientific Affairs, Paediatric SME, Center for Paediatric Clinical Development, Drug Development Solutions, ICON Plc, Germany
Fabio D’Atri, Policy Officer, Deputy Head of Unit B5 Directorate General for Health and Food Safety, European Commission, Belgium
Nira Garty, CEO, Perfection CRO, Israel
Alex Cvetkovic Mutañola, Executive Director Clinical Development Syneos Health, Spain
Ian Vasicka, Clinical Investigator, Charles University, Prague, Czech Republic
Ricardo Fernandez, CMO at conect4children-Stichting, Portugal
Claudio Fracasso, Paediatric Clinical Director, Pfizer, Italy
Donato Bonifazi, EPTRI (European Paediatric Translational Research Infrastructure) Coordinator and CEO, CVBF, Italy
Viviana Giannuzzi, Senior Researcher at Fondazione per la Ricerca Farmacologica Gianni Benzi ONLUS, Bari, Italy
Alessandra Simonetti, Bambino Gesù Paediatric Hospital and University of Tor Vergata, Rome, Italy
Jürgen Schäfer, Managing Director, Conreso GmbH, Germany
Giuseppe Pontrelli, Bambino Gesù Paediatric Hospital, Rome, Italy
Agenda
08:00 – 08:15
Registration
08:15 – 08:30
Opening Remarks
Paolo Rossi, Bambino Gesù Paediatric Hospital
Martine Dehlinger-Kremer, EUCROF & ICON Plc
Session 1:
Regulatory Paediatric Drug Development
08:30 – 09:00
Global Regulatory and Ethical Considerations for Paediatric Drug Development
Martine Dehlinger- Kremer, EUCROF & ICON Plc
09:00 – 09:30
Impact of the proposed new EU Pharmaceutical Legislation on Paediatric Developments
Fabio D’Atri, European Commission
09:30 – 10:00
Medical Devices in Paediatric Research
Nira Garty, Perfection CRO
10:00 – 10:30
Coffee break
Session 2:
Medical Considerations of paediatric research
10:30 – 11:30
Differences between Children and Adults, specifics of the different paediatric Age Groups and impact on Study Protocols & Assessments Drug Formulation specificities and administration
Alex Cvetkovic Muntañola, Syneos Health
11:30 – 12.00
Safety Considerations in Paediatrics including Covid considerations
Ian Vasicka, Clinical Investigator
12:00 – 13:00
Lunch
Session 3:
Medical sites and Patient recruitment networks
13:00-13:30
Conect4children (C4C), Paediatric network
Ricardo Fernandez, CMO at conect4children-Stichting
13:30-14:00
Role of young people advisory organisations in paediatric research
Claudio Fracasso, Pfizer
14:00-14:30
European Paediatric Research Networks and Infrastructures
Donato Bonifazi, EPTRI and CVBF
Session 4:
Monitoring and Safety
14:30 – 15:00
ICF and Assent: Specific process per Age Group
Viviana Giannuzzi, Benzi Foundation Alessandra Simonetti, Bambino Gesù Paediatric Hospital
15:00 – 15:30
Specific Study Monitoring considerations for Paediatric Trials
Jürgen Schäfer, Conreso
15:30 – 15:45
Coffee break
15:45 – 16:15
Important Aspects of Paediatric Trials from the Clinical Site perspective
Giuseppe Pontrelli, Bambino Gesù Paediatric Hospital
16:15 – 16:30
Closing Remarks
Martine Dehlinger-Kremer, EUCROF & ICON Plc
Attendance Fee
Early Bird Fee until 17 July 2023
280 €
240 € for EUCROF Members
After 17 July 2023
330 €
280 € for EUCROF Members
How to register?
1) Go on the REGISTRATION PAGE and click on the red button “RESERVE A SPOT”
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Confirmation
You will receive confirmation emails from Eventbrite with your invoice
Questions?
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