Workshop Topic
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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.
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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.
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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
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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 |
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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"
2) Check your order and click on the green "CHECKOUT" button
3) Fill in all the necessary information and validate your order
Confirmation
You will receive confirmation emails from Eventbrite with your invoice
Questions?
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