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”

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?

Should you have any questions about registration, invoices or connection, do not hesitate and contact us by email at info@eucrof.eu

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