12 September 2023 - Essentials of Paediatric Clinical Research

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.



  • Paolo Rossi, Professor of Paediatrics at Bambino Gesù Paediatric Hospital/ University of Rome Tor Vergata & Director of the Hospital Paediatrics DepartmentBambino 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



08:00 – 08:15 


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


Session 3:

Medical sites and Patient recruitment networks


Conect4children (C4C), Paediatric network

Ricardo Fernandez, CMO at conect4children-Stichting


Role of young people advisory organisations in paediatric research

Claudio Fracasso, Pfizer


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

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