Understanding Clinical Trials, Protocols and Pharmacovigilance in Pediatrics

• What is a Clinical Trial? Manika Kreka
• An example of Clinical Trial Protocol Michela Semeraro
• Safety and Monitoring in Trials: pharmacovigilance in pediatrics, off-label use and side-effect monitoring Isabelle Desguerre

Patient Engagement in Clinical Trials

• Active Patient Engagement in Clinical Trials: PROMs PREMs and PIS Jessie Dubief
• Consent and assent in children: what’s the difference? Orenla Cullufe
• Consent/assent for processing personal data  Annagrazia Altavilla

Rare and Genetic Diseases specificities

• Challenges in diagnosis, research and care Célia Cretolle and Léa Tricaud
• Overview of rare and genetic diseases in pediatric patients Giulia Barcia and Emma Raimbault

Round Tables: How Can Patients Participate in Transnational Research Projects 

• Interactive exchange with young participants Annagrazia Altavilla, Suja Somanadhan, Inês Alves and Fatime Fejzullahu-Dërguti

Introduction to INVENTS and the decision matrix Donato Bonifazi

• What is a Patient Registry? Case discussion: Retrospective s Propective studies Nicole Chemaly
• Patients’ and Children Rights Annagrazia Altavilla, Leonardo Fiore and Eirini Daskalopoulou
• Clinical trials and how patients shape research – Advocates Empowerment Yanis Mimouni, Donato Bonifazi, Nicole Chemaly, Mark Turner and testimonials from Aaisha Seddika Mumminah, Charlotte Clerc and Valentina Jalby

Working session: Young Patients as Partners in Research

• Co-creation of a multi national study outline Yanis Mimouni, Donato Bonifazi, Nicole Chemaly and Mark Turner

Closing session

• Key learnings Emanuela Crea
• Participant feedback and evaluation session All participants
• Closing remarks Rima Nabbout and Donato Bonifazi