c4c expert advice, patient and public involvement, data standards

“Conect4children” (c4c) is a IMI2 project and a Dutch non-profit that provides services to academia and industry that accelerate the design and conduct of paediatric clinical research. This webinar introduces two of the services: expert advice about the design of paediatric trials, including the voice of children, young people, and data standards. We invite you to learn about how these services can support your research, adapt your work to the paediatric population, and how you can inform the implementation of c4c for rare disease research.

Mark Turner, c4c

Fenna Mahler, c4c

Pamela Dicks , NHS Scotland Childrens Research Network and eYPAGnet

Becca Leary, University of Newcastle.

The webinar will be introduced by Prof. Mark Turner, the CEO of the non-profit. The expert advice services will be described by the service lead Fenna Mahler who will outline services for expert advice about trial design including methodology, endpoints, standard of care, and national specificities. The approach to listening to the voices of children, young people, and families will be outlined by Pamela Dicks who will describe how Patient and Public Involvement experts design and facilitate consultations that are specific to the requirements of each trial, while meeting the needs of the parents and young patients who participate. The work on paediatric data standards will be described by Becca Leary who will outline how data standards for clinical trials have been adapted to paediatrics and how other data standards can be supported to account for paediatric specificities.

Prof. Mark Turner is CEO of the Dutch non-profit conect4children Stichting. With more than 30 years clinical practice in neonatal medicine, he has spent 15 years developing infrastructure for clinical research including involvement in EJP-RD and EURODIS initiatives.

Fenna Mahler is the Head of Operations and the Lead for Expert Services of conect4children Stichting. She has over 15 years in clinical research within industry and academia, she led the co-development of the Expert Services in the c4c project

Dr Pamela Dicks is the Manager and PPI lead of the NHS Scotland Childrens Research Network and founder and member of the Steering Group of the European Young People’s Advisory Group Network (eYPAGnet). Pamela has more than 15 years experience managing a broad portfolio paediatric clinical trials, and in patient and public involvement with children and young people

Becca Leary is a Senior Project Manager with the University of Newcastle. with extensive experience of delivering European projects with a focus on Rare Diseases and Drug Development.