1. Paediatric Working Group
The European CRO Federation,
one voice towards clinical research
Paediatric Working Group
Chairman: Dr. Martine Dehlinger-Kremer

2. Initiatives & Achievements
Observing Member of Coordinating Group of Enpr-EMA
Guideline on Paediatric Informed Consent and Assent Form in the EU in collaboration with Ethics group of Enpr-EMA
Member of Industry & Network communication Working Group of Enpr-EMA
Attendance and contribution to the Annual Enpr-EMA Workshop Meetings
European Clinical Conference, Vienna, Feb 2018 – Session Paediatrics
Kiev Clinical Forum Conference, Kiev, Ukraine, Nov Presentation
Paediatric Conference Eastern Europe, Budapest, Nov 2017
EUCROF/RIPPS/EMA Conference: “Methodological Approaches to Overcome
the Challenges of Drug Evaluation in Children”, London, Apr 2013 – Organiser
25th DIA Europe, Amsterdam, Mar 2013, - Paediatric Session Chair & Presentation
EMA Workshop, London, Nov Presentation
EFGCP/DIA/EMA , London, Sept Presentation
Annual European Society of Paediatric Research Congress, Newcastle, Oct 2011
Poster Presentation
EUCROF/EFGCP: Workshop on Ethics In Paediatric & Geriatric Studies, Antwerp,
Apr Co-Organiser
EURO DIA, Monaco, Mar Presentation
EMA/TOPRA meeting, London, Dec Presentation
The mission of the EUCROF Paediatric Working Group is to contribute to the improvement of paediatric research by working on specific projects in collaboration with the different stakeholders, including the regulatory authorities, pharmaceutical/bio-pharmaceutical industry, academia, paediatric sites/paediatric networks, patients and patient advocacy groups. The working group also aims to increase knowledge related to paediatric clinical research.
Highlights
Established on 18th December 2007
Comprises 11 members from different countries
Represents and supports members’ interest towards the healthcare-related industry within the field of Clinical Research in Paediatrics
Recognised by European Medicines Agency (EMA) & National Regulatory Authorities and other stakeholders as the representative for EUCROF, regularly approached to contribute to the continuous debate on the improvement of paediatric rules and regulations.
Members
Germany
Martine Dehlinger-Kremer (Chair)
Jürgen Schäfer
Publications
“Pediatric Informed Consent and Assent Form: Current Status of Country Requirements” Applied Clinical Trials, October 2016
“How to Improve Clinical Research in Children: A Survey on the Perception of European Pediatricians and Industry/CROs.” Applied Clinical Trials, February 2014
“Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives”; Acta Paediatrica, 2011 Jul 6
“Ethical Challenges in Clinical Research at both ends of life”; Drug Information Journal, January 2011,Vol. 45, pp. 89–105.
“How to Improve Children’s Research”; Applied Clinical Trials, February 2010, p 46-53
“Testing Medicine for Children”; GCP Journal, July 2009, p 10-15
“European Pediatric Informed Consent and Assent Form: Current Status of Country Requirements “; Applied Clinical Trials, October 2016
Italy
Donato Bonifazi
Spain
Alex Cvetkovich Mutañola, MD Paediatrician
Greece
Sophia Romboli
Member in Israel (Nira Garty)
Consultants
Greece (Ian Vasiscka)
UK (Nuria Martinez & Dawn Gbekor)
Ukraine (Valentyna Telnova)
Netherlands
Erik Hamminga