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

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. 2017 -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 2012 - Presentation EFGCP/DIA/EMA , London, Sept. 2012 - Presentation Annual European Society of Paediatric Research Congress, Newcastle, Oct 2011 Poster Presentation EUCROF/EFGCP: Workshop on Ethics In Paediatric & Geriatric Studies, Antwerp, Apr 2010 - Co-Organiser EURO DIA, Monaco, Mar 2010- Presentation EMA/TOPRA meeting, London, Dec. 2009- 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