Module232025

5/7/2025

Thank you!

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• Use of extrapolation in the development of medicines for paediatrics https://www.ema.europa.eu/en/documents/scientific guideline/adopted-reflection-paper-use-extrapolation-development-medicines-paediatrics-revision-1_en.pdf • ICH Guideline E11A on Pediatric Extrapolation https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich guideline-e11a-pediatric-extrapolation-step-2b_en.pdf • ICH Topic E 11 Note for guidance on clinical investigation of medicinal products in the paediatric population http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf • ICH E11(R1) Guideline on clinical investigation of medicinal products in the pediatric population EMA/CPMP/ICH/2711/1999 https://database.ich.org/sites/default/files/E11_R1_Addendum.pdf • State of paediatric Medicines in the EU -10 years of the EU Paediatric Regulation; Report from the Commission to the European Parliament and the Council; COM (2017) 626 https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf • How to better apply the Paediatric Regulation to boost development of medicines for children. Report on a multi-stakeholder workshop held at EMA on 20 March 2018 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000023.jsp&mid=WC0b01ac058 0b18c75

References

Adolescent inclusion decision tree https://efgcp.eu/resources/workingparties/1/EFGCP_Adolescent%20Inclusion%20Decision%20Tree_FINAL.pdf

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• EnprEMA Guidance on Preparedness of CT in paediatrics https://www.ema.europa.eu/en/documents/other/preparedness medicines-clinical-trials-paediatrics-recommendations-enpr-ema-working-group-trial_en.pdf • EMA Guidance for Stepwise PIP pilot https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance stepwise-pip-pilot_en.pdf

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