Volume 21, Issue 2 - Medical Writing in Paediatrics

Challenges of paediatric drug development and impact of paediatric legislation

Author: Klaus Rose

Abstract

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References

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20. European Medicines Agency decision P/91/2011of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for propane-1-sulfonic acid {3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide (RO5185426), (EMEA-000978-PIP01-10) [document on the internet]. 2011 [cited 2012 Feb 14] Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/pips/EMEA-000978-PIP01-10/pip_000701.jsp&mid=WC0b01ac058001d129
21. European Medicines Agency P/211/2011 of 2 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M04) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council. [document on the internet]. 2011 [cited 2012 Feb 14]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/pips/EMEA-000332-PIP01-08-M04/pip_000404.jsp&mid=WC0b01ac058001d129
22. Oral communication by Agnes Saint-Raymond at the Joint DIA/EFGCP/EMA Paediatrics Forum 2011: The paediatric regulation in its 5th year: Transition from toddler to school age. 26 & 27 September 2011 I De Vere Venues Canary Wharf, London, UK. Conference program on the internet. Available from: http://www.efgcp.eu/Downloads/confDocuments/DIA-EFGCP-EMA%20Paed.%20Conf%202011%20-%20Preliminary%20Programme.pdf