AMPULES

Last week’s round-up, 24-28 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   European Pharmacopoeia updates testing for particulate contamination in pharmaceutical preparations 28 February 2020 The European Pharmacopoeia Commission has updated testing for particulate contamination in pharmaceutical preparations. General chapter 2.9.19. Particulate contamination: sub-visible particles, has been revised in order to supplement the Pharmacopoeial Discussion Group harmonised text, […]

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Last week’s round-up, 13-17 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   The Art of doing Clinical Regulatory well 17 January 2020 The landscape of clinical regulatory is becoming increasingly challenging to navigate, with over 8000 clinical trial applications in the EEA every year and increasingly diverse requirements to fulfil. These challenges have pushed clinical trial sponsors into […]

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Heartburn by Flickr user Christopher Dart

Last week’s round-up, 06-10 January 2020

By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   Decentralised Procedure – Requests to act as RMS 10 January 2020 National competent authority instructions for DCP RMS slot requests have been updated: http://bit.ly/RealGenerics-2NgpZTs   The Decade In Global Health: New Drugs, Faster Trials, Social Media To The Rescue 09 January 2020 When it comes to […]

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Last week’s round-up, 09-13 December 2019

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud Nitrosamine risk assessments for all substances for pharmaceutical use? 12 December 2019 The Ph. Eur. Commission has proposed an update to the monograph on Substances for Pharmaceutical Use, to introduce nitrosamine risk assessments for all substances (active substances and excipients), not only those obtained through chemical synthesis […]

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pills

Last week’s round-up, 14 – 18 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Updated product-specific bioequivalence guidance 18 Oct 2019 The EMA has finalised product-specific bioequivalence guidance for seven drug substances. The substances affected are alectinib, apixaban, cabozantinib, colchicine, ezetimibe, gefitinib, and palbociclib. All guidances were adopted on 15 October 2019. Those for apixaban and gefitinib will become legally effective on […]

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« Le Penseur » vu sur son côté droit by Flickr user couscouschocolat

Last week’s round-up, 26-30 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Particulate Contamination: sub-visible particles in non-injectable liquid preparations 30 Aug 2019 A new draft chapter on particulate contamination by sub-visible particles in non-injectable liquid preparations has been released by the EDQM, within Pharmeuropa 31.4. Two methods through which such particulate contamination can be detected are specified within it: a light obscuration […]

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