Last week’s round-up, 20-24 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   EMA Consults on GMP Reflection Paper 24 January 2020 The EMA has just released a draft reflection paper on good manufacturing practice (GMP) and marketing authorisation holders (MAHs), which is open for public consultation until 17th April 2020. The paper focusses on clarifying the GMP responsibilities […]

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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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