Last week’s round-up, 23 – 27 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   EU-China Working Group to Address API Manufacturing Concerns 27 March 2020 China’s National Medical Products Administration (NMPA) will be working with the European Commission’s DG Sante, the European Medicines Agency (EMA) and others to conduct a gap analysis between the Chinese and EU regulatory systems for […]

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COVID-19

Last week’s round-up, 09 – 13 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   Advice For Management Of Clinical Trials In Relation To Coronavirus 13 March 2020 In view of the current Covid-19 pandemic, the MHRA Inspectorate has released advice with regards to the management of clinical trials. Due to restrictions to limit the spread of the coronavirus, patients with […]

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Round-up, week 16 – 20 December 2019

Round-up, week 16-20 December 2019 By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   Pharmtech series of articles on Pharmacopoeia Compliance 16 December 2019 Pharmtech has published a  series of articles on Pharmacopoeia Compliance. The articles include: Why Pharmacopoeia Compliance Is Necessary Why Pharmacopoeia Compliance Is Difficult A Brief History of Pharmacopoeias: A Global Perspective […]

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Last week’s round-up, 11 -15 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry 15 November 2019 A recent survey shows wide adoption of ICH guidelines across regulators and industry. The survey collected responses from 32 pharmaceutical companies who provided information on 15 regulatory authorities, which ranged between ICH founding members, newcomers […]

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Last week’s round-up, 16-21 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Biotech in Europe: A Strong Foundation for Growth and Innovation 21 Sep 2019 What makes European biotech attractive, what financing does it need to fuel growth, and what should biotech leaders and investors do to succeed? These three questions are the focus of a recent review by McKinsey & Company. Their […]

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