Last week’s round-up, 30 September – 04 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Delays in treatment of requests for revision and renewal of CEPs 03 Oct 2019 The EDQM has communicated that it is currently experiencing some difficulty in achieving the assessment times for revisions and renewals of CEP applications. The delay is currently about 5 weeks and the EDQM has […]

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

By Tessa Fiorini-Cohen and Marthese Mifsud   Stella Kyriakides has been named the new European Commissioner for Health 13 Sep 2019 Kyriakides will preside over the implementation of the EU Medical Devices Regulation and the In Vitro Diagnostics Regulation. Ursula von der Leyen has specifically requested that the new commissioner focuses on effective implementation of this new regulatory […]

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Last week’s round-up, 02-06 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Has AI Discovered a Drug Now? Guess. 06 Sep 2019 The media is abuzz with reports that an artificial intelligence model has designed a drug in 21 days, however an opinion piece in Science Translational Medicine takes a more nuanced view. The software model is acronymed GENTRL (generative tensorial reinforcement learning), […]

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Last week’s round-up, 19-23 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Administrative Law Overview | RAPS 23 Aug 2019  A comprehensive overview of the United States’ federal administrative processes as related to regulatory affairs has recently become available on RAPS. The publication explains the Federal Register, Code of Federal Regulations, and the Administrative Procedures Act through which stakeholders can […]

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Last week’s round-up, 12-16 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   MHRA’s no-deal Brexit guidance 12 Aug 2019 Updates to the MHRA’s no-deal Brexit guidance have indicated a shift in the government’s willingness to leave without a deal. The guidances typically started with the following statement, which has now been dropped: “Leaving the EU with a deal remains the […]

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