All Insights

From hemp to highs: an overview of cannabis and CBD legislation across Europe

Thu, 04 Jul 2024 11:26:26 +0100

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What are the key differences and overlaps across the European regulatory frameworks?

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From doctoral research to spin-out: a UK tech start-up's VC-backed international journey

Wed, 03 Jul 2024 09:48:16 +0100

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IP, networking and seeking advice have been areas of focus for a chemical tech start-up on its path to fundraising

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Products | UK Regulatory Outlook June 2024

Wed, 26 Jun 2024 10:09:13 +0100

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UK general election 2024: product regulation aspects

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UK general election: what are the potential implications for the life sciences and healthcare sector?

Tue, 25 Jun 2024 10:28:48 +0100

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The Conservative and Labour parties both acknowledge the sector's importance to the UK's economic growth, but what plans do they have for its future?

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Italy | Health and data processing for research purposes: safeguards to adopt when data subject consent cannot be obtained

Tue, 25 Jun 2024 08:56:15 +0100

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A recent law has simplified procedures for conducting retrospective observational studies

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EU AI Act's 'deployers' definition has wide-ranging significance for life sciences

Wed, 19 Jun 2024 11:01:24 +0100

Identifying businesses as deployers of high-risk AI systems is crucial for understanding new regulatory responsibilities

Government updates guidance on the UK National Security and Investment Act

Wed, 05 Jun 2024 10:48:31 +0100

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Changes cover call-in powers, universities and research bodies, outward direct investment and notification forms

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Low-risk AI bears high stakes for digital health in new EU regulation

Wed, 15 May 2024 09:10:14 +0100

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Life sciences providers of low- or medium-risk AI will also be subject to the EU AI Act

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UK Medicines and Healthcare products Regulatory Agency outlines AI strategy

Fri, 10 May 2024 15:38:52 +0100

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The MHRA has published its response on how it is aligning with the principles of the AI regulation white paper

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A new CE marking for European healthcare: when and why?

Wed, 08 May 2024 08:17:34 +0100

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The EU AI Act's new CE-marking regime for high-risk systems has implications for life sciences and healthcare businesses

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Future Foods Update | May 2024

Fri, 03 May 2024 14:42:06 +0100

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This edition includes new UK guidance on plant-based dairy products, an Austrian case on naming plant-based products, and EU developments on lab-grown meat.

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High-risk AI systems in life sciences face strict regulatory scrutiny from new EU rules

Thu, 02 May 2024 08:24:21 +0100

Businesses should consider if and how AI is used internally or externally and get ready for the risk-based approach

New AI legislation's reach extends into European healthcare

Wed, 24 Apr 2024 08:33:58 +0100

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What impact could the sector-neutral EU AI Act have on public health and patient care across Europe?

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The UK is developing its approach to deregulating gene editing in plants

Mon, 22 Apr 2024 10:05:00 +0100

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The UK has pursued a post-Brexit deregulatory agenda via new legislation but has it failed to capitalise on the changes?

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New EU AI Act is poised to shape the future for life sciences in Europe

Tue, 16 Apr 2024 12:33:59 +0100

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What is the extent of the sector's application of AI and the regulatory outlook following European Parliament approval?

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European Parliament formally adopts Product Liability Directive

Fri, 12 Apr 2024 14:21:12 +0100

What changes and practical actions should businesses be considering?

Setting sail globally: launching internationally in an interconnected world

Wed, 10 Apr 2024 15:42:37 +0100

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Launching a business internationally can be a game-changer but comes with its own set of challenges and considerations

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UK government unveils draft procurement regulations for public sector bids

Thu, 04 Apr 2024 11:17:51 +0100

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Authorities and suppliers will need to keep an eye on information published about procurements and resulting contracts

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Decision time for UK medical device regulation: diverge or converge with the EU?

Thu, 28 Mar 2024 17:16:10 +0000

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The MHRA appears to be considering an approach for UK regulations that would broadly mirror the EU model

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Medication advertising in the digital age

Mon, 25 Mar 2024 15:55:41 +0000

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The Generalitat of Catalonia has updated its guide to advertising medicines for human use with a focus on digital advertising

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What qualifies as a legitimate reason to object to parallel trade of medicines in Europe?

Wed, 20 Mar 2024 16:35:13 +0000

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Trade mark owners are able to object to the parallel trade of medicines provided that there are legitimate reasons

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What are the patentability implications of deregulating gene editing in plants in the EU?

Fri, 15 Mar 2024 13:26:38 +0000

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The European Parliament has voted to embrace more flexibility in the regulation of gene-edited plants but has proposed a ban on patents

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Navigating Belgium's life sciences terrain: a strategic overview

Wed, 13 Mar 2024 10:36:07 +0000

Insights into regulations, trends, and strategic pathways for the pharmaceutical, medical device and food (supplement) industries

EU assesses competition picture of the pharma sector

Thu, 07 Mar 2024 08:39:55 +0000

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Commission reports to the Council on how EU antitrust and merger rules in the pharmaceutical sector have been enforced in the period 2018-2022

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The UK Procurement Act 2023 brings new rules for frameworks and dynamic markets

Mon, 04 Mar 2024 11:37:41 +0000

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The changes that are set to be introduced later this year could prove useful for both suppliers and authorities

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