All Insights
Showing 1 - 12 of 204
IT and data
How the European Court of Justice is shaping health data anonymisation
A recent ruling gives valuable legal guidance on personal data but what are the practical implications for healthcare?
15/09/2023
Life Sciences and Healthcare
EU's 'flexible' pharma reforms likely to require fine-tuning to address uncertainties
The reduction of the regulatory data protection period and wholesale distribution changes raise some industry concern
12/09/2023
Life Sciences and Healthcare
EU to reform rules for drug-device combinations, product information and pharmacovigilance
The proposal's eight-week consultation has allowed the sector to assess the draft legislation in these and other areas
05/09/2023
Life Sciences and Healthcare
EU pharmaceutical reforms to overhaul marketing and manufacturing rules
Advertising, marketing authorisation applications and imports are among the areas targeted by the draft proposals
29/08/2023
Artificial intelligence
What risks need to be considered by a UK business using artificial intelligence?
An overview of the legal and regulatory risks arising from AI deployment published in our article in Compliance & Risk
17/08/2023
Regulatory and compliance
UK government heralds 'indefinite' CE marking recognition in GB market
Businesses will still need to look carefully at regulations and determine if a UKCA or CE mark is more appropriate
03/08/2023
Digitalisation
Neurotechnology advances pose discriminatory and privacy risks, warns the UK's ICO
The global brain-monitoring technology market could be worth $17.1bn by 2026 but will bring ethical and legal challenges
10/07/2023
Life Sciences and Healthcare
Judicial review highlights pharmaceutical industry concerns over VPAS in UK
Negotiations for new voluntary scheme being challenged by industry body as old scheme is criticised for amount levied on suppliers
30/06/2023
Regulatory Outlook
Products | UK Regulatory Outlook June 2023
General Product Safety Regulation enters into force | Council of the EU adopt position on new Product Liability Directive |
28/06/2023
Life Sciences and Healthcare
UK gives guidance for manufacturers on reporting adverse SaMD incidents
Businesses should consult the guidelines and familiarise themselves with the issues to report and systems to implement
26/06/2023
Life Sciences and Healthcare
Use of trade mark for food supplements does not amount to genuine use for pharma products
Food supplements are not considered as a sub-set of pharmaceutical products in class 5 for proving genuine trade mark use
15/06/2023
Life Sciences and Healthcare
Pharma impacted by new EU packaging and packaging waste proposals
The European Commission concludes its feedback period from stakeholders on its draft regulation
06/06/2023
