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Life-Lines - Life Sciences through a legal lens

This week we look at a range of topics including the FDA’s proposed review framework for artificial intelligence-based medical devices.

Other highlights in this issue include:

  • Proposed cap on R&D tax credits may adversely affect life sciences SMEs
  • COCIR: advancing cybersecurity of health and digital technologies
  • Commission takes forward its work on ethics guidelines for AI

Brexit 

  • UK government updates plans for no-deal Brexit carbon tax
  • Export of medicines: certificate of a pharmaceutical product in no deal scenario
  • Conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice in a no deal scenario
  • New guidance page on substantial amendments to a clinical trial if the UK leaves the EU with no deal
  • DHSC guidance on prescriptions issued in the EEA and Switzerland
  • No changes to UK right to work checks for EU citizens until 2021

Seminars

  • Fast-growth companies: their keys to success – Dublin, Wednesday 1 May 2019

Key Contacts