Life Sciences annual round-up: reviewing 2017 and previewing 2018 [Archived]
Life Sciences annual round-up: reviewing 2017 and previewing 2018 [Archived]

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • Life Sciences annual round-up: reviewing 2017 and previewing 2018 [Archived]
  • Reviewing 2017
  • Brexit
  • Research and development
  • Intellectual Property
  • Manufacture, marketing and sale
  • Other developments of interest
  • Previewing 2018
  • Data protection and confidential information
  • Manufacture, marketing and sale
  • more

This year’s annual round-up reviews some of the most significant developments of 2017 and previews what is on the horizon for 2018. This includes the decision on the relocation of the European Medicines Agency; the delay in the implementation of the new Clinical Trials Regulation; preparations for the new Medical Devices Regulations; the Life Sciences Sector Deal; as well as the forthcoming application of the General Data Protection Regulation and introduction of the Accelerated Access Pathway. Also included are updates on LexisNexis®’s content, including news of exciting developments from the past year and what is coming up in the next 12 months.

Reviewing 2017

Brexit

What happened?

On 20 November 2017 Amsterdam was chosen as the new home of the European Medicines Agency (EMA) following Brexit.

What are the practical implications?

There are several practical implications of the relocation of the European medicines regulator from London to Amsterdam. Firstly, EMA’s operations will be affected as the EMA looks to free up staff to focus on preparing for the relocation and loses staff that do not wish to relocate. To deal with this, the EMA has drawn up a business continuity plan which outlines three levels of priority and categorises and prioritises tasks according to their impact on public health. Activities falling under Category 3, which include, among others, the

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