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pharmaceutical legislation Pharmaceuticals
Anna Koster
Anna Koster
 Hester Borgers
Hester Borgers
 Sarah Faircliffe
Sarah Faircliffe
Proposed reform of the EU pharmaceutical legislation: New regime for orphan medicinal products under the proposed regulation
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 27, 2023
4 min read
Environmental Risk Healthcare
Emma Stok
Emma Stok
 Hester Borgers
Hester Borgers
 Sarah Faircliffe
Sarah Faircliffe
Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 23, 2023
3 min read
data protection Healthcare
Marc Martens
Marc Martens
 Sarah Faircliffe
Sarah Faircliffe
 Benedicte Mourisse
Benedicte Mourisse
European Commission proposes to change the rules on regulatory data protection for medicines
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
June 15, 2023
4 min read
General
Intellectual Property Team
A Guide to the UPC and the UP
The opening of the Unified Patent Court (UPC) on 1 June 2023 may be the most significant development...
June 9, 2023
2 min read
Healthcare
Sophie Vo
Sophie Vo
AI as a Medical Device
To add to all the chatter about AI, let's talk about AI as a medical device. Last...
May 22, 2023
3 min read
General
Sophie Vo
Sophie Vo
Proposed updates to the regulation of medical devices
While it might be challenging for manufacturers of medical devices to navigate the evolving regulations...
May 10, 2023
3 min read
Spring Budget Biotech
Phillipus Putter
Phillipus Putter
What the replication crisis means for AI and drug discovery
Back in May 2016, the scientific publication Nature surveyed over 1,500 researchers to find out how...
May 4, 2023
2 min read
Pharmaceuticals
Marc Martens
Marc Martens
 Lora Arifagic
Lora Arifagic
 Kevin Munungu
Kevin Munungu
Revamping the European pharmaceutical industry: A closer look at the EU’s proposed legislative framework
On 26 April 2023, the European Commission published the long-anticipated proposal for the revision of...
April 28, 2023
3 min read
clinical trials General
Phillipus Putter
Phillipus Putter
Single-arm clinical trials: EMA launches consultation
In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively...
April 26, 2023
2 min read
Biotech
Katrina Dang
Katrina Dang
 Johanna Harelimana
Johanna Harelimana
 Christian Lindenthal
Christian Lindenthal
 Hester Borgers
Hester Borgers
 Emma Stok
Emma Stok
 Pieter Erasmus
Pieter Erasmus
 Patrick Brown
Patrick Brown
 Enrique Rivas
Enrique Rivas
An international overview of the regulatory legislation concerning telemedicine
Telemedicine has been available to healthcare providers for several years. However, it was not until quite...
April 24, 2023
1 min read
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