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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
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
Windsor General
Pieter Erasmus
Pieter Erasmus
 Alex Kanellopoulos
Alex Kanellopoulos
The Windsor Framework: One Step Closer to a Single UK market
Following the coming into force of the Windsor Agreement on 25 March 2023, we take a look at what this...
April 3, 2023
5 min read
Clinical Trials General
Josh Price
Josh Price
UK Clinical Trials Changes – a Leg Up or a Step Down?
The government recently consulted on proposals intended to improve the UK’s clinical trials legislation...
April 3, 2023
2 min read
NIS2 Directive and the CER Directive General
Deirdre Kilroy
Deirdre Kilroy
 Georgina Parkinson
Georgina Parkinson
The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector
The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased...
February 17, 2023
9 min read
General
Sally Shorthose
Sally Shorthose
Guide to EU and UK Pharmaceutical Regulatory Law 2023
Eighth Edition, Edited by Sally Shorthose The Guide to EU and UK Pharmaceutical Regulatory...
January 31, 2023
3 min read
standards on health data General
Nour Saab
Nour Saab
 Alexandre Vuchot
Alexandre Vuchot
 Johanna Harelimana
Johanna Harelimana
Publication of CNIL standards on health data processing implemented in the context of early access and compassionate use authorisations
The French data protection authority (Commission Nationale de l'Informatique et des Libertés...
January 16, 2023
2 min read
medicinal products General
Heidi Hurdle
Heidi Hurdle
Rebranding generics as branded medicines – CJEU issues new guidance
The CJEU has provided welcome new guidance on when parallel importers can rebrand generic medicines with...
December 9, 2022
5 min read
parallel traders General
Guillaume de Villegas
Guillaume de Villegas
 Silke Fiers
Silke Fiers
To repackage or not? Latest CJEU rulings provide guidance for parallel traders of medicines
Repackaging of medicine is a hotly debated issue between pharmaceutical companies and parallel traders....
November 22, 2022
8 min read
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