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Regulatory
BioTalk Editorial Team
BioTalk Editorial Team
COVID-19: Our series of regulatory legislation trackers for the Life Sciences & Healthcare industry
COVID-19 presents an unprecedented challenge to the global life sciences industry.  Members of our International Life Sciences & Healthcare team, lawyers who have a wealth of hands-on experience and strong relationships with regulatory bodies, have worked together to provide an update in the form of a Q&A for each of the countries we are located.  This update aims to provide guidance on the responses of EU and Asia-Pac regulators in the areas of clinical trials, medical devices,...
May 7, 2020
1 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...
May 22, 2023
3 min read
regulation of medical devices General
Sophie Vo
Sophie Vo
Proposed updates to the regulation of medical devi...
While it might be challenging for manufacturers of medical devices...
May 10, 2023
3 min read
Spring Budget Biotech
Phillipus Putter
Phillipus Putter
What the replication crisis means for AI and drug ...
Back in May 2016, the scientific publication Nature surveyed...
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
Healthcare
Emma Stok
Emma Stok
 Hester Borgers
Hester Borgers
The Netherlands: Tolerance policy on online prescribing of medication now embodied in new policy rule
On 11 April 2023, the Dutch Ministry of Health, Welfare and Sport announced a new policy rule for the...
April 24, 2023
3 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
Spring Budget Regulatory
Sally Shorthose
Sally Shorthose
 Nick Gorensweigh
Nick Gorensweigh
 Sophie Vo
Sophie Vo
UK Spring Budget – Streamlining regulation and plans for growth in life sciences
As part of last week’s Spring Budget, the UK Chancellor, Jeremy Hunt, announced increased funding of...
March 20, 2023
4 min read
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