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Regulatory

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regulate AI MedTech
Hester Borgers
Hester Borgers
 Christian Lindenthal
Christian Lindenthal
 Nils Loelfing
Nils Loelfing
EMA’s envisaged risk-based and human-centric approach to regulate AI
Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal...
September 14, 2023
6 min read
AI and the life sciences Medical Devices
Hester Borgers
Hester Borgers
 Christian Lindenthal
Christian Lindenthal
AI and the life sciences, navigating the complex legal landscape
Bird & Bird’s international life sciences and healthcare team is at the forefront of the legal...
August 10, 2023
5 min read
marketing authorisation Regulatory
Sophie Vo
Sophie Vo
 Sally Shorthose
Sally Shorthose
EU Commission’s proposed changes to marketing authorisation procedures
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
August 9, 2023
6 min read
medicinal products Pharmaceuticals
Lora Arifagic
Lora Arifagic
 Sarah Faircliffe
Sarah Faircliffe
Reforming the European pharmaceutical legislation: Shortages of medicinal products
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
August 7, 2023
5 min read
Cultivated meat Regulatory
Emma Stok
Emma Stok
 Sander Wagemakers
Sander Wagemakers
 Hester Borgers
Hester Borgers
 Nicolas Carbonnelle
Nicolas Carbonnelle
Code of practice introduced for holding cultivated meat tastings
Particularly in the Netherlands, developments in the field of cultivated meat have succeeded each other...
July 12, 2023
6 min read
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
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
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