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Hester Borgers
As an associate in our Intellectual Property Group in Amsterdam, I specialise in patent law and life sciences regulatory. I have experience in complex patent litigation, with a strong focus on the medical devices industry and pharmaceutical sector. Furthermore, I assist a broad range of life sciences clients with their regulatory matters, including litigation. My regulatory experience also includes advising with regard to all things digital health - from telemedicine to AI.
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HMA-EMA publish multi-annual AI workplan: further guidance on the use of AI in the medicines lifecycle
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG) published a multi-annual (2023-2028)...
January 16, 2024
4 min read
AI in healthcare: the World Health Organisation’s regulatory considerations
The World Health Organisation (WHO) has published regulatory considerations on artificial intelligence...
December 5, 2023
5 min read
Prescribing AI: Contrasting Approaches to AI in Drug Development across the Atlantic
According to a common quip in the U.S. they innovate on the technology front, and the Europeans innovate...
October 19, 2023
9 min read
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, 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
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
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
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
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
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