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Posts with tag Life Sciences
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SOHO ALERT: A Comprehensive Guide to the Proposed Regulation on Substances of Human Origin – Preparation Authorisation under the SoHO Proposal
The SoHO proposal introduces the procedure for obtaining an authorisation for SoHO preparations by the introduction of an EU-wide procedure. SoHO preparations are defined as a particular type of SoHO that:
(a) has been subjected to one or more SoHO activities, including processing, in accordance with defined quality and safety parameters;
(b) meets a pre-defined specification; and
(c) is intended for application to a recipient for a specific clinical...
January 18, 2024
7 min read
The Legal 500: Pharmaceutical Advertising Country Comparative...
The latest edition of the Legal 500: Pharmaceutical Advertising...
December 18, 2023
1 min read
Decarbonising the life sciences sector: challenges...
In 2019, it was reported that if the global healthcare sector...
December 12, 2023
6 min read
Prescribing AI: Contrasting Approaches to AI in Drug...
According to a common quip in the U.S. they innovate on the technology...
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
Horizon Scanning 2023
EMEA and Asia-Pacific HR & Employment Law Horizon Scanning & Update for the Life Sciences sector
We...
August 11, 2023
1 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
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
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
What does the European Commission’s proposed reform of EU pharmaceutical legislation mean for Paediatric medicines?
This article is part of a series that covers the proposed reforms to EU pharmaceutical...
July 26, 2023
4 min read