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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
HMA-EMA publish multi-annual AI workplan: further guidance...
In December 2023, the joint HMA-EMA Big Data Steering Group (BDSG)...
January 16, 2024
4 min read
SOHO ALERT: A Comprehensive Guide to the Proposed Regulation...
Legislative process
On July 19, 2022, the European Commission...
January 10, 2024
6 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 and progress
In 2019, it was reported that if the global healthcare sector were a country, it would be the fifth largest...
December 12, 2023
6 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
Circular economy: what impact for healthcare players?
Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment...
September 28, 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
A Guide to the UPC and the UP
The opening of the Unified Patent Court (UPC) on 1 June 2023 may be the most significant development...
June 9, 2023
2 min read
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