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Posts with tag Clinical Trials
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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. To view our first article and the whole series, please click here.
One of the key changes to the legislation – and the focus of much debate - is a review of the rules regarding regulatory data protection.
In the draft text of the new Directive, the Commission devotes an entire chapter to regulatory data and market protection. The proposed new framework is more complicated than...
June 15, 2023
4 min read
Single-arm clinical trials: EMA launches consultat...
In contrast to randomised controlled trials (RCTs), single-arm...
April 26, 2023
2 min read
Publication of the English version of the new French...
The French legislator recently updated the French clinical...
October 10, 2022
2 min read
Spanish courts say “no” to the evergreening on data...
Three recent judgments handed down by the Central Administrative...
June 14, 2021
8 min read
Singapore Gets Vaccinated! Introduction of the Pandemic Special Access Route (PSAR) for COVID-19 vaccines, therapeutic products and medical devices
As part of a slew of measures to mitigate the effect of the COVID-19 pandemic in Singapore,...
March 25, 2021
6 min read
COVID-19: The NIPN’s Regulatory and Data Protection Guidance on adjustments in clinical trials
On the tails of the EMA’s Guidance on the Management of Clinical Trials during the COVID-19 pandemic,...
April 27, 2020
8 min read
COVID-19: ANSM guidance on Data Protection requirements for on-going trials
ANSM guidance underlines that adjustments to on-going clinical trials in the context of Covid-19...
April 20, 2020
4 min read
Blockchain in the Life Sciences & Healthcare Sectors
Blockchain is perhaps best known as the technology on which Bitcoin and other digital cryptocurrencies...
February 25, 2020
13 min read