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Posts with tag Clinical Trials

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Spanish courts say “no” to the evergreening on data exclusivity of medicines.
Three recent judgments handed down by the Central Administrative Courts Nos. 4, 10 and 2 on 30 March, 14 May 2021 and 27 May 2021 (ordinary proceedings Nos. 26/2019, 27/2019 and 26/2019), respectively, shed light on the data exclusivity and, in particular, on the consequences of the use and re-use of data from clinical trials or pre-clinical studies within the framework of a marketing authorisation dossier for a medicinal product (hereinafter, "MA"). These judgments establish that the use of data...
June 14, 2021
8 min read
Singapore Gets Vaccinated! Introduction of the Pandemic...
As part of a slew of measures to mitigate the effect...
March 25, 2021
6 min read
COVID-19: The NIPN’s Regulatory and Data Protection...
On the tails of the EMA’s Guidance on the Management of Clinical...
April 27, 2020
8 min read
COVID-19: ANSM guidance on Data Protection requirements...
ANSM guidance underlines that adjustments to on-going clinical...
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
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