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Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier

Data Matters

On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. Background. Judgment and implications.

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Mozilla Drops Onerep After CEO Admits to Running People-Search Networks

Krebs on Security

“Though customer data was never at risk, the outside financial interests and activities of Onerep’s CEO do not align with our values,” Mozilla wrote. In a statement released today, a spokesperson for Mozilla said it was moving away from Onerep as a service provider in its Monitor Plus product.

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National Safety Council data leak: Credentials of NASA, Tesla, DoJ, Verizon, and 2K others leaked by workplace safety organization

Security Affairs

The vulnerability posed a risk not only to NSC systems but also to the companies using NSC services. Also, the credentials could have been used to gain initial access into corporate networks to deploy ransomware, steal or sabotage internal documents, or gain access to user data.

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Alleged docs relating to Covid-19 vaccine leaked in darkweb

Security Affairs

Experts from threat intelligence firm Cyble have found documents relating to Covid-19 vaccine of European Medicines Agency in the Darkweb. Security experts from threat intelligence firm Cyble have found several documents relating to the Covid-19 vaccine allegedly stolen from the European Medicines Agency (EMA) leaked in the Darkweb.

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The Value of Data Governance and How to Quantify It

erwin

For example, one global pharmaceutical giant reduced cost by 70 percent and generated 95 percent of production code with “zero touch.” Risk Management and Regulatory Compliance. Risk management, specifically around regulatory compliance, is an important use case to demonstrate the true value of data governance.

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Ransomware accounts for 54% of cyber threats in the health sector

Security Affairs

The document also analyzes the impact of the cyber attacks on the sector and provides details about the most targeted entities and affected assets. 42% of incidents reported targeted hospitals, while health authorities, bodies and agencies accounted for 14%, and the pharmaceutical industry for 9%.

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New Cybersecurity Directives (NIS2 and CER) Enter into Force

Hunton Privacy

However, the concept of an “essential entity” is much broader and will also capture many organizations that have, to-date, not been subject to the NIS regime—for example, pharmaceutical companies and operators of hydrogen production, storage and transmission. Reinforced obligations.