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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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Ask Fitis, the Bear: Real Crooks Sign Their Malware

Krebs on Security

This post is a deep dive on “ Megatraffer ,” a veteran Russian hacker who has practically cornered the underground market for malware focused code-signing certificates since 2015. One of Megatraffer’s ads on an English-language cybercrime forum. ” Fitis’s Livejournal account. Image: Archive.org.

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Why IDMP compliance requires adaptive data governance

Collibra

Pharmaceutical, biotech and medical devices firms, among others, must comply with a plethora of regulations. EMA expects pharmaceuticals to submit product data in IDMP format with a mandatory effective date of Q1 2023. The regulatory landscape in life sciences is both complex and in flux.

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

Krebs on Security

.” KrebsOnSecurity also reported that Shelest’s email address was used circa 2010 by an affiliate of Spamit , a Russian-language organization that paid people to aggressively promote websites hawking male enhancement drugs and generic pharmaceuticals. Shelest denied ever being associated with Spamit. government.

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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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New Gimmal Partnership with NNIT Brings Life Science Customers an Accelerated, GxP-Capable Information Governance Solution

Gimmal

The new collaboration is off to a great start with its first successfully completed joint solution delivery for a top, leading global pharmaceutical company. NNIT has deep life sciences expertise, specifically within the compliance and validation arena, so we know how important it is to document and keep immaculate records.

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What’s new in OpenText Documentum for Life Sciences Cloud Edition (CE) 20.2

OpenText Information Management

Pharmaceutical and Life Sciences companies are in the public spotlight as they pursue advanced therapies and vaccines to combat the coronavirus pandemic. Productivity, flexibility and governance capabilities are more critical than ever for speeding these life-saving products to market.