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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.

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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. WHO IS MEGATRAFFER? My fingerprints change beyond recognition every few days.

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The Belgian Data Protection Authority Publishes Recommendation Concerning Data Processing for Direct Marketing Purposes

HL Chronicle of Data Protection

On January 17, The Belgian Data Protection Authority (DPA) published Recommendation no 01/2020 providing Guidance on direct marketing. The Recommendation provides a methodology on how to comply with the General Data Protection Regulation (GDPR) when conducting direct marketing. Definition of Direct Marketing.

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Redefining clinical trials: Adopting AI for speed, volume and diversity

IBM Big Data Hub

For instance, the FDA released guidance in November 2020 titled, “Enhancing the diversity of clinical trial populations.” Ineffective outreach : Clinical trial marketing efforts sometimes miss the mark. The FDA’s 2020 guidance emphasized expanding eligibility criteria and reducing unnecessary exclusions.

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How to protect healthcare and life-sciences data from a cyber attack pandemic

Thales Cloud Protection & Licensing

According to analyst firm IDC , 93% of pharmaceutical companies and 72% of biotech companies already have business-critical applications in the cloud, including product lifecycle management, analytics, revenue management, and much more. It is estimated the cost of US healthcare ransomware attacks alone at $21 billion in 2020.

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Optimizing clinical trial site performance: A focus on three AI capabilities

IBM Big Data Hub

Despite advancements in the pharmaceutical industry and biomedical research, delivering drugs to market is still a complex process with tremendous opportunity for improvement. The ability to seize these advantages is one way that pharmaceutical companies may be able to gain sizable competitive edge.

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Mobile Malware: Threats and Solutions

eSecurity Planet

McAfee recently published a report stating that mobile malware infections in the fourth quarter of 2020 surpassed 40 million after steadily climbing earlier in the year. Check Point published mobile security research showing that 46% of respondents experienced employees downloading at least one malicious app during 2020. ransomware?