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IAM's Role in the Pharmaceutical Sector
Data Breach Today
JULY 8, 2019
Sandy Dalal of Allergan on Achieving Security Stability Mergers and acquisitions, along with cloud adoption, are rapidly changing the pharmaceutical industry.
Healthcare Related Topics 
Pharmaceutical companies exploited by phishing scam targeting job seekers
IT Governance
MAY 16, 2019
Earlier this month, two major pharmaceutical giants issued warnings about phishing emails targeting job hunters. The post Pharmaceutical companies exploited by phishing scam targeting job seekers appeared first on IT Governance Blog.
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Top 5 Life Sciences predictions in 2020
OpenText Information Management
JANUARY 23, 2020
Industries Healthcare & Life Sciences Healthcare IoT Content management Interoperability the internet of things Life sciences EIM platform FDA pharmaceutical ISO IDMP Industry 4.0 With the patient taking center stage, digitization is gaining pace within Life Sciences.
Pharmaceutical Company to Plead Guilty and Settle Drug Marketing Charges
Hunton Privacy
MAY 19, 2016
Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid.
Life Sciences at Enterprise World 2019
OpenText Information Management
AUGUST 26, 2019
For the past three years, OpenText™ Enterprise World in July has been the destination of choice for business leaders and partners who have invested in Enterprise Information Management with OpenText.
What’s new in OpenText Documentum for Life Sciences Release 16 EP7
OpenText Information Management
NOVEMBER 12, 2019
Every pharmaceutical company wants to accelerate the drug development process – from discovery to commercial success – to deliver new treatments that improve patient outcomes.
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Reimagining patient centricity and healthcare practitioner engagement for 2020
DXC Technology
APRIL 30, 2019
Life Sciences analytics healthcare pharmaceuticalby Satish Pandelenghat and Manjunath Shanabag The relationship between the life sciences industry and healthcare practitioners has changed dramatically in recent years.
Tackling the ‘inconvenient truth’ of AI in healthcare
OpenText Information Management
NOVEMBER 28, 2019
AI & Analytics Industries Healthcare & Life Sciences AI AI in Healthcare biopharma Healthcare Life sciences pharmaceuticalThe market is growing fast for Healthcare Artifical Intelligence (AI), estimated to reach over $8 billion by 2026. During this year’s Intelligent Health conference, there was a great deal of talk about the potential of AI in healthcare, but also about its largest challenges: data integration and preparation.
Four Use Cases Proving the Benefits of Metadata-Driven Automation
erwin
FEBRUARY 7, 2019
Metadata-Driven Automation in the Pharmaceutical Industry. One global pharmaceutical giant headquartered in the United States experienced such issues until it adopted metadata-driven automation.
Making Internal Audits More Relevant
Data Breach Today
DECEMBER 13, 2018
Prasanna Bharatan, internal auditor at the pharmaceutical company Wockhardt, outlines the important steps to take Wockhardt's Prasanna Bharatan on Why Audits Often Are Not Meaningful How can improve internal audits be improved and made more meaningful?
ISO identification of medicinal products (IDMP)
OpenText Information Management
FEBRUARY 26, 2018
Enterprise Content Management Information Management EIM ISO IDMP Life sciences pharmaceuticalIn a previous blog I looked at some of the EU regulations that are disrupting the Life Sciences sector.
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Introducing OpenText Life Sciences Express – it’s simple
OpenText Information Management
MARCH 13, 2018
Simplicity. That’s what every Life Sciences professional working with regulated business processes needs today. That’s exactly what they’re getting with the intuitive user experience and efficient cloud-based access of our new OpenText™ Life Sciences Express. Here’s why simplicity is so important.
Business Process Modeling Use Cases and Definition
erwin
MARCH 28, 2019
This also extends to industry-specific other compliance mandates such as those in healthcare, pharmaceutical and the financial services industries. What is business process modeling (BPM)? A visual representation of what your business does and how it does it.
The hidden threats facing your intellectual property
IT Governance
SEPTEMBER 4, 2018
For life sciences and pharmaceutical companies, this includes data on the development and testing of new therapies and details of how therapies are manufactured. Cyber Resilience Healthcare Intellectual Property Life Sciences Pharmaceutical
Former Physician Convicted of Criminal HIPAA Violation
Data Breach Today
MAY 4, 2018
The case was tied to providing a pharmaceutical salesperson access to patients' medical records Case Involved Unauthorized Access to Patient Records A former Massachusetts gynecologist has been convicted in a rare case involving a criminal HIPAA violation.
With a focus on seamless sharing across domains, OpenText Documentum for Life Sciences 16.4 takes a giant leap forward
OpenText Information Management
JULY 3, 2018
When major acquisitions happen, market analysts, competitors, customers, and employees alike are watching closely to determine what’s next.
My Health Record 'identical' to failed UK scheme, privacy expert says
The Guardian Data Protection
JULY 21, 2018
Health Data protection Australia news Technology Privacy Pharmaceuticals industryCare.data was cancelled because drug and insurance companies were able to buy patient data Australia’s impending My Health Record system is “identical” to a failed system in England that was cancelled after it was found to be selling patient data to drug and insurance companies , a British privacy expert has said.
Maintaining Regulatory-Compliant Cloud Solutions
Perficient Data & Analytics
JUNE 1, 2018
Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology
Who Is Responsible For The Compliance Of Cloud Systems?
Perficient Data & Analytics
JUNE 21, 2018
Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyAny time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor.
Refresher: Which IT Systems Are Regulated
Perficient Data & Analytics
JUNE 7, 2018
Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyIf your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated.
Key Takeaways About Compliant IT Systems In The Cloud
Perficient Data & Analytics
JULY 19, 2018
Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyThis is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way!
How To Qualify Cloud Vendors
Perficient Data & Analytics
JUNE 28, 2018
Because the ultimate responsibility for regulatory compliance lies with you – the pharmaceutical or medical device company – you need to be much more proactive and critical. Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technology
Introducing Box GxP Validation: Compliance for an Agile Cloud
Box
JANUARY 18, 2018
Organizations in the life sciences, including pharmaceuticals, biotech and medical device companies, are rapidly transforming.
Using a 'Privacy by Design' Approach to GDPR Compliance
Data Breach Today
MARCH 2, 2018
To prepare for compliance with the EU's GDPR, which will be enforced beginning in May, organizations must adopt a "privacy by design" approach, says Subhajit Deb, CISO at Dr. Reddy's Laboratories, an India headquartered pharmaceutical company that does business in 11 countries
How To Use Contracts For Regulatory Compliance Of Cloud Systems
Perficient Data & Analytics
JULY 5, 2018
Cloud Data & Analytics Digital Transformation Integration & IT Modernization Life Sciences Operations Regulatory Compliance Strategy 21 CFR Part 11 clinical cloud compliance Data hosting IaaS medical device PaaS pharmaceutical Regulatory SaaS Software Systems technologyIn the previous post in this series, we discussed how to qualify cloud vendors.
Australian government secretly releasing sensitive medical records to police
The Guardian Data Protection
JANUARY 26, 2020
The Department of Human Services fields large volumes of requests for Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) data from state and federal policing agencies each year.
Ensuring quality control and compliance
OpenText Information Management
SEPTEMBER 3, 2019
How does an emerging pharmaceutical company manage rapid growth, protect its intellectual property (IP) and comply with strict regulatory requirements?
Transforming pharma’s customer value chain with digital technologies
DXC Technology
MARCH 14, 2019
by Satish Nair and Manjunath Shanabag Pharmaceutical companies struggle with a complex and, often, poorly managed partner, customer and distribution network. It’s not surprising, given the makeup of most large pharma companies. Large, often disconnected product portfolios are built through discovery — both internally and externally with academia and biotech partners — and global clinical […]. Analytics Business Processes Life Sciences
China gets ready to launch eCTD, as companies face a challenging learning curve
DXC Technology
MAY 16, 2019
by Winnie Yang and Leslie Wan China is gearing up for the implementation of electronic Common Technical Document (eCTD) submissions to accelerate the review and approval of new pharmaceuticals. A year after officially introducing the subject, the life sciences industry in this country is starting to see greater momentum toward implementation. Publication of official specifications […]. Life Sciences eCTD regulatory compliance regulatory content management
Regulatory Matters: EU regulatory change is coming fast in Life Sciences
OpenText Information Management
JANUARY 25, 2018
However, the next few years are about to see major new legislation in the EU that could result in major disruption to Life Sciences, Pharmaceutical and Healthcare companies – wherever they are. The Life Sciences sector is used to constant regulatory change.
Implementing a real-time catalog of enterprise data assets
Information Management Resources
MARCH 15, 2018
Beyond defining access privileges, effective data governance means that companies need to be able to document or label their data assets, much like the labels on pharmaceuticals. Data management Data visualization Data discovery
My Health Record: big pharma can apply to access data
The Guardian Data Protection
SEPTEMBER 17, 2018
‘Each application would be assessed on its own merits,’ senators told Pharmaceutical companies will be allowed to apply for data from the controversial My Health Record system, a Senate committee hearing has been told. Caroline Edwards, the deputy secretary of the Department of Health, told the committee third-party access arrangements would allow medical and public health researchers access to de-identified data. Continue reading.
Europol seized 30,506 Internet domain names for IP Infringement
Security Affairs
DECEMBER 2, 2019
“These included counterfeit pharmaceuticals and pirated movies , illegal television streaming, music, software, electronics, and other bogus products.”
More Attacks against Computer Automatic Update Systems
Schneier on Security
MAY 16, 2019
Also, our experts identified three additional victims: another video gaming company, a conglomerate holding company and a pharmaceutical company, all in South Korea.
Malvertising campaign exploits recently disclosed WordPress Plugin flaws
Security Affairs
JULY 24, 2019
“The Defiant Threat Intelligence team has identified a malvertising campaign which is causing victims’ sites to display unwanted popup ads and redirect visitors to malicious destinations, including tech support scams, malicious Android APKs, and sketchy pharmaceutical ads.”
Is Co-Authoring the Right Prescription for You?
AIIM
AUGUST 8, 2019
Pharmaceutical and Life Science are good examples of industries that are feeling the pain. Start by downloading the latest tip sheet from AIIM, “ Co-Authoring Tools Provide the Right Prescription for Pharmaceutical and Life Science Success.” Several months ago, I developed a nagging pain in my right shoulder. Nothing much at first, but over time, it got worse. Initially, I ignored the pain and hoped it would resolve itself. But it didn’t.
Benefits of Data Vault Automation
erwin
SEPTEMBER 26, 2019
Let’s take a look at a large global pharmaceutical company that switched to Data Vault automation with staggering results. Like many pharmaceutical companies, it manages a massive data warehouse combining clinical trial, supply chain and other mission-critical data.
NHS data is a goldmine. It must be saved from big tech | James Meadway
The Guardian Data Protection
DECEMBER 9, 2019
Over the weekend, it was revealed that US pharmaceutical companies have already been sold data relating to millions of NHS patients and that Amazon, incredibly, has been given free access to NHS data Hidden away in the secret US-UK trade papers, leaked and revealed by Labour in November, is perhaps the biggest single threat to public data yet seen. Health datasets play a vital role in medical research.
Chronicle experts spotted a Linux variant of the Winnti backdoor
Security Affairs
MAY 20, 2019
Chronicle researchers while investigating the cyber attack that hit the Bayer pharmaceutical company in April. “In April 2019, reports emerged of an intrusion involving Winnti malware at a German Pharmaceutical company.”
The Importance of EA/BP for Mergers and Acquisitions
erwin
JUNE 21, 2019
Industry-specific regulations in areas like healthcare, pharmaceuticals and financial services have been in place for some time.
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