IAM's Role in the Pharmaceutical Sector

Data Breach Today

Sandy Dalal of Allergan on Achieving Security Stability Mergers and acquisitions, along with cloud adoption, are rapidly changing the pharmaceutical industry.

Pharmaceutical companies exploited by phishing scam targeting job seekers

IT Governance

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.

Life Sciences at Enterprise World 2019

OpenText Information Management

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.

Pharmaceutical Company to Plead Guilty and Settle Drug Marketing Charges

Hunton Privacy

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.

Reimagining patient centricity and healthcare practitioner engagement for 2020

DXC Technology

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.

Sales 52

ISO identification of medicinal products (IDMP)

OpenText Information Management

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.

Blog 70

Introducing OpenText Life Sciences Express – it’s simple

OpenText Information Management

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.

Making Internal Audits More Relevant

Data Breach Today

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?

The hidden threats facing your intellectual property

IT Governance

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

Business Process Modeling Use Cases and Definition

erwin

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.

Former Physician Convicted of Criminal HIPAA Violation

Data Breach Today

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

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

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

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

Cloud 47

Who Is Responsible For The Compliance Of Cloud Systems?

Perficient Data & Analytics

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

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.

IT 41

Key Takeaways About Compliant IT Systems In The Cloud

Perficient Data & Analytics

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!

Cloud 40

How To Qualify Cloud Vendors

Perficient Data & Analytics

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

Cloud 40

Ensuring quality control and compliance

OpenText Information Management

How does an emerging pharmaceutical company manage rapid growth, protect its intellectual property (IP) and comply with strict regulatory requirements?

How To Use Contracts For Regulatory Compliance Of Cloud Systems

Perficient Data & Analytics

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.

Introducing Box GxP Validation: Compliance for an Agile Cloud

Box

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

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

Transforming pharma’s customer value chain with digital technologies

DXC Technology

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

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

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

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

More Attacks against Computer Automatic Update Systems

Schneier on Security

Also, our experts identified three additional victims: another video gaming company, a conglomerate holding company and a pharmaceutical company, all in South Korea.

My Health Record: big pharma can apply to access data

The Guardian Data Protection

‘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.

Is Co-Authoring the Right Prescription for You?

AIIM

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.

Malvertising campaign exploits recently disclosed WordPress Plugin flaws

Security Affairs

“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.”

NEW TECH: How Semperis came to close a huge gap in Active Directory disaster preparedness

The Last Watchdog

pharmaceutical giant Merck; the crippling of its AD tool resulted in suffering drug shortages and losing hundreds of millions of dollars ( latest estimation is 870 million ). In today’s complex IT environments, a million things can go wrong, though only a few systems touch everything.

This is the old ChiefTech blog.: Janssen-Cilag Wiki Case Study

ChiefTech

Tuesday, 21 August 2007 Janssen-Cilag Wiki Case Study Here is a great Aussie wiki case study shared by Nathan Wallace from Janssen-Cilag , a pharmaceutical subsidiary of Johnson & Johnson. This is the old ChiefTech blog. Nice of you to drop in and visit.

Chronicle experts spotted a Linux variant of the Winnti backdoor

Security Affairs

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

Industry-specific regulations in areas like healthcare, pharmaceuticals and financial services have been in place for some time.

German firms BASF, Siemens, Henkel hit by cyber attacks

Security Affairs

Recently Chronicle researchers while investigating the cyber attack that hit the Bayer pharmaceutical company in April spotted a Linux variant of the Winnti backdoor.

Episode 158: How NotPetya has Insurers grappling with Systemic Cyber Risk

The Security Ledger

And, for companies impacted, it was impressively damaging: halting production lines and operations at global corporations in shipping, pharmaceuticals and manufacturing. We talk to Bruce McDonnell of the East West Institute about how insurers are responding.

Why real-world evidence is a game changer for life sciences in the age of value-based care

DXC Technology

What that demands for pharmaceutical companies is better insight into the fair market value their products bring, or potentially will bring, to maximize all the benefits of those products. by Jared Kimble Value-based care is quickly becoming integral to the life sciences industry as the entire healthcare sector undergoes increased convergence.

ICO Announces First Data Protection Sandbox Participants

Hunton Privacy

The projects selected by the ICO include proposals by the Greater London Authority, Heathrow Airport Holding Limited (which is looking at the use of facial recognition technology to streamline passenger journeys), NHS Digital and the Ministry of Housing, Communities and Local Government, as well as private organizations such as FutureFlow, Novartis Pharmaceuticals UK Limited and Trust Elevate.

Q&A: The drivers behind the stark rise — and security implications — of ‘memory attacks’

The Last Watchdog

Merck had one of its pharmaceuticals delayed, which led to a global shortage. A distinctive class of hacking is rising to the fore and is being leveraged by threat actors to carry out deep, highly resilient intrusions of well-defended company networks. Related: Memory hacking becomes a go-to tactic These attacks are referred to in the security community as “fileless attacks” or “memory attacks.”

BEST PRACTICES: Rising complexities of provisioning identities has pushed ‘IGA’ to the fore

The Last Watchdog

Its customer base is comprised of eight of the top 15 banks, four of the top six healthcare insurance and managed care providers, nine of the top 15 property and casualty insurance providers, five of the top 13 pharmaceutical companies, and 11 of the largest 15 federal agencies. Identity governance and administration, or IGA , has suddenly become a front-burner matter at many enterprises. Related: Identity governance issues in the age of digital transformation.