Life Sciences

Can IDMP Transform the Way Life Sciences Firms Make Business Decisions?

Written by Frits Stulp in Life Sciences on 17/04/18

IDMP is a life sciences hot topic - Frits Stulp, Managing Director at Iperion Life Sciences Consultancy explores how organizations can use data smarter and more effectively

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How the MDR Directive Will Impact Packaging and Labeling Requirements in Europe

Written by Collette Bowers Vahed in Life Sciences on 14/04/18

It’s no exaggeration to say that the European Medical Device Regulation (EU MDR) is one of the most impactful pieces of legislation to hit the industry in decades. It was established to ensure a robust, transparent, predictable and sustainable regulatory framework for medical devices in the EU, improving health and safety while supporting innovation.

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Regulatory Operational Efficiency: Is Current RIM Fit for Purpose?

Written by John Cogan in Life Sciences on 10/04/18

John Cogan, head of innovation at Kinapse, thinks otherwise – and he’s on a mission to inspire change.

New drives to boost efficiency and agility around regulatory operations are all well and good. But it is very hard to consider alternative delivery models for activities – for instance outsourcing of post-approval licence management - if existing processes are held together by chewing gum and string. 

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Less Is More – and other lessons from the regulatory frontline

Written by Andrew Marr in Life Sciences on 03/04/18

Following his recent retirement from life sciences regulatory consultancy, former consultant Andrew Marr reflects on 30+ years in the industry

A few months ago I hung up my hat after more than 30 years advising on processes around regulatory document management, submissions and data in life sciences, giving me cause to reflect on some milestone changes I have witnessed over that time.

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Forging a Path Towards an Enterprise-grade, Neural Machine Translation Solution - for Life Sciences and more

Written by Elvis Paćelat in Life Sciences on 28/03/18

AMPLEXOR places great focus on adapting to the changing needs of our customers. We endeavor to use the latest technologies that allow those customers to do things smarter, more efficiently and more effectively.

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Patient safety and labeling: taking the pain out of managing translations in life sciences

Written by Kathleen O’Brien in Life Sciences on 13/02/18

It’s hardly exaggerating to say that the consequences for mistranslation of labeling and packaging in life sciences are potentially catastrophic. Most importantly, there is a substantial risk of patient safety that could occur, where, for example, misinterpretations in dosing could mean a matter of life or death.

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The growing need for centralized content management

Written by Jason Arnsparger in Life Sciences on 19/12/17

Life sciences is a challenging sector to operate in. Competition is tough, and success requires a combination of business agility and control.

But although life sciences is subject to stringent and ever-changing regulation, it can have a tendency to manage content for international markets in an inefficient and error-prone way. 

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Master data management and ISO IDMP standards

Written by Romuald Braun in Life Sciences on 23/11/17

Life sciences firms are used to an on-going stream regulatory hurdles, and the upcoming ISO IDMP compliance is another to add to the list. But ISO IDMP is also a little different, and promotes the kind of structure and discipline needed if organisations want to really break new ground and take their businesses forward.

How can organisations use ISO IDMP to change the way they operate, and to transform their master data management?

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Glaswegian Hospitality Sets the Tone for A Successful ISPOR Glasgow Conference

Written by Dana Weiss in Life Sciences on 14/11/17

AMPLEXOR Life Sciences exhibited at the 20th Annual European Congress of ISPOR - The International Society for Pharmacoeconomic Research - in Glasgow, Scotland last week. The conference drew more than 4700 attendees from the health economics and outcomes research (HEOR) community with this year’s theme being “The Evolution of Value in Health Care”. Topics discussed included the evolution of Health Technology Assessments (HTAs), the use of Real-World Evidence (RWE) to Support Regulatory Approvals, and Reimbursement Systems Across Europe.
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Labelling and Data Management: it’s all about the bigger picture

Written by Romuald Braun in Life Sciences on 20/09/17

For some firms in life sciences, product labelling is treated as a distinct, manually-driven process. This is a legacy of an era when technology was trusted and reliable than it is now, and it’s also a major error, as it can leave an organisation vulnerable to risk, such as costly product recalls, and inefficiency.

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