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Regulatory transformation: cloud reality check

Written by Siniša Belina in Life Sciences on 19/10/16


An industry debate at AMPLEXOR’s annual user conference in June examined the role of cloud services in driving the next generation of regulatory information management in life sciences, and I want to share with you the main points of the discussion.

The need for regulatory information management (RIM) transformation is driving new interest in cloud services, particularly access to the latest applications via Software as a Service (SaaS) delivery models. But there are different approaches to the cloud, and data sensitivities to consider, so it is rarely a straightforward decision.

It was in this context that AMPLEXOR recently hosted a major industry panel debate, keen to sort the fact from the fiction and establish some best-practice approaches to cloud-based service use in life sciences. The discussion, chaired by Steve Scribner of consultancy The Scribner Group, brought together heavyweight regulatory experts and consultants from across the sector: Romuald Braun of uanotau; Peter Brandstetter of IBM’s GBS Life Sciences team; Torben Thorhauge of NNIT; and Steve Gens of Gens Associates. The audience, made up of AMPLEXOR customers, also participated in the debate.

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3 Reasons You Can’t Miss This Year’s Momentum Europe

Written by Chris McLaughlin in Life Sciences on 06/10/16


It seems hard to believe, but October 31 is just a little more than a month away. Our team is busy putting the finishing touches on Momentum Europe and we are preparing to welcome both business and IT decision-makers from across a number of different industries and from around the globe, including Europe, the Middle East, Africa, Asia and beyond.

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IDMP and the Requirement for Substance Information

Written by Steve Scribner in Life Sciences on 03/10/16


IDMP is an important concept and pending requirement for all Pharma. There have been many white papers, webinars and conference talks addressing it. It will surely require a responsive and collaborative organization to discover and collect the required information that will be demanded, even for Iteration 1. I hope that most of you have been busy analyzing the gap between your current capabilities and the future specifications.

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Update to IDMP Iteration 1

Written by Steve Scribner in Life Sciences on 23/06/16


The ISO IDMP Task Force met in April to compile recommended changes to the content of the information model. A revised draft version was scheduled for vote in the meeting on May 12. A revised timeline was also on schedule to be discussed. We will publish an update in the next blog.

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Regulatory transformation: the time is now

Written by Siniša Belina in Life Sciences on 21/06/16


Regulatory compliance has always been a double-edged sword for life sciences. It is an essential and central focus for investment because public safety, consumer confidence and sales depend on it. Yet this preoccupation with rules and risk can also be a barrier to innovation, because any deviation from the status quo increases the chance of non-compliance.

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Reinventing data management, with R&D at the centre

Written by Steve Scribner in Life Sciences on 30/03/16


Every business, and often every department, has its own way of doing things. In the life sciences industry this is true of the way companies and individual business functions record and manage information about drugs, making it difficult to gain a clear line of sight across a product’s lifecycle and its performance in the market. This has implications for the business as well as public safety.

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Agility

Written by Steve Scribner in Life Sciences on 25/01/16


Agility has become the magic word symbolizing Nirvana. To be ‘agile’ is a capability or state that everyone in business wants to achieve. Companies struggle to get their minds and their hands around it. They feel that if they cannot achieve ‘agility’, then they cannot successfully compete in our fast-moving market.

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Managing Change - part 3 - Getting Ready for IDMP

Written by Steve Scribner in Life Sciences on 08/12/15


This blog is the third part of a series on preparing for introducing a major new system into the Regulated Product process for Life Science sponsors. This is appropriate for all Pharmaceutical and Medical Device-related companies. The specific topic is Getting Ready for IDMP starting with an understanding of your internal Information Architecture.

My intention with this edition is to propose a pragmatic approach to prepare you for the coming changes. We spoke in the last edition about understanding where you are now through developing an Information Architecture to describe your current state. I will now focus on what to do next.

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Progress Report on the DIA Reference Models

Written by Steve Scribner in Life Sciences on 08/12/15


The best way I can put it is that we, the Life Science Industry, took on a quest; an adventure, with a purpose clearly in sight. Stemming from a roundtable dialog held at a DIA conference on Electronic Document Management (EDM) in 2006, the industry was struggling with a pressing need to implement document (or content) management systems to help manage the highly valuable intellectual property that the industry is well known for. There had been a sizable number of very large companies that had implemented custom solutions carefully configured to meet the interests of each company but this approach was not yielding a more universal solution. There were a few frustrating factors:

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Managing Change - part 2 - Preparing for Major New Systems (e.g. IDMP)

Written by Steve Scribner in Life Sciences on 08/12/15


The most significant change that Life Science companies are facing today is the preparation for Identification of Medicinal Products (IDMP). This new regulatory requirement will truly bring together the structured and unstructured information within the organization and be able to dynamically prepare submissions to regulatory agencies. There are plenty of presentations available that describe the new ISO standards and the overview of required data. Not all data groups will be required at the beginning and submissions will have different timelines based on each regulatory agency. The implementation guidelines for the EMA and FDA have not been released yet (expected at end 2015) but the real challenge will be to address your internal Information Architecture and supporting production systems. These will need analysis, alignment and harmonization. It will not be necessary to do all the planning before your can start with implementation, but to some extent a gap analysis will be essential so you will know where to begin.

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