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IDMP: A Big Data Challenge for European Pharma

Written by Andrew Marr in Life Sciences on 23/05/17


At this year’s AMPLEXOR “Be The Expert 2017” event, Pharm Exec spoke to Andrew Marr about the implications of the EU’s new IDMP (Identification of Medicinal Products) regulations for the pharmaceutical industry.

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Life sciences set for the next stage of a technological revolution

Written by Sonja Vlašič in Life Sciences on 23/05/17


AMPLEXOR recently staged its 19TH annual life sciences conference, BE THE EXPERT 2017. Across three days of debate, discussion and presentations in Budapest, delegates learned more about some of the issues facing the life sciences industry in 2017 and also about some of the technological solutions that are available to address these issues. Elvis Paćelat, Vice President, Life Sciences, AMPLEXOR, gives an overview of what was discussed and where he feels the industry is heading.

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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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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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