19 December 2017

Whether the driver is specific to regulatory targets such as IDMP compliance, or better visibility of product information across operations, improved data management will only deliver value if companies harness it strategically – for accelerating product labelling, and easing the management of local translations, for example.

Next-generation master data management (MDM 2.0) is about taking product lifecycle data and using it to operational and competitive advantages, through targeted automation – resulting in a tangible impact on business performance.

Amplexor invites you to join us and explore what’s possible - and what’s involved.

  • The value chain in Integral regulatory information management, harnessing and moving beyond product data (XEVMPD/IDMP) to enable:
    • Structured and more automated content / translations
    • Content creation and document population
    • One-click published output
  • The power of Integral RIM to enable something greater:
    • Combining product data with regulatory intelligence, to create actionable insight
    • Harnessing artificial intelligence to increase content and submission quality
    • Automated creation of content and structures
    • Headquarters & affiliates alignment and parity


Discover how to create a blueprint for MDM 2.0/integral RIM and:

  • Understand the vision, mapping out what’s possible
  • Focus on the product, rather than data or content
  • Innovate for the future rather than replicating the past
  • Turn regulatory compliance into business value

The session will also feature short, practical demos, showing you how to:

  • Populate a structured document with approved master data components:
    • Dragging & dropping content fragments in product and application context
    • Editing a structured document
    • Extrapolating master data changes
  • Manage impact assessment & automated handling of content variations:
    • Creating a regulatory program
    • Discussing the resulting matrix
    • Discerning regulatory activities
  • Automate submission creation via structured authoring:
    • Discussing the comprehensive structure
    • Creating individual submissions
    • One-click publishing

All attendees will come away with a clearer vision for how to make product data initiatives work harder for the business - by adopting an MDM 2.0 strategy that uses digital data assets to enable confident, efficient content process automation and accelerate speed-to-market.


Romuald Braun, Vice President, Strategy - Amplexor Life Sciences

Romuald’s 25-year career to date has been spent across roles related to Compliance, Document Management, Content Management in the Life Sciences industry – both on the client side and in consulting, spanning delivery, sales, project and line manager roles. His experiences bridges on-premise and cloud environments, in Europe and in US.

He holds a Master of Drug Regulatory Affairs degree in addition to an Engineering diploma in Data Technology. He is a frequent speaker on topics relating to content management adoption in life sciences.

Siniša Belina, Senior Life Sciences Consultant - Amplexor Life Sciences

Siniša started his professional career at Pliva (now member of the TEVA Group), where in addition to his responsibilities in manufacturing, he was involved in a successful EDMS implementation project.

Siniša later joined KRKA’s Regulatory Affairs Department, and finally moved to Amplexor, where he applies his detailed knowledge of pharmaceutical documentation and processes to areas of business process analysis and EDMS optimisation.