⌚ 14:00 GMT (10:00 am EDT)
⌚ 19:00 GMT (3:00 pm EDT)

New and evolving regulatory requirements, including the forthcoming ISO IDMP standards and new FDA CMC guidance,
are forcing Life Sciences companies to clean up their product data and the way they manage and structure it.

Companies are required to look beyond building greater master data sources and consider how they will exploit it – for instance, as a driver for greater process automation. So that if content used in regulatory submissions and other output is changed, the impact of those changes can be quickly calculated and managed in a logical, connected way. Regulatory Master Data Management is about combining regulatory master data with regulatory intelligence management to drive these kinds of process efficiencies, by enabling automation.

In this best practices-style webinar, AMPLEXOR’s Romuald Braun will explore and review the key challenges organizations face in addressing Regulatory MDM and strategies to overcome them.

Highlight webinar discussion points include:

  • Data models, data architectures, taxonomies and other “Onomies”
  • Product master data versus regulatory intelligence – where is the border?
  • Integrated versus unified architecture – costs of complexity or integral value?
  • Use case - from compliant to variation
  • Integral/unified end-to-end assessment: from product data to registered position and back

ABOUT THE SPEAKER


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.