AMPLEXOR Webinar on demand desktop-monitor.png

Regulatory Master Data Management - Best Practices to get it right

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

You will walk away with an understanding of:

✔ 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?

Integral/unified end-to-end assessment: from product data to registered position and back

Watch now for free

Meet the speaker

Romuald Braun
Romuald Braun is Vice President Strategy, Life Sciences at AMPLEXOR. Since 1992, Romuald has worked in roles related to compliance, document management and content management in the life sciences industry. Romuald has taken roles on the client side and in consulting, in delivery, in sales, in project roles and in line responsibility. He has also worked in client server and in cloud environments, in both Europe and in the US. Romuald holds a Master’s degree in Drug Regulatory Affairs, in addition to his Engineer diploma in Data Technology.