It’s time to transform from a content- to a data-centric operational model: the view from Amplexor’s Renato Rjavec

As 2022 wraps up, we asked those in the know about the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.

Here’s what Renato Rjavec, Director of Product Management at Amplexor Life Sciences, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

Beyond running their day-to-day operations, I believe Regulatory teams need to focus the majority of their efforts on the transformation from a content- to a data-centric operational model.
DADI is already providing an imminent touchpoint with regard to IDMP requirements and, if companies aren’t already at the beginning of this pivotal journey, or don’t at least have a sound plan for it, they won’t be on the right path to having efficient and scalable Regulatory operations in the years to come.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

Regardless of its limited initial implementation scope, DADI will evolve and, in due course, present additional data submission requirements from the industry. The most impactful milestone on the IDMP journey will be the transition from XEVPRM to the FHIR data submission format.

Although there are high chances for further delays – and nothing will happen overnight – such a transition will take time to implement. It’s essential then that Regulatory has a sound strategy and long-term plans to establish a solid foundation for the upcoming requirements, before these are implemented.

On the other hand, the tactical aspects of the implementation needs to remain agile so that they’re able to adjust to any uncertainties related to scope, timelines, and technical details.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

Those who may still be addressing emerging data submission requirements with a patchwork of temporary or partial solutions will find they face more and more challenges over time. Ensuring that their end-to-end RIM platform is ready for the data-centric future, while supporting the IDMP requirements, should be at the top of their priority list.
We recommend companies take into account the following critical factors when selecting a suitable platform:
• A data-centric design at the core of the platform, so that data can become a key asset for the organization;
• Data quality controlled at several levels, to ensure compliance and business efficiency;
• A user experience that’s based on built-in business rules and automations, enabling a user-friendly efficiency with each use case;
• Connectivity providing for seamless internal and external process and data flows; and
• Flexibility, making it possible to adapt readily to evolving regulatory and business requirements.

About the author

Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and
Submission Management.