Thinking outside of the box – seeing beyond the immediate Regulatory remit: the view from Iperion’s Remco Munnik

As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on 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 Remco Munnik, Associate Director at Iperion – a Deloitte business, had to say.

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

In my opinion, Regulatory has always been the spider in the web within a pharmaceutical company – collecting all of the relevant information for submission of the registration: Clinical, CMC, administrative data, etc. And then it faces the time crunch, to compile all documents into a valid eCTD by the submission deadline. Up to now this process has always been very document driven.

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?

The biggest challenge ahead is that data should become the leading source, and the content of documents must then align with that data. With EMA’s direction now toward agile development, pharmaceutical companies too must become agile – in terms of adapting their own processes and systems. The biggest challenge ahead is for companies to become more data-driven organizations, and to adapt complex processes and transform the content from large volumes of legacy documents into more dynamic, resuable data.

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?

I think it’s really important that companies reset their strategy now, moving away from document-oriented information delivery activity toward data-driven ways of working. An overall company strategy would benefit such initiatives significantly. In addition, it’s crucial that companies implement an agile way of working now, given the huge task ahead. This is about moving forward with small steps, making real progress overall and determining how things can work more efficiently.

Even if you can’t name the company, what is the best examples of advanced content/data management you have seen in life sciences recently, and what trajectory is that company now on? i.e. what benefits will it start to see, and how soon?

One company that we supported linked its RIMS (Regulatory) and ERP (resource planning) systems, allowing it to connect two worlds of data and enable reporting of key information. For instance, “Can a product from country X be sold in another region?”; “Which manufacturers are actually used?”; and “How long does it take to implement this type of variation in production, based on past experience?”

To identify use cases, structured data is key and should benefit companies’ daily activities. That is, data-based initiatives should be much broader than a “compliance” project, and be more strategic in outlook.

If you could change one aspect of most companies’ plans or thinking about data and document management for 2023, what would it be specifically? What one action should they take next to recalibrate?

This would be around the impact that the new web-based electronic application forms (eAFs) will have on Regulatory processes. Data is going to be tied in within the regulatory process of product assessment. Companies should get their data, system, governance and processes in place for this.

About the author

• Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
• Remco is also an active member of EMA ISO IDMP Task Force Organizations and Products; Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals. One of Iperion’s widely-acknowledged strengths is its deep networking with stakeholders across life sciences – including regulators, software vendors and customer groups.