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The Year Ahead for Life Sciences Regulatory

Amplexor asked some of its closest partners for their views on the most important developments in Life Sciences regulatory operations in 2022, and for their predictions for 2023. Renato Rjavec of Amplexor Life Sciences shares their input.

Of the most prominent issues facing Regulatory functions, Steve Gens sensed renewed urgency around improving global ways of working, particularly around reducing the time for market approvals. Gens & Associates, which has been tracking RIM-related improvement activity closely, has observed increased application of modern technology and digitisation focused on improved ways of working and process enhancement (change control, label management, regulatory intelligence) at an end-to-end level.

There is general agreement now that the shift away from inconsistent manual, document-oriented processes towards agreed use of standards-based data will be pivotal to transforming key processes. Remco Munnik noted that, up to now, 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 – then compiling a valid eCTD by the submission deadline. In future, all of this will be data driven, he said – requiring a different approach to managing everything and ensuring its quality. Kelly Hnat observed that the current advance toward structured data and new submission paradigms would have benefits for Regulatory, and across the enterprise, as the value of clear, accurate and complete data representations of registered medicinal products is tapped.

Resourcing to Meet Condensed Timeframes

The potential for transformed processes may be considerable, but the industry faces ongoing challenges in getting to where it would ideally like to be. Tris Nockles highlighted the challenges for organisations in assembling the right resources to meet increasingly condensed timeframes for submissions.

“Finding people with the right skills to work in Regulatory, which has been problematic historically, seems to have become a more difficult and lengthy pursuit in recent years,” she said, noting that it can take 6–12 months to onboard mid-level and senior staff these days. “On top of that, technology is under-delivering in many cases,” she added. “It’s not uncommon for companies to augment their RIM capabilities with more friendly technologies to capture and feed data in, or look to flexible resourcing to enter data on behalf of their Regulatory staff.”

With the twin challenge of speed of delivery in a highly competitive job market, Tris said, companies will need to consider new and innovative ways of filling the staffing void, whether through flexible resourcing (outsourcing/offshoring) and technology and automation to enable routine operational work, or adjusted talent strategies that value technology-savvy newcomers in the workforce.