Getting to the Centre of RIM:

Technology-Driven Regulatory Operations

Written by Hannah Riley and Aatif Kababi

Regulatory Operations has become an increasingly critical function for biopharmaceutical companies and health authorities as they face growing pressure to demonstrate improved efficacy and patient safety. This has placed pressure on Regulatory Operations to play a more strategic role. Traditionally, Regulatory Operations has been slow to adopt innovative solutions that could enhance performance, drive efficiencies and support new strategic capabilities. This is apparent when comparing Regulatory Operations to functions such as Clinical and Pharmacovigilance; functions that are embracing new technologies and intelligent solutions including Robotic Process Automation (RPA) and Natural Language Processing (NLP). They have been quick to identify appropriate solutions to support their processes and recognise the benefits of technology in providing more accurate, timely and high quality data. In contrast, Regulatory Operations remains largely manual, encumbered by complex processes, outdated technology and disconnected systems.

Delays in modernizing Regulatory Operations are further impacted by the need to keep pace with a global regulatory landscape in flux. New regulations and standards such as Identification of Medicinal Products (IDMP), E2B R3 safety reporting, EU clinical trials regulations and recent changes in medical and diagnostic device regulations have placed greater pressure on regulatory functions to deliver more, at a higher quality, under greater scrutiny, all while on limited resources.

After decades of inertia, Regulatory Operations are now moving towards introducing new solutions to advance capabilities, in order to improve regulatory efficiency and navigate an increasingly complex regulatory environment. This not only supports improved decision making to gain faster marketing approval, but also informs a long-term global strategy.

Structural and Operational Challenges

Based on Kinapse’s experience supporting biopharmaceutical companies across the regulatory spectrum, we have observed key constraints that place undue burden on Regulatory Operation function (See Fig 1.)

Demanding Regulatory Environment
  • Regulators are not only increasing their compliance oversight on existing legislation but also introducing new requirements to drive a more patient and data-centric approach

Diversification of Regulatory Structures
  • Organisational complexity is preventing effective interaction and engagement across the global-local divide

  • Information flow between structures requires optimisation, placing further pressure on existing resources, processes and technology

  • Operational challenges often arise from disconnected information flow due to multiple disparate solutions, outdated technology and home-grown solutions

  • These are the vestigial legacy of organic growth in the regulatory function, which can inhibit collaboration, data centralisation, and operational effectivity

Document & Data Management Issues
  • Difficulties in locating and identifying documents combined with version control issues and inconsistent formats collectively hinder the regulatory submission process and can have a negative impact on submission quality

Fig 1. 4 D’s of Reg Ops: Structural and Operational Challenges – a Kinapse model

Technology to the Rescue?

Innovative and well-implemented solutions are critical for regulatory functions to evolve and allow structural and operational challenges to be addressed. A well-considered approach to Regulatory Information Management (RIM) is of particular business benefit, especially one that encompasses efficient storage, retrieval and communication of regulatory information.

Solutions can be broadly classified as either ‘best-of-breed’ or ‘end-to-end’ with respect to their underlying deployment approach. ‘Best-of-breed’ solutions comprise discrete applications (including document management, publishing and submissions tracking) that specialise in either one or a collection of specific functions which can be deployed on an as needs basis. This approach can provide deep functional capability with respect to their workflows, however, the potential challenge of connecting capabilities into a coherent whole could lead to integration issues.

The ‘end-to-end’ deployment approach supports workflows across the entire regulatory spectrum from planning to publishing to tracking and archiving. A unified end user experience provides easier access to system functionality, while encouraging unified and standardised data across the regulatory enterprise. This strategy is not without concerns: significant financial investment is likely required with implementation taking longer, and therefore investment break-even occurring later. Moreover, though they may be more user friendly, depth of functionality may not be possible.

In both deployment approaches, companies will also need to consider data migration, validation, training, and change management activities; in the case of an end-to-end approach, this is likely to be significantly greater.

Taking a Holistic Approach

Though technology is beneficial for enhanced control of information and supports global operational efficiency for organisations, on its own it is not the panacea for all the ills of regulatory operations. In lacking robust processes and high-quality data, the potential benefits f technology investment will never materialise. An integrated approach encompassing processes, systems, data and RIM strategy is critical.

For an impactful RIM strategy, companies must consider the following:

  • Processes should be well-defined and supported by advanced capabilities (such as automation)

  • Systems must be designed to support their processes and business operations

  • Data must be of the highest quality to complement defined processes and state-of-the-art technology

Organisations recognise the need to be agile in order to adapt to frequent changes across global markets. This is important not only for reasons of compliance, but to demonstrate to patients the industry’s commitment to product safety throughout the entire product lifecycle. Ultimately, technology combined with a RIM strategy can support an organisation’s readiness and preparedness for future regulatory changes. More crucially, a RIM strategy can help to simplify current operations around compliance procedures, as organisations continue to adapt to an increasingly complex and rigorous regulatory landscape.

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