In a recent BioSpace webinar, Michael King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions, discussed the critical role of agility in the evolving responsibilities of Quality Assurance and Regulatory Affairs (QARA) professionals.

As global and local regulatory requirements rapidly shift, QARA professionals face the immense challenge of staying compliant while managing increasingly complex and siloed systems. In fact, a new or changed regulation or reference document is reportedly published every 20 minutes. In the past five years alone, the industry has experienced a 44% increase in reference documents. This presents QARA professionals and departments with the challenge of updating regulatory requirements, while managing labor intensive tasks across siloed and complex systems.

The ever-changing Rubik's cube of regulations

The current landscape can be likened to a Rubik's cube, with each tile representing a different regulation that varies by country and product. As you pivot and rearrange the tiles on the cube, so does the regulation’s relationship change with the geography and product. Just when regulators believe they have come to understand certain regulations and jurisdictions, the cube will shuffle or expand. The rate of change occurring within the industry presents an immense challenge to QARA professionals.

QARA professionals are faced with the daunting task of identifying a wide range of product inputs essential for successful product registration. Deciphering the necessary data for variable global registration processes is critical for a smooth global product launch. These stakeholders navigate so many different variables, where context plays a key role. Local standards can vary with globally accepted standards and some non-medical regulations can affect medical products.

For example, the EU AI Act provides a comprehensive regulatory framework aimed at governing the development and use of artificial intelligence (AI) within the European Union. In the regulatory context, the EU AI Act applies a comprehensive risk-based approach to regulating digital medical products. New regulations, such as these, can create challenges for QARA professionals as they attempt to understand the overlap of these guidelines within the life sciences industry.

Leveraging technology and human expertise to manage complexity

With these challenges in mind, the question emerges, “How do QARA professionals succinctly explain the complexity of these regulations to a broader commercial audience?”

The focus of QARA is the provision of safe and effective patient care, in a manner that is commercially viable. Organizations require technology and resources to achieve agility in their regulatory decision-making and safety monitoring. The use of software and advanced technology in combination with human expertise offers an excellent resource to understand and navigate these evolving regulations.

Specifically, solutions with the ability to mine through structured and unstructured data, that can crawl through mountains of data, such as social media files, to identify product safety concerns. The principal purpose of these technologies is to allow the professionals to perform their roles to the best of their abilities. This includes the reduction of transactional administration, increased insights gleaned from data analytics and the reduction of risk through the connecting of disparate systems.

Ensuring data integrity and minimizing bias

As life sciences companies increasingly rely on AI-enabled solutions, the integrity of the data used becomes paramount. Maintaining data accuracy is essential for ensuring that AI-driven insights are reliable. This involves:

• Data verification: Organizations must implement rigorous processes to ensure that both structured and unstructured data are accurate and up-to-date.
• Minimizing bias: AI systems are only as good as the data they are trained on. Therefore, QARA professionals must ensure that data inputs are diverse and reflect the complexity of the markets they operate in to avoid bias in regulatory decisions.
• Human oversight: AI should be viewed as a tool that complements, not replaces, human expertise. QARA professionals must maintain oversight and validation of AI-generated insights to ensure that data integrity and safety remain intact.

Reframing regulatory processes for commercial advantage

While regulatory compliance is often seen as a burden, reframing it as an opportunity can provide life sciences companies with a strategic advantage. Regulatory data can provide insights that go beyond compliance. It can help optimize product development, marketing strategies and post-market surveillance by offering real-time feedback on product performance and safety. When regulatory frameworks are aligned with commercial goals, companies can be more agile in product development. Regulations are designed to ensure patient safety, but they can also be leveraged to improve product design and effectiveness, creating a competitive advantage.

The rising challenge of recalls

Concerns are mounting, as recalls have increased steadily in recent years. In particular, software related recalls are rising due to the increasing sophistication of medical device technology. Following a major recall, a company's shares can decrease by up to 10%, impacting both financial performance and reputation. These trends suggest that life science organizations should prioritize comprehensive systems to record potential safety events.

The role of quality and regulatory systems is to remediate potential patient safety and product quality concerns. In a post-market landscape, recalls should not be discouraged. Identifying recalls provides organizations the chance to improve product safety and the quality of patient solutions. Gathering post-market information requires a significant amount of intelligence to process and identify product safety issues. Post-market information is also a critical component of the product development lifecycle. Learnings from post-market information should drive knowledge and improvements in pre-market activities.

Achieving agility through technology and expertise

The role of QARA professionals is evolving rapidly in the face of new regulatory challenges and technological advancements. By leveraging AI-enabled technologies alongside human expertise, life sciences organizations can not only stay compliant but also drive innovation, improve product quality and protect patient safety. With the right systems in place, quality and regulatory processes can be reframed as a strategic advantage that helps organizations deliver safer and more effective products, all while navigating the ever-shifting regulatory landscape and within a company’s financial constraints.