I had the great pleasure of attending Regulatory Affairs Professionals Society (RAPS) in Phoenix in September, attracting 1,700 participants from 41 countries across five continents. This was the first time since 2019 attendees were able to gather in –person for four days of educational sessions, expert presentations and panel discussions exploring the most pressing topics in medical device, IVD and pharmaceutical regulation for global markets.

This year’s educational program consisted of 196 speakers participating across more than 250 sessions. The event also featured an exhibit hall with100+ solution-providers showcasing the latest innovations in the healthcare regulatory sphere. They could also interact with peers during Solutions Circles or take part in interactive discussions held at two show floor stages.

The conference featured sessions on using real-world evidence, the future of vaccine regulatory pathways, the role of artificial intelligence in medical devices, developing decentralized clinical trials and moving forward with innovative manufacturing. Convergence had forums, with presentations from regulators from the European Medicine Agency, the Austrian Agency for Health & Food Safety, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency and the FDA.

Convergence 2022 also included a session on how to resolve disagreements with the FDA during pre-market review. The session entitled “With All Due Respect, We Disagree with FDA’s Assessment,” featured speakers from the agency’s ombudsman programs. Iyer, who moderated the session, said FDA officials proposed the topic. “They wanted to educate us on the routes that are available to people to lodge that disagreement in a constructive manner.” It really highlighted the direction of the regulatory bodies wanting full transparence.

Another session examined the future of patient experience data in global drug development. The agenda also created opportunities for attendees to elevate skills with tips on improving public speaking skills, best practices for identifying relevant regulatory intelligence and working for the FDA.

Overall my take away from what I was hearing in the talks, from other participants and looking back over the past several years, life sciences companies have faced mounting pressure from many directions, including increasing regulatory requirements, nonstop technological advances, and intense pricing pressure. With EUDAMED and other international agencies changing how they will ingest product data, data integrity and the ability to manage supersets of data is going to be of critical importance. And as the use of artificial intelligence, machine learning, and data lakes becomes more commonplace, we are going to see game-changing advances in areas like clinical trials, disease management, and drug discovery. The power of advanced analytics is going to transform entire organizations’ – people, process, and technology – and disrupt convention as we know it. And the unprecedented events in recent years have only provided more reason to modernize compliance and elevate the value and partnerships with regulatory bodies and external stakeholders. This is the only way we are going to be able to continue to bring cutting edge technology safely to the market.

To continue thriving and leading, life sciences companies must continue to meet the industry’s new challenges head-on, but many are learning it is not just digitalization of processes is simply not enough. This disruption is requiring life sciences companies carefully consider their technology vendors and form strategic partnership with forward thinking tech companies with knowledge in AI, robotics and cognitive automation, and cloud computing to ensure they do not fall behind regulatory bodies. Life science companies need to start thinking and operating more like agile tech companies as competition increases, and tech giants like Amazon and Google diversify into health care and life sciences. Today’s compliance and regulatory organizations have an opportunity to elevate their alignment with business needs and requirements and to respond more efficiently and effectively to external opportunities, challenges, and pressures. Modern compliance functions need to continue to be risk-intelligent and efficient. Compliance organizations have historically focused on point solutions and analyzing tactical, transactional data in search of what went wrong. Now is the ideal time for the compliance function to evolve its focus from hindsight to foresight. Moving the organization from defense to offense. Partnering with organizations to help them not only produce data, but manage the data that enables business growth. This generally requires modernization of the compliance function and new approaches to compliance and quality. Breaking the silo approach and leveraging connected systems to leverage automation. This will give companies the ability to make better informed decisions and enable innovation through a broader lens – capturing and analyzing data from design, engineering and manufacturing processes. Only then can companies effectively focus on quality using contextualized data from the entire product lifecycle. Which means embracing the right technology and services partners to accelerate their digital transformation and maximize digital technologies to create value-generating capabilities that support innovation and more modern cloud-compliant solutions.