Regardless of your role and experience level with Regulatory Affairs (RA), the RAPS 2022 Euro Convergence event in Amsterdam holds tremendous learning and networking opportunities.
Attendees will have varied expectations and excitement as this will be the first in-person RAPS Euro event after two long years. As we all gear up for the conference, sharing my thoughts here about the recent industry trends, challenges, and what can be expected from this event, as this might help you navigate your way through it. See you in Amsterdam!
In recent times, regulatory requirements across health authorities have been adapting to changes in approach for submissions management, transparency, clinical trials, product safety, and compliance. While some of the changes discussed at the upcoming RAPS EU conference are a result of adaptation to changes due to COVID, many of the discussions relate in some way or form to a consequence of the industry's evolution as a result of technology. Whether it is a topic of the use of Real World Evidence, the change in EU regulations for CTIS, the use of technology in clinical trials, or rolling submissions, many of these are dependent on new technology that has enabled these changes and regulations.
As a case in point, the industry is preparing for the upcoming mandate by the European’s In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746, which came into effect on 26 May 2017 and will replace the European In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC. The time to meet those requirements is quickly approaching, with a need to comply by the 26th of May in 2022. This has come into play to adapt to higher technology adoption in the life science industry enabling more effective and safer treatment to patients with tracking of medical devices through UDI, a risk-based classification, and Transparency through the EUDAMED database and others. This is just one of many topics at RAPS that will focus on evolving changes across the industry that are both influenced and benefit from the applied use of advancing technologies. The EU is not alone, and as an example, the US FDA, in 2021, also provided guidance and invited the industry to take on challenges in artificial intelligence to spur innovation.
One of the main challenges emerging from evolving regulations, use of technology, and acceleration in clinical trials is the maintenance of country-specific versions of the same information to meet regional health authority requirements. Maintaining different processes for manufacturing, regulatory operations, submission, and trial regulations is easily one of the advancing next step challenges to address as the adoption of digital progress.
Staying on top of the regulations and approaches to stay compliant, the industry is applying technology to the management of large data sets for submission preparation, collection, and collating Intelligence to accelerate and improve regulatory strategy and submission documentation. We are already witnessing the application of machine learning-based predictors to regulatory filing success and automation technologies to speed the submission preparation timelines, compliance, and quality. As an outcome, a strong foundation of analytics and insights and a more strategic mindset in Regulatory Affairs is becoming more critical for any regulatory business function.
Regulatory Authorities frequently encourage innovation and promote the use of technology. Back in 2014, the FDA created the Emerging Technology Program (ETP) as a collaborative program where industry representatives can meet with the Emerging Technology Team (ETT) at the FDA. The objective was to discuss, identify, and resolve potential technical and regulatory issues regarding developing and implementing a novel technology for filing regulatory submissions. In Jan 2011, the FDA issued guidance on SaMD and AI to spur innovation. Recently the FDA announced it is creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products, and medical devices through 21st-century manufacturing technologies. The industry is now proposing data sharing through Accumulus, and Health authorities are willingly exploring this.
But collectively, the sector has lagged. The industry needs to be willing to take on the challenge and spur innovation in regulatory Intelligence, drug development, manufacturing, and patient-related support to keep pace with and be in sync with regulatory authorities.
With all this at the back of our minds, let us look at RAPS Euro 2022 and what can be expected from it. I am sure we will find answers and more thought-provoking inputs around our challenges, aspirations, and journey towards future-ready RA.
While you glance at the overall programme agenda, you will see that the conference encompasses pharmaceutical and medical device tracks. Look out for the specialty topics focused on technology and artificial intelligence and sessions focused on biosimilars, and regulations for MDR in devices, paediatric regulations, and the new CTIS regulation. Topics on changes impacted due to COVID, and topics that provide recommendations and best practices in regulatory operations, including assessment of regulatory success, compliance, quality management, regulatory strategy, and submissions planning.
Another notable track that should get your attention is about the European Commission's changes, which has proposed a progressive rollout of the new In Vitro Diagnostic Medical Devices Regulation to prevent disruption in the supply of these essential healthcare products. The unprecedented challenges of the COVID-19 pandemic have diverted resources, which allows for the regulation's progressive rollout until as late as 2027.
My team and I will be at exhibitor booth #1 and look forward to having you there. In case you might be interested, here is a paper we published a few months back on the new centralized European Clinical Trial Information System. Happy to discuss it further with you in person.