Abstract: The application of IDMP in regulatory practice is advancing, in particular in Europe with EMA’s Product Management System and Product User Interface taking shape. The presentation will shed light on what happens meanwhile in the background. Authority projects like FDA’s Project Orbis and industry projects like Accumulus Synergy’s cloud-based platform pave the way to submissions consisting exclusively of structured data. Such developments put a constant evolutionary pressure on RIM systems like Generis Cara to adapt.

Felix Spenkuch

Abstract: A dive into the world of interconnected processes and information shows how you can join your teams and their work to deliver new efficiency and digital transformation with CLS. The AI Roadmap for CARA

James Cook

Abstract: Steve Gens and Preeya Beczek will jointly present 5 key practices to improve how regulatory information is effectively managed globally. This will be based on Gens & Associates research of over 140 organization, 320 local affiliates, and the speakers’ practical experiences. This dynamic session will incorporate audience participation via real-time polling with focus on improving: 1) process efficiency, 2) data quality and governance practices, and 3) technology application. Steve will also provide a glimpse of the early results to the 2024 World Class RIM: Extending the Power of RIM benchmark.

Steve Gens

Preeya Beczek

Abstract: How to onboard a large number of users to a single enterprise-wide platform is already a challenge. If the basis from where you start is a complex system of responsibilities and a matrix organization with many layers of hierachy it adds some challenges. And if you start to rebuild the overall operating model of the company in paralell the challenge is perfect. The presentation show how we handle that and why a high flexibility and agility on all ends of the project is important.

Michael Bald

Abstract: Data standards are the bedrock of global digital transformation. In this presentation, we will explore the current state of data standards on a global scale, with a particular focus on their impact on life science companies. We will discuss how these standards are facilitating enhanced interoperability, improving efficiency, and driving innovation in the life sciences sector. Furthermore, we will dive into the impact of the latest developments from EMA and the EU Network on the data and document management capabilities and (future) requirements. This presentation aims to provide an insightful overview of the data landscape and the impact in shaping the future of life sciences, while offering guidance for companies navigating this complex, yet compelling domain.

Remco Munnik

Abstract: Syneos Health regulatory consulting discusses the impact of implementing the Heads of RegOps (HeRO) - defined regulatory excellence framework from a talent, delivery and data perspective. This framework covers:
Talent and Organizational Excellence: Establishing a fit for purpose Reg organization, ops model & workforce equipped to achieve Reg Excellence Delivery Excellence: Optimizing submission strategy, compliance, process & technology to ‘get submissions right the first time’. Enabling process simplification and automation groups to streamline ways of working, embracing digitization through standardized and emerging technologies (e.g., RIM, AI, BPM) Data Excellence: Having the right data, in the right format, that’s reusable, driven by a robust data governance model

Caroline Masterman-Smith

Abstract: A study found that only 40% of ~300 data points required for clinical decision support and real-world evidence were available in structured data. So where is the clinically relevant data? It’s often found in unstructured clinician notes. This session will discuss examples of successfully utilizing NLP in the Life Science industry to extract valuable data for real-world evidence. Topics covered will include Observational Safety in Mental Health, Adverse Drug Event Detection and Building Patient Cohorts.

Karen Sundstrom Thomson

Abstract: Innovation is often synonymous with the deployment of a new technology, application, or approach. We hear lots of talk about it, particularly from software vendors and consulting firms, but it can be months or years later before we really know whether we have achieved something meaningful, whether it can really be attributed to an innovative process, and usually all for a significant unaccountable investment. I have spoken on the topic of Innovation in the past. These talks have included reviewing technologies, use cases, investment criteria and the business economics of innovation. But there is little emphasis on the success factors of innovation, its collaborative and motivational attributes, and often we rush into things because a cool new technology emerges, or our peers are doing it. Do we really understand what makes innovation work? In this presentation, I will explore how 12 business success factors can influence innovation acceleration, the origins of which are based in academic research and the application of which has been tested in other industries. I will describe a methodology of assessing a company’s readiness for innovation, providing a benchmark upon which to improve, and how this methodology can be an accountable innovation accelerator across the enterprise.

John Cogan