Day 2 - October 22ndWednesday, 22 October 2025

• Since the first full version release of ESMP in January 2025, how is the platform working?

  • Current experiences of use and initial feedback

• Importance of accurate and standardised data for managing shortages

  • Link to IDMP data sets

  • How can stakeholders work together to increase shortage management efficiency and accuracy?

• Where are we with the latest revision for ICH M4Q?

  • Timelines and scope

  • What are the implications for industry and how can they prepare?

  • Link to SPQS and PQKM

Sometimes, a small step can spark major transformation. The introduction of the eCTD in 2003 marked a pivotal move toward the digitalization of the medicine registration process, aiming to speed up approvals and improve patient outcomes. In recent years, emerging standards have continued to reshape how medicines are registered, renewed, and updated.

• This session will explore how bi-directional collaboration between the pharmaceutical industry and regulatory authorities can be strengthened through the use of standards like eCTD, ePI, IDMP, and FHIR to support secure electronic health data exchange.
• An integrated application ecosystem that enables real-time connections between industry stakeholders and regulatory authorities is crucial for meeting the demands of modern, collaborative processes. By expanding existing standards at the annotation level, further progress can be made to accelerate assessment workflows. Participants gain insights into the vision of a connected digital landscape that facilitates immediate communication and the exchange of real-time data, as well as provides actionable insights. As a result, the processes involved in approvals, variations, and extensions are time-optimized, leading to improved patient care.

• International status of global identifiers

  • Moving on from end-to-end showcasing into piloting

    • Who is involved?

    • Can others get involved?

• Link to CTADHL

• Current findings and plans for next steps

• Breakdown of current substance registration and data streamlining initiatives

  • How do they differ between EU, US, and other global regions?

  • Can industry streamline data to be suitable for both systems?

• Future of substance management

• Differentiating between master data management and regulatory information management

  • When to use which and which systems to implement

• Importance of effective master data management

  • Impact on other data and regulatory operation processes

  • Tips for enhancing efficiency

LORENZ Life Sciences will present the results of a recent pilot project conducted in collaboration with a health authority, evaluating the use of AI to automate non-scientific content checks in regulatory submission review. The pilot focused on low-risk, high-frequency submissions and tested AI’s ability to support reviewers by validating document completeness, variation classification, and procedural consistency. The findings show measurable reductions in review cycle time, improved review consistency, and significant resource savings. This session will highlight the pilot setup, key performance outcomes, and the broader implications for regulatory automation.

Take the final 90 minutes of the day to deep dive into a breakout topic of your choosing. Lead by a select group of facilitators, explore the topics relating to AI, regulatory soft skills, and more...!

• Viewing regulatory affairs as holistic, rather than siloed

  • Benefits and challenges

• Setting up a project team

  • Stakeholders to involve

  • Curating inter-departmental relationships

• How would this approach help in streamlining workload and enhancing submissions