The aim is to explore the potential of Digital Transformation and Pharma 4.0™ projects within the Life Science Industry. Enabling technologies alone are not the answer to challenges that our industry has to face, but they are a key element of a wider solution, inclusive of revised business and compliance processes, innovative and sustainable digital solutions and equipment and, as a key enabler, new organization and culture.

New opportunities offered by recent and emerging technologies are completely changing the game and making new scenarios possible, even the ones considered impossible a few years ago. Our goal is to deep dive transformational, but industry proven, ways of extracting benefits from Digital Solutions that combine one or more innovative enabling technologies, like: GxP Cloud, Smart and Wearable Devices, Collaboration Platforms, Big Data and Advanced Analytics, Industrial Internet of Things (IIoT), Artificial Intelligence / Machine Learning (AI/ML), Process Mining, Natural Language Processing, Image Recognition, Advanced Modeling, Advanced Robotics, Augmented Reality (AR), Virtual Reality (VR), Additive Manufacturing, Robotic Process Automation (RPA), but also the ones less mature in our industry like: Biometric identification, Blockchain, Speech and Gesture Recognition, Edge Computing and Quantum Computing.

Each case study to be eligible should clearly share the problem statement, the solution, the benefits (whenever possible quantitative - the dimension of the project, involved Users, timelines), the constraints, and lesson learned. Best will be to have, at least as co-speaker, a representative of the case study owner company.

Inspections and compliance assessment remains a core aspect of pharmaceutical regulation. In recent years there has been increasing focus on internationally harmonized standards across the pharmaceutical development lifecycle. This enhances risk based audit and inspection models and facilitates reliance. As this practice adapts to new industry ways of working, there is increasing expectation for knowledge sharing across GxPs and learning from the inspections of other organizations. Using examples from audits and inspections across the product development lifecycle, this track will:

• Explore how models for organizational maturity and compliance management will impact audit and inspection planning
• See how innovation in treatment modality and technology is driving new audit and regulatory inspection models
• Hear current trends in regulatory findings from GxP inspections and learn from the experience of others
• Understand the available paths to pre-inspection regulatory engagement for innovative approaches, and learning how to prepare for success

Improving the availability of authorised medicines is a key priority for the medicines regulatory network. Drug shortages can occur for many reasons, such as manufacturing difficulties, problems affecting the quality of medicines or increased demand that can impact on patient care. Shortages or other problems with the availability of medicines create challenges for the medicine supply chain, with a potentially serious impact on human health.

Managing drug shortages is critical to ensure patient safety. Directing drug shortages requires an immediate short-term strategy and long-term strategic plans.

Long-term plans should focus on:

• Supply Chain: Strengthen the pharmaceutical supply chain and responses to future deficits and transparency in the drug manufacturing process.
• Technology: Implementation of new manufacturing technologies that are more reliable, improving the quality process.
• Stockpiling: Developing and re-thinking the strategic stockpile of medications. The FDA and WHO both have an essential medicines list that they find critical to have in stock. Having a three to six months stockpile of these medications may help effectively manage drug shortages.

This track will welcome presentations on the regulatory challenges, solutions and novel ideas that support short – and long-terms solutions to the above-mentioned areas.

Attendees will learn the ins and outs from the European projects that were recognized with the ISPE Facility of the Year Award (FOYA) in 2023, with presentations and discussions on engineering and project delivery with case studies.

Questions to be answered include:

• What are the right tools in engineering and project management to support efficient investment projects?
• What are the success criteria to deliver investment projects on time with the required quality?

Most failure points are constant basic data development, stakeholder alignment, permitting requirements (when and how to involve regulatory agencies), late commitment for investments, front end loading development, added complexity through new business needs (i.e. sustainability and reliability) and even the business case itself. It takes skill and patience on both the business and the technical site. Case studies and lessons learned will be presented around these topics.

Join our speakers and other subject matter experts to hear about several areas of interest in the computer system validation area, including how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA), how organisations are adapting to a CSA environment, the significant areas of progress and, conversely the remaining challenges.

Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software", many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11, this session will aim to cover the implications and opportunities of CSA draft guidance and GAMP 5 Second Edition on 21 CFR Part 11.

Updates from the AI/ML (Artificial Intelligence/Machine Learning) CoP will also be delivered with a focus on AI as to how it relates to computer systems.

Interactive sessions will also be included which will provide you with the opportunity to network and engage in discussions with GAMP subject matter experts. Please join us for what should be a very engaging and informative session.