DIA EUROPE 2019

Digital solutions are already being rolled out in pharma R&D and pharmacovigilance, but the regulatory process remains largely manual and time consuming, with slow adoption of innovative digital approaches. However, new solutions are being developed to facilitate digital transformation in the regulatory environment. The combination of smarter working processes and proper use of innovative technologies will drive efficiencies in regulatory submissions while keeping high standards of quality and compliance. Ultimately this could translate into time and resource savings for marketing authorisations and post-marketing requirements that will revolutionise the regulatory environment. Evidently, there are already tools that provide basic automation support (compilation, publishing and storage/archival of documents). In this session we would like to focus on further gains these tech solutions can bring. We will pick up on some of the technologies such as Robot Process Automation (RPA), Artificial Intelligence (AI) or machine learning that are already to some extent present in the regulatory environment and later expand this discussion into more future approaches as e.g. support for intelligent drafting of key documents, automatic and intelligent compilation of dossiers based on latest regulatory intelligence screenings and the complete dossier processing throughout the life cycle. The interactive component will arise as we will have a session panel made up of regulators, industry experts and academia. These are the three stakeholders that need to jon forces in order to shape the regulatory environment into one that can embrace AI solutions.