Session 7

Innovative medicine manufacturing in the European Union

Fast path from innovation to safe and effective medicines

Organised by the European Medicines Agency

The ongoing revision of the EU regulatory framework for pharmaceuticals provides a unique opportunity to create a connected and simpler regulatory system that enables innovation to transform our healthcare systems in Europe. Furthermore, innovation cycles have changed – not least because of digital automation and AI, as well as advances in the field of personalised medicine - and regulators are challenged to keep pace with these developments.

With this in mind, this session will focus on how the European Medicines Agency, together with the European Regulatory Network, support innovation in the EU across the lifecycle of a medicine, with specific reference to innovative manufacturing. The use of novel manufacturing technologies and analytical techniques for the design, manufacture, and quality control of medicines can help not only improve the quality of medicines, but also improve the supply of existing ones and facilitate the adoption of more sustainable practices with a reduced carbon footprint. New technologies can also bring manufacturing closer to patients, right to the point of care.

The session will highlight international collaboration and case studies that have accelerated the manufacturing of innovative medicines and explore how the revision to the EU pharmaceutical legislation will further enhance support for innovation. It will also discuss the challenges of incorporating new manufacturing methods into regulatory dossiers.

Speakers to be announced