Report of LLF Regulation Event #1
We have now complied a new report is synthesizing the highlights of the first public webinar of the LifeFactFuture project on regulatory issues related to pharmaceutical manufacturing. Specifically, the February 5th webinar addressed the upcoming update of the Annex 11 of the GMP regulation which pertains to the use of computerised systems.
The webinar was very well attended with more than 100 participants online representing several universities, regulatory authorities, and more than a dozen Finnish and international companies.
For the webinar keynote, Ib Alstrup (Danish Medicines Agency) presented the status of the revision. Since the revised draft has not yet been released for public consultation, some details are still tentative. However, the direction of the changes is very important for the pharmaceutical industry in Finland, and the presentation raised several important points. For example, the new regulation clarifies requirements and highlights that responsibility for compliance is always on the regulated user. It is not possible to hide behind third-party vendors claims that certain information cannot be procured. Furthermore, it was abundantly clear that future GMP regulation is not only affecting new possible processes and use cases, but also increasingly restricting traditional (e.g., paper-based) practices.
Furthermore, the regulatory agencies provided clear endorsements of using digital technologies, including AI technologies. This was a very important and positive signal for LifeFactFuture’s target goal, namely accelerating the digital transformation of Finnish life science manufacturing.
A big thanks to all the active participants and especially speakers Ib Alstrup (Danish Medicines Agency), Elina Asikanius (Finnish Medicines Agency), Toni Ahlqvist (University of Turku and LifeFactFuture PI), Sara Gambier (Bayer Oy), Pekko Mikkola (DAIN Studios), Hanna Soinio (Bayer Oy), Mirka Laavola (Finnish Medicines Agency), and Mia Sivén (University of Helsinki).
Stay tuned for the next LFF regulatory webinar on May 21st 2025!