Join the LFF Webinar on ‘Computerised Systems and GMP – Regulation of Digital Solutions in Pharmaceutical Manufacturing’

Wednesday 5.2.2025 at 12.00–15.00
Online in Teams

The LifeFactFuture consortium organizes webinars related to life sciences sector regulation. This topic is relevant to all companies in the field, from manufacturers to technology solution providers. Since the regulations for pharmaceutical manufacturing differ significantly from regulation of for medical device manufacturing, we will be holding two separate and targeted regulation workshops.

The first event will focus on issues related to pharmaceutical manufacturing. The webinar will specifically focus on the update to Annex 11 of the GMP regulation which pertains to the use of computerised systems. This covers all aspects of digital solutions for which companies must comply with within their GMP-related activities. Annex 11 is currently being updated, and the emerging regulation, including new sections on AI and ML, will be sent for public hearing soon (likely by end of 2024). During the webinar, the head of the EMA working group drafting the new regulation, Ib Alstrup from the Danish Medicines Agency, will present it. This is important information, as it dictates what is and what is not allowed in pharmaceutical operations.

The first event will be held on Wed 5 February at 12.00–15.00 (Finnish time). The second event addressing medical device regulation will be scheduled for a later date in spring 2025.

> Register for the webinar (closed)

Program:

12.00  ‘The Futures of Life Science Manufacturing – Introductions from the LifeFactFuture consortium’: Toni Ahlqvist (UTU), Sara Gambier (Bayer) and Pekka Mikkola (Dain Studios)

12.15  ‘The New GMP Annex 11: Changes and Cases’, presentation by Ib Alstrup, Danish Medicines Agency

12.45  Q&A and discussion with Ib Alstrup

13.15  ‘Reflection Paper on the Use of Artificial Intelligence in the Lifecycle of Medicines’, presentation by Elina Asikanius, Finnish Medicines Agency (FIMEA)

13.30  Short break

13.40  Interactive Miro session: Reflections, cases, and impacts for your own work – computerized systems and AI in pharmaceutical manufacturing

14.10  Panel discussion with Hanna Soinio (Bayer Oy), Mirka Laavola (FIMEA), Anne Juppo (University of Helsinki), Pekka Mikkola (Dain Studios) and Toni Ahlqvist (UTU).

14.45  Summary and closing the event

Further information:

Keijo Koskinen, LFF Interaction Coordinator
keijo.koskinen@utu.fi, tel. +358 44 594 1659