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There were many exciting subjects covered at the 2022 ISPE Pharma 4.0 Conference in Vienna recently. The Conference coincided with the publication of Annex 1 and proved to be a hot topic.

The ‘grandfather’ of Pharma 4.0, Christian Wölbeling, provided an excellent introduction and update on Pharma 4.0 with many other events that followed including the results of the most recent survey presented by Teresa Minero and Robin Schiemer. 

More and more companies are piloting Pharma 4.0 but clearly much more could be done to realise the many benefits. The Annex 1 regulatory panel discussions with the MHRA (Alan Moon), EMA (Roberto Conocchia) and FDA (Rick Friedman) provided one of the first opportunities to discuss the new regulations in detail. 

“The authors of the revised Annex 1 are preparing training for the agencies and it was made very clear that Annex 1 is truly a global set of regulations that represent quite a large step-change in GMP requirements. PM Group was well represented at the event and able to contribute to the many important discussions that will help shape future progress.  Congratulations to the ISPE for another excellent conference,” said Alf Penfold, Group GMP/Regulatory SME, PM Group.

The 2022 Pharma 4.0 & Annex 1 Conference in Vienna, Austria was finally held on 7-8 December following a postponement due to COVID.  In retrospect, holding the conference a year later worked very well with the publication of the revised Annex 1 in August just three months prior to the event.  This was reflected in the conference being sold-out with a record number of people attending in person. 


Emerging leaders

There was also a focus on students and recent graduates with expert training sessions and the annual ISPE Pharma 4.0 Emerging Leader Hackathon. The two-day event was hosted by Takeda at its biotech campus in Austria and supported by numerous industry sponsors and coaches.

Over 50 people took part in the Hackathon challenge “A Hands-on Pharma 4.0 Blueprint Manufacturing Exercise where Digital and Quality Matter”. To deliver innovative and patient-centric results, the different work streams aligned with business and manufacturing priorities, such as data-driven and paperless production, automated workflows, in-process controls, plug-and-play, real-time monitoring and design-by-quality. The winning team presented a business case that showcased new approaches on simulation and data analytics.

Miriam Kremer-van der Kamp, Process Engineer, PM Group helped to organize the event as a member of the Emerging Leaders DACH Group. “The event was a huge success and shows what is possible when you are a member of the ISPE and become involved in growing the organization. We are very grateful to our host Takeda and all the coaches and sponsors,” said Miriam.

Additional support was provided by : Hamilton, Siemens, Endress+Hauser, Biosolve, Copa-Data, Biopharm Services, Sartorius, DataHow, Tulip, FrontWell Solutions and Applied Materials