Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?
Both are enablers for modern, digital, and automated processes as well as for professional development. Training opportunities using virtual reality (VR) technologies or virtual mockups and how to apply emerging and digital technologies for continuous and real-time monitoring are examples of how the Pharma 4.0 guidelines can be used to support Annex 1 implementation. The next 10 years will certainly be the most exciting in pharmaceutical manufacturing, specifically as it pertains to advancements in sterile drug manufacturing in the advent of Pharma 4.0.
In the blog post below, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference Chairs, Line Lundberg-Nielsen and Richard Denk, explain their roles in the industry and involvement in the conference. This year’s conference will take place 10-11 December 2024 in Rome, Italy, and virtually.
Insights from the 2024 ISPE Pharma 4.0™ and Annex 1 Conference Chairs:
Introduction from Line Lundsberg-Nielsen
Hello, I’m Line Lundsberg-Nielsen, the Pharma 4.0™ Co-Chair of the 2024 ISPE Pharma 4.0™ and Annex 1 Conference. I am working on global drug product capacity expansion projects where one of the main drivers for designing some of these facilities are that they must be Annex 1 compliant and digitally connected with the power of predictive capabilities. I have been involved in the ISPE Pharma 4.0 activities from the early days—it is fascinating to see how we are now really kicking off digitalization projects when designing new facilities. This conference is extremely valuable to me in my daily job as it covers both the Pharma 4.0 and Annex 1 aspects, including the digital transformation of our industry and how it also impacts what we focus on in ISPE.
Introduction from Richard Denk
Hello, I’m Richard Denk, the Annex 1 Co-Chair of the 2024 ISPE Pharma 4.0™ and Annex 1 Conference. I’m working extensively on the implementation of the EU-GMP Annex 1—in current installations and to support the design of new installations. From my perspective, the most interesting topics related to Annex 1 are the next generation of fully automated transfers, fill-finish with robotics and how to design them fully in Annex 1 compliance. Earlier this year, I was invited to the EMA Annex 1 inspector training by the European Commission. This was a great honor and has been a personal highlight for me this year. During the training, I was able to talk about the implementation of Annex 1 and the integration of new technologies such as robotics as they relate to Annex 1, . I’m looking forward to engaging in many discussions on this topic at the conference in Rome, Italy, and meeting many regulators as well as pharmaceutical professionals within the industry.
When the Pharma 4.0™ and Annex 1 conference was initially launched many years ago, it was a must-attend for both of us. This continues to be the case to this day. The topics of Pharma 4.0 and Annex 1 have fascinated us for years. In relation to Annex 1, Richard was able to join the ISPE Regulatory Commenting team after the first draft publication of EU GMP Annex 1 in 2017. Richard found his discussion with other ISPE colleagues to be extremely valuable and noted the team was also able to contribute a lot of input to the final publication of Annex 1. Richard was inspired by these discussions and founded the ISPE DACH Affiliate Special Interest Group Future Robotics. Line’s focus, particularly as co-chair of the ISPE PAT & Lifecycle Control Strategy CoP, was on advancing, digitalizing, and integrating the control strategy. We were both able to share this knowledge as co-authors of the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition).
The topics of Pharma 4.0 and Annex 1 are of huge interest, not only to us but also to ISPE members and to the industry at large. When we opened the call for proposals for this year’s conference, we received nearly 100 abstracts with the majority of them focusing on Pharma 4.0. Companies, ISPE members, and professionals across the pharmaceutical industry see the need to change the way pharmaceutical products are manufactured and recognize the need for expediting the delivery of products to patients. This can be done with knowledge-sharing to help everyone work even smarter. We love to share ideas and learn from each other. That is why this conference is so valuable. We have chosen 24 abstracts to feature at this year’s conference and have structured them into attractive tracks that should provide you with lots of inspiration and discussion opportunities.
The conference kicks off with a general session of amazing keynote speakers, all addressing different aspects of how to manufacture for the future, which will set the scene for the entire conference. Uwe Bücheler, PhD, of Boehringer Ingelheim, will deliver a perspective for the future of biomanufacturing; Flemming Dahl, with Novo Nordisk, will share how to scale to serve more patients; and Malcolm Jeffers, with IAAE, will discuss how to equip the people who will be working in these new facilities. Chris Grail of Bayer will talk about the value and drivers for Pharma 4.0 and Christina Meissner and Ronald Bauer, PhD, AGES/Austrian Agency for Health and Food Safety, will give us an insight into the data management requirements for sterile manufacturing processes.
With a vibrant exhibitor area, plenty of networking breaks, and a Welcome Reception on the first evening, the conference will be the place to expand your network and accelerate your projects. At the conference, you will not only be inspired and learn, but also meet colleagues working in similar fields as you, creating a network that you can reach out to and discuss with technology professionals.
There is no better way to round up the 2024 conference year than by attending the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December 2024 in Rome, Italy. We hope to see you there in person!
