Conference Highlights

In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December in Rome, Italy, and virtually, will feature a track titled, "How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation." This track will bring together experts from various fields to discuss the integration of digital technologies and regulatory frameworks in the development journey of ATMPs, as well as provide insights into real world implementation data and lessons learned. With a focus on enhancing compliance, efficiency, and accessibility, the track will feature six engaging talks and provide attendees with valuable insights into the future of this rapidly evolving sector.

The pharmaceutical industry is on the verge of a profound transformation, driven by the digital advancements of Pharma 4.0™. This shift is set to redefine the design and construction of interconnected facilities, streamlining operations and optimizing production like never before. At this year's 2024 ISPE Pharma 4.0™ and Annex Conference taking place 10 – 11 December in Rome, Italy, and virtually, industry leaders will explore cutting-edge strategies for building smart, flexible, and interconnected facilities that align with the future of manufacturing.

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?

The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of Pharma 4.0™ and the updated Annex 1 guidelines. These changes are introducing innovations that not only enhance the quality and safety of sterile manufacturing but also leverage new technologies to optimize efficiency and compliance. This track will bring together industry experts to discuss how Pharma 4.0 principles can support the implementation of Annex 1. From contamination control strategies to robotics and data-centric architectures, these sessions will provide attendees with actionable insights and solutions to stay ahead in an evolving regulatory landscape.