It is not surprising that there are regulations and guidance specifically for ATMPs. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. A session at the 2025 ISPE Europe Annual Meeting in May 2025, presented by Jon Halling, Managing Director for...
The ISPE Baseline® Guide Vol 8: Pharma 4.0™ was published in December 2023 to help accelerate the adoption of digital transformation. In quoting the opening narration of the original 1960s Star Trek television series, Christian Wölbeling, Founder and Chair of the ISPE Pharma 4.0™ Community of Practice, likes to say, “To boldly go where no one has gone before.”
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large molecules and cell and gene therapies, has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in...
At the 2023 ISPE Pharma 4.0™ and Annex 1 Conference, held 11 – 12 December 2023 in Barcelona, Spain, a panel discussion that included regulators from around the world, as well as industry experts,...
