The importance of the 2024 ISPE Europe Annual Conference is evident with the continuous challenges the pharmaceutical industry is facing in terms of drug shortages, regulatory requirements, digitalization, automation, and big data management.
It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...
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,...
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of Quality Intelligence II, FDA, presented the regulatory keynote at the 2024 ISPE Facilities of the Future...
Artificial Intelligence (AI) can be described as the application of computer science, statistics, and engineering, utilizing digital algorithms or models to analyze information, perform tasks and exhibit behaviors such as learning, making decisions, and making predictions.
One of the keynote sessions of the 2023 ISPE Pharma 4.0TM and Annex 1 Conference held 11 - 12 December 2023 in Barcelona, Spain was a presentation on European Union (EU) initiatives to...
The energy in the room was palpable as attendees eagerly awaited the start of what promised to be an enlightening and thought-provoking evening.
ISPE’s Regulatory Quality Harmonization Committee (RQHC) is structured with four Regional Focus Groups (RFGs): Asia-Pacific, Europe/Middle East/Africa, Latin America, and North America. The RFGs support ISPE in its understanding and response to regulatory issues and concerns for the specific region. The RQHC Asia-Pacific RFG includes pharmaceutical professionals located in or having specific...
