Conference Highlights

As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased exponentially — all while maintaining, or preferably reducing, the cost of goods. This year’s Manufacturing, Quality Control (QC), and Operational Excellence content track aims to address some of the many components that go towards realizing those expectations.

Rise of the Machines 
It becomes clear that a topic has become mainstream when it crosses multiple Communities of Practice and areas of interest. In preparation for the 2024 ISPE Annual Meeting & Expo, the Digital Transformation track committee worked closely with multiple teams from other tracks on the topic of artificial intelligence/machine learning (AI/ML) to identify the best and most appropriate tracks and sessions to present. To ensure the best program possible, the track teams took extra care and attention to make sure it would be possible to attend all of the AI/ML sessions irrespective of track across the conference’s five tracks of concurrent education sessions.

The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP (Emerging Technology Program), and the European Medicines Agency (EMA) with the Quality Innovation Group (QIG). There are also ongoing collaborative initiatives such as Orbis, ACCESS, and the International Coalition of Medicines Regulatory Authorities (ICMRA) that exemplify the effort of health authorities to provide potentially faster access to medicines for patients around the world.

Building off the success of the 2023 ISPE Annual Meeting & Expo, the program committee has developed a robust workshop program, taking place Sunday, 13 October, which is based on the practical application of the ISPE Baseline Guide and ISPE Good Practice Guide (GPG) Series, covering the following key areas: