A panel discussion at the 2026 ISPE Europe Annual Conference brought together leading regulators from Europe and the US to explore how regulatory leadership is evolving in an era of rapid technological and scientific change, including digital transformation efforts, GMP modernization, the maturation of quality risk management, and introduction of artificial intelligence (AI). The panel also...
This article presents experiences from seven recent accelerated development program case studies. These experiences provide insights that could help companies progressing through accelerated development programs for products meeting unmet medical needs or significant therapeutic needs, such as those with anticipated Breakthrough Therapy (United States) or PRIME (European Union) designation.
On the final day of the 2025 ISPE Annual Meeting & Expo, regulators and senior industry leaders convened for the Global Regulatory Town Hall—a long-standing and popular feature of the annual event. The discussion focused on the growing impact of digitalization and the increasing use of artificial intelligence (AI) by both regulators and industry. The session featured a mix of pre-prepared...
ISPE successfully assisted Health Canada with International Council for Harmonisation (ICH) Q13 implementation training in virtual sessions with 170 participants.
In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International...
Regulators from the European Medicines Agency (EMA), the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), and the Austrian Agency for Health and Food Safety (AGES) addressed the rapidly evolving landscape of pharmaceutical regulation in the digital age on 14 May at the 2025 ISPE Europe Annual Conference in London, UK. The panel discussed key areas shaping the...
