ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality Lifecycle Implementation (PQLI)® committee, continued their series of training events with a well-attended course delivered to Singapore’s Health Sciences Authority (HSA) in November 2024.
At the 2024 ISPE Annual Meeting & Expo held in Orlando, Florida, USA, in October, a panel of global regulators and industry professionals addressed harmonization and regulatory convergence, digitalization, particularly the use of artificial intelligence (AI), and supply chain resilience.
In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, to address the barriers to technological innovation in the pharmaceutical industry. The first activity of the initiative was to conduct a three-part survey of ISPE members to understand the circumstances and confirm the sources that create barriers to...
At the 2023 ISPE Annual Meeting & Expo held in Las Vegas, NV, USA on 18 October 2023, a panel of global regulators answered questions submitted by attendees. The panel consisted of Paul Gustafson, PIC/S...
Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual drug shortages.
ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for Patients,” in support of the aspirations of many regulatory agencies globally to promote introduction of innovative pharmaceutical manufacturing.
