iSpeak Blog
ISPE and the ISPE Foundation mourn the loss of a beloved member, mentor, and leader.
iSpeak Blog
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:
iSpeak Blog
Novel therapies refer to innovative and often groundbreaking approaches to treating medical conditions. These therapies typically involve new modalities aiming to improve upon existing treatments or to provide entirely new options for patients. The development of novel therapies is not immune to the challenges of standard therapeutic pursuits; however, the use of automation can significantly...
iSpeak Blog
In the bustling city of Boston, amidst the vibrant biotech community, the 2024 ISPE Biotechnology Conference will gather industry leaders and innovators for a pivotal set of discussions on Track 4: Lifecycle...
iSpeak Blog
The ISPE Advancing Pharmaceutical Quality (APQ) program team has been actively engaged with the US Food and Drug Administration’s (US FDA) Quality Management Maturity (QMM) program since its inception and along the...
iSpeak Blog
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently announced the adoption of the revised guideline
iSpeak Blog
The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.