27 June 2019 - 27 June 2019
Requirements for Highly Active Substances in API, Pharma and Biotech ISPE Nordic is organising a conference in Copenhagen this year and would like to invite you to participate the 27 June 2019. The conference is a co-operation with ISPE Dach and will...
29 April 2019 - 29 April 2019
This year ISPE-DVC celebrates our 26th Annual Golf Classic. With your participation and support, we hope to make this year one of our very best outings ever! Once again, this year’s outing will be held at the Philmont Country Club in Huntingdon...
16 April 2019 - 16 April 2019
The April ISPE Education program is going retro with a focus on the Fundamentals of Engineering. This event will provide a refresher on the engineering behind some of the basic equipment and systems we use in the FDA regulated industries, such as...
As regulatory agencies invite public comment on a new or revised regulation or guidance they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we can provide...
iSpeak Blog

The pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to construction, particularly the delivery of critical infrastructure such as laboratories, cleanrooms, and research facilities, many companies in the sector still rely on traditional building methods.

Audio file
2025-07-01T08:57:34

In part one of our two-part series on the future of ATMPs, David Phasey, Business Development Director at 3P Innovation, joins the podcast to discuss the drivers of the high cost-of-goods (COGs) for ATMPs and how automation can help reduce these COGs

iSpeak Blog
As I approach the six-month mark in my role as President and CEO of ISPE, I’ve been inspired by the energy and commitment of our global community. One of the most meaningful experiences so far was from a recent visit to Shanghai, China, for the 2025 ISPE China Conference hosted by the ISPE China Office—an event that marked the official restart of ISPE’s presence in China.
Affiliates/Chapters News & Press Releases
19 June 2025
SaaS validation proved to be a topic of a lot of interest for all attendees joining ISPE GAMP CoP Benelux event on June 19th, hosted by UCB, Anderlecht. The event was opened by Natasja Bastiaens, ISPE GAMP CoP Benelux Chair and the event sponsor UCB...
Good Practice Guide: Validation 4.0
The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient safety throughout a pharmaceutical product's lifecycle. A Holistic Control Strategy (HCS) in this context means moving beyond traditional, static, upfront and localized validation controls to a dynamic, data-driven, and continuous approach to managing risks and quality along the broader value chain.
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