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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

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iSpeak Blog

Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...

iSpeak Blog

Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.

iSpeak Blog

Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan base, and an energy that electrifies the stadium. Some people are casual viewers—they check the scores, maybe attend a game now and then. Others are fanatics (sometimes even crazed fanatics). They wear the jersey, know the stats, engage in every play, cheer and yell at the team and opponents, and...

iSpeak Blog
As an ISPE member, one of the most valuable tools available is ISPE Engage—a powerful platform that connects members with the global ISPE community. In fact, based on a recent survey sent out to a select group of ISPE members, more than half of the respondents noted that ISPE Engage is their preferred way to stay engaged with ISPE. Think of it as a business-focused online professional platform...
iSpeak Blog

The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large molecules and cell and gene therapies, has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in...

iSpeak Blog

As we approach International Women’s Day 2025, this year’s theme highlights the importance of accelerating action. ISPE’s Women in Pharma® embodies these principles by creating a platform for connection, growth, and empowerment. Hear what these Women in Pharma® members have to say about the value of Women in Pharma on International Women’s Day.

iSpeak Blog

The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying ahead of the curve is not just beneficial—it's essential. Professionals need reliable, up-to-date resources to navigate the complexities of regulatory requirements, technological advancements, and industry best practices. This is where the International Society for Pharmaceutical Engineering...

iSpeak Blog

What does it mean to be a “team member?” What ideas come to mind in your favorite sport where you think of membership on that team or club?

What happens when you change the perspective to “team player?” What ideas come to mind then? Will the group have improved performance when it is full of team players rather than just team members?

iSpeak Blog

Chris Leman received the ISPE United Kingdom (UK) Affiliate Member of the Year Award at the ISPE UK Affiliate Annual Conference and Awards Dinner in London, Heathrow in November 2024. Leman was honored as ISPE UK 2024 Member of the Year in recognition of his incredible contributions which included leading the ISPE UK North West region, creating the new UK Commissioning and Qualification...

iSpeak Blog

The pharmaceutical industry continues to face increasing demands for more efficient and effective manufacturing processes, particularly when it comes to aseptic processing. With an emphasis on safety, sterility, and the quality of biologics and injectables, the field of aseptic processing is critical for delivering life-saving medications. ISPE invites all pharmaceutical professionals to join...

iSpeak Blog

In this blog post, ISPE Emerging Leader member Peyton Myers, details his experience in his first year as an ISPE member. Myers was attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient and earned a two-year membership with the organization as part of the

iSpeak Blog

Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each advancement moves on its own schedule, driven by its own unique forces. But sometimes there is a synergy, when advances in technology can help regulators to achieve their objectives and changes in regulation come at just the right time to enable a technology to be impactful. This interplay between...

iSpeak Blog

As the pharmaceutical industry continues to evolve at an unprecedented rate, the design and delivery of manufacturing facilities must keep pace with the associated changing requirements. The drivers for change are also diverse both with internal and external factors being relevant. For facility design this means a more focused risk-based approach is followed. The result is facilities which...