At the 2025 ISPE Europe Annual Conference held 12-14 May 2025 in London, the European Medicines Agency (EMA)’s Head of Quality and Safety of Medicines Department, Evdokia Korakianiti, highlighted the many...

Pharmaceutical manufacturers are always under pressure to move faster, stay compliant, and deliver high-quality products in a constantly changing landscape. The Manufacturing, Quality Control, and Operational Excellence

Tracy Gu’s first in-person experience with ISPE’s Women in Pharma took place at the 2023 ISPE Annual Meeting & Expo’s Women in Pharma® Committee Meeting. Tracy stepped into the room full of energy and curiosity and was just beginning her

In a world defined by rapid scientific progress and evolving market demands, the ability to adapt, innovate, and sustain excellence is no longer optional—it’s essential. The 2025 ISPE Biotechnology Conference,...

Each issue of Pharmaceutical Engineering^® covers a wide range of topics relevant to the pharmaceutical industry, including scientific, technological, and regulatory advancements throughout the entire...

At the 2024 ISPE Annual Meeting & Expo, a session titled “Regulatory Surveillance and Advocacy” was presented by Christine Moore, PhD, Executive Director, Quality Systems and Compliance at Organon LLC. Moore spoke about the definition of regulatory surveillance of policy and standards, and going beyond surveillance into regulatory intelligence, specifically related to inspections and...

Pharma 4.0™ represents a transformative shift within the pharmaceutical industry, redefining how medicines are developed, manufactured, and delivered. At its core, Pharma 4.0 involves the integration of advanced digital technologies...

Biomanufacturing is advancing rapidly, and as the industry evolves, so too must the facilities that support it. Therapeutic modalities are becoming more diverse, and with the increasing demand for speed, flexibility, and sustainability in production, biopharmaceutical facilities must be prepared to meet these new challenges.

Nathan Roman is a Director, Industry Advisor, and Global Brand Ambassador with Ellab. He has been an ISPE Member since 2004. In the question-and-answer interview below, Roman reflects on why he joined ISPE, how ISPE has impacted his career, and more.

Biotech companies are meeting modern sustainability objectives and gaining a competitive advantage by implementing process intensification strategies and continuous manufacturing technologies to improve production efficiency while reducing impacts on our environment. Attendees will learn about innovative approaches to process intensification, continuous manufacturing, and sustainability in...

In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a survey on the adoption of integrated C&Q, focusing on the use of paperless/digital systems for planning, executing, and reporting C&Q activities. According to the survey, 74% of respondents anticipated using digital validation tools (DVTs) for C&Q by 2024. “Over the last five years,...

In the pharmaceutical industry, disaster recovery is not just about protecting business continuity; it is about safeguarding patient safety, data integrity, and the entire supply chain. The increasing complexity of global pharmaceutical operations exposes companies to a broad spectrum of risks, ranging from man-made disasters such as geopolitical conflicts to natural disasters that can cripple...

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.