Topic

Articles

David Basile, VP Technical Operations, Americas, Hovione, highlights some common mistakes made by pharmaceutical companies when maintaining manufacturing facilities and equipment.

Missteps in GMP Facilities and Equipment Maintenance

Pharmaceutical Technology®’s quality experts, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel discuss how pharmaceutical manufacturing training has evolved over the years and how the influx of new facilities is demanding a skilled workforce.

Onshoring Requires a Plan for Training 

Videos

André Cerbe, CEO of Schlafender Hase, spoke with Pharmaceutical Technology® about the disruptions the pharma industry faced in 2025 and how digital workflows will be key for success in 2026.

Integrated Digital Workflow Essential in 2026

How will plans to rework medicines legislation in the European Union impact drug development, innovation, and market exclusivity?

Innovation and Market Exclusivity in the EU

Executive Director Emer Cooke presents EMA’s achievements for the year.

EMA Director Sees Legislation Revamp as Highlight of 2025

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets. 


Ask the Expert: Training for a Skilled Workforce

Angeline Dhas is an AI Product Specialist for 

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

Accelerating HTA Readiness with Generative AI

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Gail Reed is senior scientist with Johnson & Johnson.

Yelena Ionova is senior manager, Data Strategy and Analytics with Redica Systems.

The authors detail a practical application of specification equivalence to excipients testing to achieve in-house harmonization.

Multi-Compendial Compliance for Pharmaceutical Excipients–Part 1: A Practical Application of Specification Equivalence

Ian Crone is vice president Europe & APAC Regulatory Solutions at ArisGlobal.

Life sciences is a decade behind other industries in its optimization and strategic exploitation of data. This is perplexing, given how much companies profess their ambitions to exploit AI. An industry podcast brought together life sciences thought leaders to debate the subject. The panelists noted that really, by now, standardized data should be yielding greater intelligence, and powering pharma’s future, accelerated by AI. If only companies could find new momentum to finally sort out their underlying data. This article sets out some of the key points that arose from the panel.

Is Pharma Solving the Right Problem with its Data Transformation Efforts?

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

FDA leadership initiated rapid drug review programs, enhanced transparency by publishing decision letters in real time, and strategically integrated AI into agency operations.

Quality Systems