Author Archives: Guest Blogger

Pharma Manufacturing Investments Reflect Key Industry Trends

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Pharmaceutical Technology’s Cynthia Challener offers summary of selected investments in both small- and large-molecule manufacturing facilities during the last year. Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in […]
Posted in Manufacturing | Tagged , , , , | Leave a comment

Google Glass — A User's Guide in Healthcare

Three medical affairs experts — Sean Turbeville, David A. Wells, and Charles Wolfus — review the capabilities of Google’s latest technology for delivering information to healthcare professionals in the field.
Posted in Guest Blog, healthcare, Op-Ed, Technology | Tagged , , | Leave a comment

60 Years of Pharma Regulation in Europe

European regulation of pharmaceuticals has, since the foundation of the European Union around 60 years ago, been a story of medicines being controlled in a collaboration between regulators at the EU and national levels. In recent years, this collaboration has been extended to involve not just the regulators themselves but also other stakeholders such as […]
Posted in Europe, Regulatory, Safety | Tagged , , | Leave a comment

Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, […]
Posted in Biotech, Europe, Regulatory | Tagged , | Leave a comment

Five Steps to Data Integrity

Siegfried Schmitt offers some steps that manufacturing companies can take to ensure data integrity. In general, media tend to report on the most serious data integrity violations uncovered by regulators. Often when companies find similar issues through their own internal investigations, they remain confidential and unreported. It would, therefore, be presumptuous to assume violations reported on […]
Posted in Manufacturing | Tagged , , | Leave a comment
  • Categories

  • Meta