Search results for " Europe"
Article
Global Expansion Shapes Drug Oversight
At the same time, FDA and the European Medicines Agency (EMA) annouced plans to expand their many collaborative programs, including renewal of a pilot program that allows for parallel review and consu…
Article
Q&As with Industry Leaders
…cess Development for Advanced Therapeutics
Felicity Thomas, Pharmaceutical Technology Europe
Peter Guterstam, Product Manager, Advanced Therapeutics Downstream Solutions, Cytiva
…
Article
2014 Manufacturing Trends and Outlook
…dation, and laboratory management titles at branded and generic-drug companies in the United States, Europe, and Asia. More than half of the respondents work for organizations that produce both small…
Article
Drugs, At What Cost?
Competition generated through established biosimilar pathways will drive down the high costs of biologics in Europe, the US, and some emerging countries. However, in markets with less rigorous IP prot…
Article
Navigating Emerging Markets: Middle East and North Africa
Turkey, for example, has introduced market exclusivity as part of its efforts to become a European Union (EU) member state and has introduced other reforms to bring greater consistency with the rest o…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
LC-GC Europe. 2008;12:615–22.
18. Krull IS, Liu X, Dai J, Gendreau C, Li G. HPCE methods for the identification and quantitation of antibodies, their conjugates and complexes. J Pharm Biomed Anal.…
Resource
International Conference on Harmonization
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmace…