European Pharmaceutical Review Issue 2 2019
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the essentials in QbD, process and analytical controls.
Included in this issue:
- REGULATORY INSIGHT
Are you giving regulatory intelligence the platform it deserves?
Jürgen Hönig and Rob Williams, PharmaLex
Potential impact of Brexit outside the UK/EU
Paul Ranson, Morgan Lewis
- BIOPHARMA PROCESSING & DEVELOPMENT
Emerging NMR techniques as advanced tools for characterising biological parenteral products
Yongchao Su and Wei Xu, Merck & Co and Bruce Yu, University of Maryland School of Pharmacy
Essentials in QbD, process and analytical controls
Thomas A. Little, President/CEO Thomas A. Little Consulting, BioAssay Sciences
- FORMULATION, DEVELOPMENT & DELIVERY
Expecting the unexpected
James Mellman, Novartis
It’s not just about the science
Paul J Newby, Alice Laures and Lisa Wysocki, GlaxoSmithKline
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Analytical techniques, Biologics, Biopharmaceuticals, Distribution & Logistics, Drug Discovery, Drug Safety, Endotoxin, Formulation, Freeze Drying, Good Manufacturing Practice (GMP), Lab Automation, Manufacturing, Microbiology, Packaging, Process Analytical Technologies (PAT), QA/QC, Quality by Design (QbD), Regulation & Legislation, Vaccines