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VIRTUAL ROUNDTABLE HIGHLIGHTS: Emerging tools for the analysis of biologics and biosimilars

28 June 2021 | By

In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…

article

European Pharmaceutical Review Issue 3 2021

23 June 2021 | By

In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…

webinar

Navigating the transition from IVDD to IVDR

9 June 2021 | By Tecan

This on-demand webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.

webinar

Quality assurance and data integrity from an auditors’ viewpoint

21 May 2021 | By Thermo Fisher Scientific

In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.