ProductLife Group (PLG) announced the acquisition of Callisto, a UK-based consultancy specialising in Regulatory Affairs (RA), Pharmacovigilance (PV) and GMDP services within multiple regulated sectors.
Renato Rjavec, ArisGlobal, discusses how generative AI (GenAI) technology is transforming everyday regulatory and safety processes, thanks to its ability to summarise key insights and findings from across huge, diverse bodies of content and data.
Niamh Bissett, Director, Operations, PMO, West Pharmaceutical Services discusses Annex 1 and the Impact of Primary Packaging in our latest EPM Online insight.
Ramesh Ramani and RaviKanth Valigari, AI experts at ArisGlobal, explore how large language model-enabled AI will sharpen drug safety & regulatory practice.
Matthias Mikkelsen, Fill/Finish Systems Specialist, Flexicon Liquid Filling, Watson-Marlow Fluid Technology Solutions discusses how you can design your processes to be compliant with the new Annex 1 guidelines.
There is a real opportunity for AI to maximise Life Sciences companies’ investment in regulatory data management. ArisGlobal’s Agnes Cwienczek & Renato Rjavec set out practical examples of AI and Generative AI delivering tangible benefits.
It’s long been a concern for scientists and regulators that drugs are intended for use by anyone but are predominantly tested on one group – white men. Richard Staines reports on how this could change.
Mike Ludlow, Market Development Manager, Life Sciences; Element Materials Technology provides an assessment of single use systems for biopharmaceutical production and highlights the need for regulatory alignment.
Samantha Silver and Charlie Whitchurch from global law firm Kennedys explore some of the key legislative developments that will impact manufacturers operating in the life sciences sector as they enter 2024 for EPM.
Steve Gens of Gens & Associates discusses how a renewed focus on affiliate operations can contribute to resolving data gaps and eliminate inefficiencies within the processes.
The European Commission’s revision of its Good Manufacturing Practices (GMP) Annex 1 for sterile drug products will have implications for pharmaceutical companies that market their sterile drug products in the EU.
