International Conference on Harmonisation (ICH)

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Regulators commit to collaborating on RWE integration

29 July 2022 | By Hannah Balfour (European Pharmaceutical Review)

Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.

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Continuous biomanufacturing – where are we now?

28 October 2021 | By Hannah Balfour (European Pharmaceutical Review)

The biopharmaceutical industry is driven by the need to increase production and reduce costs, while maintaining product quality – and has increasingly been focused on intensification of processes to accomplish this goal. In this article, European Pharmaceutical Review’s Hannah Balfour summarises the potential benefits of implementing continuous bioprocessing and manufacturing…

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ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management

11 November 2019 | By Dave Elder (JPAG Member and David P Elder Consultancy)

The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.