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Dave Elder (David P Elder Consultancy)

 

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Approval of regulatory starting materials

27 October 2020 | By

There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…

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Continuous manufacturing: ICH Q13

26 August 2020 | By

Although steps have been taken to enable the implementation of continuous manufacturing in industry, a lack of global harmonisation in regulations has slowed the adoption of this promising emerging technology. Dave Elder discusses how ICH Q13 seeks to provide a harmonised approach to support this important initiative.

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Patient adherence: the true costs

25 June 2020 | By

Adherence to medicines – ie, maintaining consistency and complying with correct dosage – is vital for treatment success, yet patient non-adherence remains a global concern, risking a multitude of consequences for both the patients and healthcare systems. Dave Elder explores the issue of medicine adherence and expounds on current efforts…