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David Elder, PhD

David Elder studied chemistry at Newcastle upon Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in crystallography. He is a visiting professor (King’s College, London). David has 44 years of experience at a variety of different pharmaceutical companies (Sterling, Syntex and GSK). He is currently a CMC consultant. In addtion, he is a member of the British Pharmacapoeia (Expert Advisory Group PCY: Pharmacy), a Fellow of the Royal Society of Chemistry (RSC), UK and the immediate past chairman of the Joint Pharmaceutical Analysis Group, UK. He has presented regularly on drug development and drug delivery. He has over 160 publications and given 178 external presentations at scientific symposia. He has co-edited two books: the Analytical Characterisation and Separation of Oligonucleotides and their Impurities and ICH Quality Guidelines: An Implementational Guide


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Published Content
Total: 3
Pediatric Drug Development: Key Considerations and Challenges content piece image
Article

Pediatric Drug Development: Key Considerations and Challenges

Pediatric medicines are vital to the health and wellbeing of children. Nevertheless, a core principle in any pediatric drug development program is that “children should not be enrolled in a clinical study unless necessary to achieve an important pediatric public health need”. As such, the balance of risk and likely clinical benefits must be assessed and the child should not be adversely impacted by enrolment in the research study.
Risk Assessment and Expert Review of N-Nitrosamine Contaminants content piece image
Article

Risk Assessment and Expert Review of N-Nitrosamine Contaminants

In this article, David Elder discusses the identification of N-nitrosamine impurities in valsartan drug substances products in mid-2018 and highlights the regulatory response, sources of contamination and analytical methods used for identifying nitrosamines.
Examining Risk–Benefit Profiles for Vaccines content piece image
Article

Examining Risk–Benefit Profiles for Vaccines

In this article, David Elder, explores the risk–benefit profiles for various COVID-19 vaccines and discusses the steps taken by regulatory agencies in response to the occurrence of rare blood clotting events associated with the Oxford–AstraZeneca vaccine.
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