Document Type

Conference Paper

Rights

This item is available under a Creative Commons License for non-commercial use only

Disciplines

1.4 CHEMICAL SCIENCES, 3. MEDICAL AND HEALTH SCIENCES, 3.4 HEALTH BIOTECHNOLOGY

Publication Details

International Society of Pharmaceutical Engineers (ISPE) Frankfurt April 2011: Quality Risk Management conference

Abstract

This paper presents an Irish research study currently being undertaken by the Pharmaceutical Regulatory Science Team at the Dublin Institute of Technology (DIT) into the impact of new pharmaceutical regulatory guidance on the development and manufacture of medicinal drug products.

It launches a Pharmaceutical Industry Benchmarking Questionnaire designed to assess the impact and level of implementation of the ICH Tripartite Quality Guidance Q8, Q9 and Q10.

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