Open Access. Powered by Scholars. Published by Universities.®

Chemistry Commons

Open Access. Powered by Scholars. Published by Universities.®

Medicinal-Pharmaceutical Chemistry

PDF

2023

Quality Risk Management

Articles 1 - 2 of 2

Full-Text Articles in Chemistry

Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle, Michael Schousboe Dec 2023

Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle, Michael Schousboe

Level 3

This article is based on a presentation given at the event ICH Q9(R1): The Next Frontier hosted by TU Dublin, Grangegorman 01-June-2023

An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient


Achieving Warranted Acceptance Of Biotechnologies, Emily Grayek, Baruch Fischhoff Dec 2023

Achieving Warranted Acceptance Of Biotechnologies, Emily Grayek, Baruch Fischhoff

Level 3

The U.S. has faced long-standing shortages of generic drugs, causing negative health effects and spikes in drug costs. To address these shortages, investments in critical technologies and policies to support their adoption will be needed. The success of these technologies and policies depends on public acceptance. We studied public acceptance using the mental model approach, which identifies gaps in understanding that can be addressed with communications. We began with semi-structured interviews with experts in pharmaceutical manufacturing. Based on these interviews, we developed and conducted surveys of the general public, physicians, and pharmacists. Similar strategies could be applied to improve communications …