Clinical Development Risks and Issues in a COVID-19 World

Posted by Jonathan Rowe on Fri, Mar 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).


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What China’s Latest Drug Negotiations Mean for Global Pharma Companies

Posted by Crystal Lam on Wed, Jan 22, 2020

Sonia Yan and Daniel Blessing co-authored this blog post with Crystal Lam.

China’s National Healthcare Security Administration (NHSA) recently released the outcomes of its 2019 National Reimbursed Drug List (NRDL) negotiations: 70 of 119 new therapies were successfully listed. This record outcome more than doubled the number of therapies reimbursed through China’s negotiation pathway, which was formally implemented in 2017.


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