eClinical Technology and Industy News

Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits

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By Laurie Halloran, CEO & Chairwoman of the Board, Halloran Consulting Group, Inc.

While we have not yet seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on global health authorities is continuing to evolve. We expect a variety of potential delays in regulatory communication and meetings that will continue for months, if not years. In this article, we will review the impact current travel restrictions and the remote working environment are having on regulatory interactions, inspections, and audits, and we will conclude with a discussion of important technology and business continuity planning considerations related to the pandemic.

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