ICH Updates: What’s coming in 2019 and beyond

30-04-2019

ICH Updates: What’s coming in 2019 and beyond

(Source: RAPS 2019-05-01)

US Food and Drug Administration (FDA) officials on Monday morning held a meeting to offer a rundown of what needs to be done and what to expect from more than a dozen different International Council for Harmonisation (ICH) guidelines.

Kicking off the three-hour meeting, hosted alongside Health Canada, three FDA experts and Lisa LaVange, professor of biostatistics at the University of North Carolina, discussed topics that recently reached Step 3 of the ICH process. The ICH Assembly’s next two meetings are in Amsterdam in June and Singapore in November.

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