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The International Council for Harmonisation (ICH) met in Singapore from 16 – 20 November 2019, bringing together over 450 participants from ICH’s sixteen Members and thirty-two Observers.
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.
In October 2018, further to a discrepancy raised regarding the Permissible Daily Exposure (PDE) for ethyleneglycol, an error correction procedure was launched. In October 2019 the PDE was reinstated to its previous value (Q3C(R6)).
The ICH E17 Guideline on General Principles for Planning and Design of Multi-Regional Clinical Trials was finalised under Step 4 in November 2017. An extensive set of training materials including 7 modules has been developed.
ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials” to solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8(R1) Guideline.
ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials” to solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8(R1) Guideline.
In June 2019, the ICH Assembly met in Amsterdam, the Netherlands for its bi-annual meeting. To ensure transparency in the ICH process, minutes from this meeting are made publicly available.
ICH is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials”, to be held on October 31, 2019 in Silver Spring, Maryland, USA, with Webcast option available.