Showing XXX results across 3 categories.
The MedDRA Management Committee noted that 1 March 2019 will mark the 20 year anniversary of the first release of MedDRA.
The ICH Q3C(R7) Guideline, the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in ICH Q3C(R6), and the Q3C Support Documents 1, 2 and 3 are now available on the ICH website.
The ICH S11 draft Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Medicines reached Step 2b of the ICH Process in September 2018.
The ICH M9 draft Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and has entered the public consultation period.
The ICH E9(R1) Step 2 Training Material was produced by the ICH E9(R1) Expert Working Group to accompany the Draft ICH E9(R1) Addendum.
The ICH Q3D(R1) Revision to the Q3D Cadmium Inhalation PDE reached Step 2b of the ICH Process in May 2018.
In June 2018, the ICH Assembly and Management Committee met in Kobe, Japan for their bi-annual meeting.
At its meeting in Kobe, Japan in June 2018, the ICH Assembly approved the 2017 Annual Report of the ICH Association.