Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
|Articles|August 14, 2017
ICH Announces Training Program
Author(s)BioPharm International Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
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On August 14, 2017, the International Council for Harmonization (ICH) announced a training pilot program that will partner its Training Subcommittee with a group of trainers to provide instruction on ICH scientific and regulatory principles. ICH will evaluate the pilot program at the end of 2017 to determine a longer-term training strategy
The committee performed a needs assessment survey to determine which guidelines needed training. The following training will be provided:
- Intermediate Course for DMF, ASMF, Module 3 Submissions in eCTD Format, Frankfurt, Germany, Nov. 6–7, 2017. ICH will provide more information in the future.
- Intermediate Course for Regulatory Submissions in eCTD Format, San Diego, CA, USA, Oct. 17–18, 2017. ICH will provide more information in the future.
- ICH GCP Training, Cambridge, MA, USA, Oct. 17–19, 2017. The workshop, which will be taught by members of FDA, the European Medicines Agency, and Health Canada, will advance understanding of ICH E6 and the revised E6(R2) guidelines. Information about the program can be found on the
ICH website .
- ICH Q1 Stability Training, Burlington, MA, USA, Oct. 11–13, 2017. The training will help participants understand expectations regarding stability testing. Information about the program can be found on the ICH
website .
- GMP for APIs (ICH Q7) Training, Tokyo, Japan - October 10-11, 2017. This course, run by Japan’s Pharmaceuticals and Medical Devices Agency and the Parenteral Drug Association, will offer insights from GMP inspectors and the requirements of ICH Q7. Information about the program can be found on the ICH
website .
ICH-endorsed programs will include the ICH logo.
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