ICH Announces Training Program
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
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.
Source: ICH
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
