Posted 16 August 2017
By Michael Mezher
The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.
The training programs are part of a pilot initiative agreed to at ICH's management committee meeting in Osaka, Japan in November 2016, where members of the management committee launched the year-long pilot and set out criteria for the program.
Under the pilot, the ICH Training Subcommittee has partnered with a small group of training providers to put together "high quality programs based upon the scientific and regulatory principles outlined in ICH guidelines."
The first of these ICH-endorsed training events, a workshop on chemistry, manufacturing and controls (CMC) quality, was held over three days in Singapore last March.
The upcoming training courses cover a range of topics, including regulatory submissions in the electronic common technical document (eCTD) format, good clinical practice (GCP) training and good manufacturing practice (GMP) for active pharmaceutical ingredients (APIs).
The topics for the training courses were selected based on the results of a survey given to industry and regulators to identify the areas where training is most needed.
Details for the courses are listed below, though a full program is not yet available for two of the events:
- Intermediate course for drug master file (DMF), active substance master file (ASMF), module 3 submissions in eCTD format – Frankfurt, Germany, 6-7 November 2017
- Intermediate course for regulatory submissions in eCTD format – San Diego, CA, 17-18 October 2017
- ICH GCP training – Cambridge, MA, 17-19 October 2017
- ICH Q1 stability training – Burlington, MA, 11-13 October 2017
- GMP for APIs (ICH Q7) training – Tokyo, Japan, 10-11 October 2017
Following the pilot, ICH says it will look into the outcomes of the training sessions to inform its decisions for a longer-term training strategy.