Regulatory Roundup: International Conference on Harmonization Hosts a Series of New Training Sessions

Mar 31, 2011
By PharmTech Editors

The International Conference on Harmonization (ICH) is hosting a series of new training sessions this spring. A follow-up training program to the organizations ICH Q8, Q9, and Q10 Quality Implementation program will take place in Japan. The workshop will provide comprehensive information on the integrated quality-trio guidelines and is cosponsored by the Japan Pharmaceutical Manufacturers Association and the Pharmaceutical and Medical Device Regulatory Science Society of Japan.

In related news, the ICH Global Cooperation Group (GCG) endorsed the SADC training for regulators on the ICH Q7 guideline (GMP for APIs). The training is scheduled for this summer in Tanzania. GCC also endorsed ASEAN's request for training regulators and industry on the ICH Q5C guideline (quality of biotechnological products) and that training will take place this spring Kuala Lumpur. Finally, GCC endorsed a request for training on the ICH Q5 series of guidelines (Q5A - Q5E) on quality of biotechnological products, which will take place in spring 2011. Visit the ICH website for further details on these programs.