ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10
Don’t miss these “must attend” events for industry and regulatory personnel.
| Europe |
2-4 June 2010 |
Tallinn, Estonia |
| USA |
6-8 October 2010 |
Washington, DC |
| Japan |
25-27 October 2010 |
Tokyo |
Workshop Content
Practical training on integrated implementation of Q8, Q9 and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and GMP-inspection. This is an opportunity for open dialogue among industry and regulators on:
- Comprehensive training on regulatory aspects, technical development and manufacturing
- Case study combining Q8, Q9 and Q10
- Regulatory topics related to submission expectations and GMP-inspections
Faculty
Regulator and Industry experts serving the ICH Q-IWG and experts involved in development of the ICH Q8, Q9 and Q10 guidances.
Who should attend
Workshops are open to all persons having interest in practical implementation of ICH Q8, Q9 and Q10, including regulators (assessors and GMP-inspectors) and industry (all disciplines).
Workshop Feedback
Information from the workshops will be used by ICH Q-IWG to support the harmonised implementation of ICH Q8, Q9 and Q10. Workshop materials are suitable for internal training by industry and regulators.
International Conference on Harmonization (ICH), guidances on Pharmaceutical Development (Q8), Quality Risk Management (Q9), and Pharmaceutical Quality System (Q10).
www.ICH.org
European and USA events are co-sponsored by ISPE and PDA on behalf of the International
Conference on Harmonization.
