CITI Training Practice Exam

Who nominates nonvoting participants to attend ICH steering Committee meetings?

1. The ICH member organizations

2. The observer groups (WHO, Health Canada, and EFTA)

3. The United Nations

4. The European Union

The correct answer is: The observer groups (WHO, Health Canada, and EFTA)

While all of these entities may be involved in the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) steering committee meetings, the observer groups are the ones responsible for nominating nonvoting participants. This is because the observer groups, which include the World Health Organization (WHO), Health Canada, and the European Free Trade Association (EFTA), hold observer status within the ICH and play a role in providing feedback and exchanging information with the ICH's member organizations. On the other hand, the United Nations and the European Union do not hold observer status within the ICH and therefore do not have the authority to nominate nonvoting participants for these meetings.