level: MEMBERSHIP IN THE ASSEMBLY- ELIGIBILITY CRITERIA FOR REGULATORS
Questions and Answers List
level questions: MEMBERSHIP IN THE ASSEMBLY- ELIGIBILITY CRITERIA FOR REGULATORS
| Question | Answer |
|---|---|
| Engagement in the ICH Process (ELIGIBILITY CRITERIA FOR REGULATORS& INDUSTRY) | 1 Past regular attendance in ICH meetings 2 Past appointments of experts in WG |
| Application of ICH Guidelines | Tier 1 Q1: Stability Testing Guidelines G7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients E6: Good Clinical Practice Guideline |
| ELIGIBILITY CRITERIA FOR REGULATORS | 1 Engagement in the ICH Process 2 Application of ICH Guidelines |
| ELIGIBILITY CRITERIA FOR INDUSTRY | 1 Type of Organisation 2 Engagement in the ICH process 3 Impact of ICH Guidelines |
| Type of Organization (ELIGIBILITY CRITERIA FOR INDUSTRY) | International Pharmaceutical Industry Organisation IPIO |
| Impact of ICH Guidelines | The organisation & members must be regulated or affected by ICH guidelines |