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level: MEMBERSHIP IN THE ASSEMBLY- ELIGIBILITY CRITERIA FOR REGULATORS

Questions and Answers List

level questions: MEMBERSHIP IN THE ASSEMBLY- ELIGIBILITY CRITERIA FOR REGULATORS

QuestionAnswer
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 GuidelinesTier 1 Q1: Stability Testing Guidelines G7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients E6: Good Clinical Practice Guideline
ELIGIBILITY CRITERIA FOR REGULATORS1 Engagement in the ICH Process 2 Application of ICH Guidelines
ELIGIBILITY CRITERIA FOR INDUSTRY1 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 GuidelinesThe organisation & members must be regulated or affected by ICH guidelines