RAC DRUGS LATEST 2023 ALREADY PASSED (EU) MA Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA National, centralised, mutual recognition, decentralized procedures MAH A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? Active substance international non-proprietary name, trade name. SmPC Summary of Product Char...

Seven Core Competencies of the Lean Enterprise - Answer - Team and Technical Agility Agile Product Delivery Enterprise Solution Delivery Lean Portfolio Management Organizational Agility Continuous Learning Culture Lean Agile Leadership Spanning Palette - Answer - Not an artifact per se; rather, it comprises various roles and artifacts that may be applicable at any level of the framework. It is used to customize the framework implementation to a specific context. For a more complete disc...

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Seven Core Competencies of the Lean Enterprise - Team and Technical Agility Agile Product Delivery Enterprise Solution Delivery Lean Portfolio Management Organizational Agility Continuous Learning Culture Lean Agile Leadership Spanning Palette - Not an artifact per se; rather, it comprises various roles and artifacts that may be applicable at any level of the framework. It is used to customize the framework implementation to a specific context. For a more complete discussion, see ...

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SAFe SPC 5.0 Upgrade Exam EXAM LATEST ACTUAL EXAM QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES ANSWERS ALREADY GRADED A+ Seven Core Competencies of the Lean Enterprise - CORRECT ANSWERTeam and Technical Agility Agile Product Delivery Enterprise Solution Delivery Lean Portfolio Management Organizational Agility Continuous Learning Culture Lean Agile Leadership Spanning Palette - CORRECT ANSWER-Not an artifact per se; rather, it comprises various roles and artifacts that m...

What does an ART needs for its launch readiness? - 1. Define the ART 2. Set the launch date & cadence for the program calendar 3. Train ART leaders & stakeholders 4. Establish the Agile teams 5. Train product manager & product owners 6. Train the SM 7. Train the system architects/engineers 8. Assess and evolve launch readiness 9. Prepare the program backlog Benefit of timeboxing the preparation for the first PI planning event - Seeks to deliver the incremental value Ensures incremen...

Seven Core Competencies of the Lean Enterprise - ANSWER Team and Technical Agility Agile Product Delivery Enterprise Solution Delivery Lean Portfolio Management Organizational Agility Continuous Learning Culture Lean Agile Leadership Spanning Palette - ANSWER Not an artifact per se; rather, it comprises various roles and artifacts that may be applicable at any level of the framework. It is used to customize the framework implementation to a specific context. For a more complete discussi...