Module 3 - Strategic case studies in practice

ICH Q12 Guideline

9 STABILITY DATA APPROACHES TO SUPPORT THE EVALUATION OF CMC CHANGES ..................................................................................................................... 21 10 GLOSSARY ................................................................................................................... 22 11 REFERENCES ............................................................................................................... 23 APPENDIX 1: CTD SECTIONS THAT CONTAIN ECS ................................................... 24 APPENDIX 2: PRINCIPLES OF CHANGE MANAGEMENT .......................................... 30

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