SADC HARMONIZATION INITIATIVES - ICH

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OUTLINE

• INTRODUCTION

• BRIEF HISTORY

• OBJECTIVES

• GUIDELINES DEVELOPMENT FOR MEDICINES

REGULATION

• PLAN OF ACTION

• TRAINING

• CHALLENGES

MedDRA DATA RETRIEVAL AND PRESENTATION: POINTS ... - ICH

Review of GCP: Goals, Principles, Roles and Responsibilities - ICH

OUTLINE • INTRODUCTION • BRIEF HISTORY • OBJECTIVES • GUIDELINES DEVELOPMENT FOR MEDICINES REGULATION • PLAN OF ACTION • TRAINING • CHALLENGES

INTRODUCTION • Regulatory challenges; • National Medicines Regulatory Authorities; • Legislative framework; • Technical Guidelines and requirements; • Human, physical and financial resources; • Process and systems;

Page 1: SADC HARMONIZATION INITIATIVES Tani
Page 5 and 6: BRIEF HISTORY • SADC Health Proto
Page 7 and 8: GUIDELINES DEVELOPMENT • Discussi
Page 9 and 10: PLAN OF ACTION • Two-years plan;
Page 11 and 12: Experience of Mozambique • New Le
Page 13: Thank You Obrigada

SADC HARMONIZATION INITIATIVES - ICH

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