SADC HARMONIZATION INITIATIVES - ICH

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OBJECTIVES

• Promotion of access to essential medicines of

quality, safety and efficacy by:

* Development of standards for the quality,

safety and efficacy of medicines in the region;

*Establishment of a structure for

harmonisation;

*Establishment of centre of excellence.

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

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

OBJECTIVES • Promotion of access to essential medicines of quality, safety and efficacy by: * Development of standards for the quality, safety and efficacy of medicines in the region; *Establishment of a structure for harmonisation; *Establishment of centre of excellence.

GUIDELINES DEVELOPMENT • Discussion forums • Represantation • Allocation of responsabilities • Process and Progress (17 guidelines approved and 5 outstanding)

Page 1 and 2: SADC HARMONIZATION INITIATIVES Tani
Page 3 and 4: INTRODUCTION • Regulatory challen
Page 5: BRIEF HISTORY • SADC Health Proto
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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