SADC HARMONIZATION INITIATIVES - ICH

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TRAINING PROGRAMME

• Evaluation of application dossiers for

medicines authorisation;

• Qualification and accreditation of QA/QC

laboratories;

• Development and implementation of Quality

Management Systems (QMS);

• Market surveillance and monitoring.

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

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

TRAINING PROGRAMME • Evaluation of application dossiers for medicines authorisation; • Qualification and accreditation of QA/QC laboratories; • Development and implementation of Quality Management Systems (QMS); • Market surveillance and monitoring.

Experience of Mozambique • New Legislation, Regulation and Procedures that came up; • Approval of an independent and autonomous NRA; • External evaluation of the implementation of a roadmap; sector and • Sharing expertise within the region; • Development of tools in order to improve the availability of good quality and efficacious medicines.

Page 1 and 2: SADC HARMONIZATION INITIATIVES Tani
Page 3 and 4: INTRODUCTION • Regulatory challen
Page 5 and 6: BRIEF HISTORY • SADC Health Proto
Page 7 and 8: GUIDELINES DEVELOPMENT • Discussi
Page 9: PLAN OF ACTION • Two-years plan;
Page 13: Thank You Obrigada

SADC HARMONIZATION INITIATIVES - ICH

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