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King Fahd Palace Hotel

Apr 27, 2015 7:00 AM - Apr 28, 2015 6:30 PM

Pointe des Almadies, Dakar, B.P. 8181, Senegal

4th African Regulatory Conference

Session 7: Plenary - Optimised Dossier Review Process; Room BC12

Session Chair(s)

Vincent I. Ahonkhai, MD, FAAFP

Vincent I. Ahonkhai, MD, FAAFP

Senior Advisor, Global Health

Bill & Melinda Gates Foundation, United States

Corneille  Traore

Corneille Traore

Director

West African Economic and Monetary Union (UEMOA) , Burkina Faso

Milan  Smid, MD, PhD

Milan Smid, MD, PhD

Department of Essential Medicines and Health Products (EMP)

World Health Organization (WHO), Switzerland

Chairs: Vincent I. Ahonkhai and Corneille Traore
Moderator: Milan Smid

Dossier review processes in different African countries are evolving over time and new registration requirements are being implemented. Variety and differences in requirements have led to increased review timelines and prolonged access for patients to medicines. This session targets to evaluate possibilities to optimise dossier review processes in different African regions and countries. Input will be brought in from the European Union where collaboration between countries has evolved and led to a harmonised approach and work-sharing between countries. The current situation in Africa will be analysed and recommendations be given how to improve processes, and show possibilities for harmonisation and collaboration between African countries.

Speaker(s)

Margareth  Ndomondo-Sigonda

Optimised Dossier Review Process. Continental Approach

Margareth Ndomondo-Sigonda

African Union-New Partnership, Africa's Development (NEPAD), South Africa

Head of Health Programs

Hiiti  Sillo, MSc, RPh

Optimized Dossier Review: East African Community Perspectives

Hiiti Sillo, MSc, RPh

World Health Organization (WHO), Switzerland

Unit Head, Regulation and Safety, Department of Regulation and Prequalification

Amadou Moctar  Dieye

COMMENT OPTIMISER LE PROCESSSUS D’EVALUATION DES DOSSIERS D’HOMOLOGATION EN AFRIQUE:CAS DE L’UEMOA

Amadou Moctar Dieye

Direction de la Pharmacie et du Medicament, Senegal

Director

Milan  Smid, MD, PhD

Models of collaboration and work-sharing in optimization of dossier review process

Milan Smid, MD, PhD

World Health Organization (WHO), Switzerland

Department of Essential Medicines and Health Products (EMP)

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