Medicines

WHO Technical Briefing Seminar
on Essential Medicines and Health Products,
28 October - 1 November 2013,
World Health Organization Headquarters, Geneva.
Salle M 505



THURSDAY, 31 OCTOBER 2013

09h00 - 09h30
Introduction to regulation of medicines and health technologies
Lembit Rägo, EMP/RHT


Technologies, Standards and Norms

09h30 - 10h30
WHO normative functions in the field of pharmaceuticals
Sabine Kopp, EMP/TSN (30 min)
Ivana Knezevic, EMP/TSN vaccines and biotherapeutic products (20 min)


10:30-11:00 Tea/Coffee break


11:00-11:45
Quality assurance for blood products and related biologicals
Ana Padilla, EMP/TSN


Building regulatory capacity

11:00-11:45
Drug regulation: cooperation and harmonization
Alain Prat, Alireza Khadem and Claudia Alfonso EMP/RSS


13:00-14:00 Lunch break



Prequalification of Medical Products

14:00-15:45
Prequalification of Medical Products
Lembit Rägo, EMP/RHT (20 min)

Prequalification of Medicines and Vaccines
Deusdedit Mubangizi, Carmen Rodriguez EMP/PQT (40 min)

Prequalification of Diagnostics and Medical Devices
Mercedes Pérez González, EMP/PQT (20 min)


15:45-16:15 Tea/Coffee break


16:15-17:00
Capacity building and technical assistance for national regulators and industry
Milan Smid, EMP/PQT TBC and Alireza Khadem and Claudia Alfonso EMP/RSS


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