WHO/UNICEF Technical Briefing Seminar
on Essential Medicines Policies,
29 October - 2 November 2012,
World Health Organization Headquarters, Geneva.
Salle A
THURSDAY, 1 NOVEMBER 2012
Facilitation: Alain Prat EMP/QSM
Medicines Quality Assurance and Safety
09h00 - 10h00
Introduction to medicines quality assurance and safety
Lembit Rago, EMP/QSM
WHO normative functions in the field of pharmaceuticals
Sabine Kopp, EMP/QSM
11:00-11:15 Tea/Coffee break
Building regulatory capacity
11:15-12:30
Drug regulation: cooperation and harmonization
Samvel Azatyan, EMP/QSM and Alain Prat, EMP/QSM
12:30-14:00 Lunch
Prequalification of Medicines and Medical Devices
14:00-15:45
Introduction to Prequalification. Prequalification of Medicines Programme
Lembit Rago, EMP/QSM
API prequalification
Antony Fake, EMP/QSM
QC lab prequalification update
Jitka Sabartova, EMP/QSM
Training & capacity building update
Smid Milan, EMP/QSM
Prequalification of Diagnostics and Medical Devices
Gaby Vercauteren, EMP/DLT
Anita Sands, EMP/DLT
15:45-16:00 Tea/Coffee break
16:00-17:00
Quality assurance for blood products and related biologicals
Dr Ana Padilla, EMP/QSM