CYCLING
April st 1
Product life-cycle Ministries (country) Int'l Organisations Funding agencies WHO (international) Ministries (country) Pharma Regulators
R&D
Registration
Effects on health ? Practice
Adoption by country Procurement Distribution/scale-up
Policies Essential Drug List Marketing Production
Health systems Private sector Researchers
New indication Label changes
Post-regulatory Research "phase IV" Operational research Surveillance Pharmacovigilance
Public & Private sector Pharma/PPP
Pick one (or more) • Various drugs available –Most 'me-too' BUT all product not equal • Elements of choice: –Efficacy AND Safety Å trials –Quality Å CMC, in-vitro & vivo bioavailability –Cost, ease (simple/accurate), shelf-life • Summarising (& rating) evidence: RCTs… • Informing policy; simplify message • Procurement mechanisms & criteria