The history of drug development
The modern pharmaceutical industry : big and small pharma, biotechnology companies, and generic drug makers
Legal considerations, intellectual property, patents and patent protection
The global regulatory landscape
Phases of drug development : old and new paradigms
Discovery / preclinical
Phase I
Phase II
Phase III
Phase IV, special populations and post marketing commitments
Role and function of project teams
Compound progression and go / no go criteria
Regulatory milestones and the submission process
Life cycle management
Formulation development
Chemistry and manufacturing (CMC)
Health economics and the healthcare industry
Current state of affairs : attrition rates and evolving corporate strategies
Medical devices
Distribution and the supply chain
Sales, marketing and advertising
Generic drugs and the generic industry
The generic approval process
Data sharing and collaboration
The future of the pharmaceutical industry.