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Phase 3 Clinical trials (Operational issues (CRO's, Cost, Multi centre…
Phase 3 Clinical trials
History of regulation and GCP
GCP outline
Structure of EMA and clinical trials
US and EU
Clinical trial Directive
2001/20/EC
Pros and cons
2001/83/EC
quality,safety and efficacy
EU No 536/2014
Pros and cons
Operational issues
CRO's
Cost
Multi centre
Trial design
Strategic issues
Adaptive trials
Examples from industry