The kick-off meeting
Job profiles, professions, and departments
New drug development and launches
Cultural differences in marketing drugs and medicine
Substance discovery and product development
A new chemical entity (NCE)
Drug dosage forms
Categories of drugs
Quality assurance and auditing
Good pharmaceutical industry practice (GxP)
Quality assurance audits
Laboratory safety systems
Standard operating procedures
Ready for testing in live organisms
Preclinical testing
Clinical testing
Dealing with authorities
Experimental drugs on trial
Drug safety and regulatory affairs
Pharmacovigilance
Regulatory documentation
Patient information
Counterfeit medicines
Production and packaging
Safety requirements
Production processes
Packaging challenges
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