- Introduction to Global Regulatory Authorities for pharma and healthcare industries
- Drug Development Process
- Clinical Trials and related norms and regulations
- GMP
- Other good practices
- Documentation of drug trials and regulatory filings in:
- US, EU
- India, Japan, Canada
- Australia, South Africa, etc.
- Quality Assurance and Drug Regulations
- ICH and WHO guidelines
- Dossier preparation in CTD format
- eCTD submissions
- Healthcare Industry IPR
- Patents, copyrights and Trademarks
- Pharma and Healthcare products
- Marketing, Import and Export regulations
- Compliance guidelines
- Health authorityAudits (FDA, MHRA, PMDA, TGA, DCG, etc)
- Breach reports
- Industry specific case studies