- Key objectives of the revised legislation
- Provisions for marketing authorisations - just benefits?
- The future of product maintenance
- Extended data protection - a way to encourage innovation?
- Pharmacovigilance database - effective simplification?
Please click here for detailed information on Better Regulation for Veterinary Medicinal Products.
- Duties and competences of the MHLW and PMDA
- Regulatory requirements for clinical trials
- Details of the application dossier and the application procedure
- Variations and renewals - the Japanese system
Please click here for detailed information on Marketing Authorisation in JAPAN.
- Quality data for the dossier - the formats
- Pharmaceutical documentation for Latin America, Russia and Asia
- Country-specific requirements - import testing
- Global stability programmes
- CMC lifecycle management
Please click here for detailed information on Global CMC Requirements.
- Legal framework and national authorities
- National marketing authorisation procedures
- Dossier requirements - NCEs and generics
- Maintenance of the marketing authorisation
- Harmonisation trends in the LATAM region
Please click here for detailed information on Marketing authorisation in Latin America.
- Current regulatory framework in the Asian countries
- ASEAN: Harmonisation of the Asian drug market?
- China - guidelines and marketing authorisation
- Marketing authorisation for NCEs and generics
- Submission of variations and renewals
- Communication with the authorities
Please click here for detailed information on Marketing Authorisation in ASIA
- Documenting GMP compliance in the marketing authorisation
- GMP compliance verification - main sources of errors
- Workflow of change management processes
- Assurance of regulatory compliance
Please click here for detailed information on Regulatory Compliance & GMP Compliance
Regulatory Update - The Maghreb Countries & South Africa
- Dossier requirements
- Key people in these countries
- Communication with the national authorities
- Maintenance and product information duties - variations, labelling
- Tender business in the Maghreb region
Please click here for detailed information on Marketing authorisation in North & South Africa.
- Who follows the ICH or WHO principles?
- Submission strategy based on CPP?
- Role of affiliates, external consultants and agents
- Dossier, submission and maintenance duties
- Rolling out submissions
Please click here for detailed information on Marketing Authorisation Outside the ICH Region.