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Better Regulation for Veterinary Medicinal Products

Key topics:

      • 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.

       

       

      Marketing Authorisation in JAPAN

      Key topics:

        • 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.

         

         

        Global CMC Requirements

        Key topics:

            • 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.

             

             

            Marketing Authorisation for Human Medicines in Latin America

            Key topics:

              • 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.

               

               

              Marketing Authorisation in ASIA

              Key Topics:

              • 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

               

               

              Regulatory Compliance & GMP Compliance

              Key Topics:

              • 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

               

               

              Marketing authorisation in North & South Africa

              Regulatory Update - The Maghreb Countries & South Africa

              Key topics:

                • 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.

                 

                 

                Marketing Authorisation Outside the ICH Region

                Key topics:

                  • 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.