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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 in RUSSIA/the CIS Countries

            Key topics:

              • Current changes in the respective national drug laws
              • Structure and working procedures of the national authorities
              • The application dossier - format & content
              • The application procedure - timeframes & fees
              • Maintenance - renewals & variations

              Please click here for detailed information on Marketing Authorisation in the CIS Countries/Russia.

               

               

              Marketing Authorisation in the Balkan States

              Albania, Croatia, Montenegro, Macedonia, Bosnia & Herzegovina, Serbia and Kosovo

              Key topics:

              • Scope of the EU pharmaceutical legislation in practice
              • Marketing authorisation application in the Balkan States
              • Dossier content and CTD format
              • Communication with the national authorities
              • Maintenance - renewal & variations

              Please click here for detailed information on Marketing Authorisation in the Balkan States

               

               

              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.

                   

                   

                  MR & Decentralised Procedure - Your Regulatory Strategy

                  Key topics:

                    • Essential points in the presubmission phase
                    • The submission: country specialities!
                    • Multiple/duplicate applications - with case studies
                    • Delaying and accelerating factors
                    • E-Submission - eAF & CESP

                    Please cklick here for detailed information on MR & Decentralised Procedure - Your Regulatory Strategy