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RUSSIA: Registration of Generics and Biosimilars

Key topics:

    • Legal background for a generic registration
    • Current challenges in biosimilar registrations
    • Dossier and registration process
    • Local bioequivalence studies according to the new Russian guidelines

     Please click here for detailed information on RUSSIA: Registration of Generics and Biosimilars

     

     

    FDA: Marketing Authorisation in the U.S.

    Key topics:

      • US FDA regulations in comparison with the EU law
      • The FDA drug registration in detail
      • Communication with the FDA
      • Marketing authorisation granted - the arising duties
      • Case Study - how FDA approves oncological products

       Please click here for detailed information on FDA: Marketing Authorisation in the U.S.

       

       

      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.

         

         

        Regulatory Affairs India

        Key topics:

          • The authorities' system
          • New drug registration regulation
          • Generics drug registration
          • Post-approval regulatory processes

          Please click here for detailed information on Regulatory Affairs India.

           

           

          Regulatory Affairs China

          Key topics:

            • The CFDA and further authorities, agencies & ministries
            • Documents for the application
            • Maintenance of the licence
            • IP protection

            Please click here for detailed information on Regulatory Affairs China.

             

             

            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

             

             

            Scientific Writing and Reviewing in Regulatory Affairs

            Key Topics:

            • Free writing versus regulatory restrictions
            • Writing and reviewing regulatory documents
            • Editing and proofreading documents
            • Package leaflet - regulatory linguistic restrictions and user-friendly writing
            • Good writing skills - example: clinical overviews and summaries

            Please click here for detailed information on Scientific Writing and Reviewing in Regulatory Affairs

             

             

            Marketing Authorisation in Turkey and the CAC Countries

            Key topics:

              • Access to the local markets - preconditions for companies
              • Application dossier requirements
              • Further obligations: GMP, clinical trials and vigilance
              • Application procedures for NCEs, generics, biosimilars ...
              • Maintenance duties - renewals and variations

              Please click here for detailed information on Marketing Authorisation in Turkey and the CAC Countries.

              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

                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.