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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.

       

       

      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

               

               

              Generics and Biosimilars in MENA

              Key Topics:

                  • MENA, a good market for generics and biosimilars?
                  • The concept of supergenerics and biobetters
                  • Marketing authorisation documents and procedures
                  • Data protection in MENA - regulatory peculiarities for generics and biosimilars

                  Please click here for detailed information on Generics and Biosimilars in MENA

                   

                   

                  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.

                         

                         

                        The "e"-Challenges: The IDMP, XEVMPD and eSubmission

                        Key topics:

                          • E-only - when mandatory in the EU?
                          • Two years of CESP - lessons learnt
                          • Implementation of the ISO IDMP standards
                          • Impact of the IDMP on regulatory affairs and pharmacovigilance
                          • The XEVMPD - the aftermath of December 2014
                          • XEVMPD maintenance: simple change, major impact

                          Please click here for detailed information on The "e"-Challenges: The IDMP, XEVMPD and eSubmission.