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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.

           

           

          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

                   

                   

                  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.