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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.

       

       

      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

               

               

              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

               

               

              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 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

                   

                   

                  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.