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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.

       

       

      Marketing Authorisation in Russia, Ukraine and the Eurasian Economic Union

      Key topics:

            • Aims and timelines of the Eurasian Economic Union (EAEU)
            • Structure of legislative bodies and regulation outflow within the EAEU
            • Marketing authorisation of medicinal products in the EAEU
            • National registration in countries of the EAEU
            • Ukraine - similarities to EU procedures

            Please click here for detailed information on Marketing Authorisation in Russia, Ukraine and the Eurasian Economic Union.

             

             

            ASEAN & Chinese CTD/eCTD

            Key topics:

                    • ASEAN CTD and ICH CTD - differences you should know
                    • CMC, efficacy and safety - this data needs to be compiled
                    • Clinical trial application - the basis for a subsequent marketing authorisation
                    • eCTD and electronic submission - the status quo in the region

                    Please click here for detailed information on ASEAN & Chinese CTD/eCTD.

                     

                     

                    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

                       

                       

                      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

                       

                       

                      Iran, the Middle East and Turkey: Marketing Authorisation & Market Access

                      Key topics:

                      • Company registration and product export to Iran
                      • Registration of pharmaceuticals by the Iranian FDA
                      • GCC marketing authorisation - essential documents and approval process
                      • Access to the Turkish market: dossier, submission process and reimbursement

                      Please click here for detailed information on Iran, the Middle East and Turkey: Marketing Authorisation & Market Access

                       

                       

                      Biosimilars 2016

                      Key topics:

                        • Similarity, interchangeability and substitution
                        • Extrapolation in the clinical development
                        • Similarity of immunogenicity profiles
                        • Comparability versus similarity - CMC challenges
                        • Biosimilar safety profile & traceability

                        Please cklick here for detailed information on Biosimilars 2016