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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.

       

       

      Phytopharmaceuticals: Regulatory Affairs in Eastern Europe/Russia & China

      Key topics:

          • Get an in-depth insight into the role of phytopharmaceuticals in the different healthcare systems
          • Understand the various marketing authorisation procedures and the current challenges
          • Get an update on the legislative changes in the regions
          • Get practical hints for your product maintenance

          Please click here for detailed information on Phytopharmaceuticals: Regulatory Affairs in Eastern Europe/Russia & China.

           

           

          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.

                 

                 

                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