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Therapeutic Antibodies

From Originators...

  • Essential quality data for first-in-human clinical trials up to the marketing authorisation
  • Risk assessment and mitigation for first-in-human studies
  • Management of side effects & immunogenicity as a safety issue

...To Biosimilars

  • Quality: laying the foundation for biosimilarity
  • Update on progress of EU/US guidelines
  • Practical considerations on designing biosimilar clinical studies
  • Current regulatory thinking on extrapolation of indications

Please click here for detailed information on Therapeutic Antibodies.

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 the CIS Countries/Russia

    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

           

           

          Marketing Authorisation for human medicines in Latin America

          Focus: Brazil, Argentina, Colombia & Mexico

          Key topics:

          • Legal framework & national authorities
          • National marketing authorisation procedures
          • Dossier requirements in Latin America
          • Maintenance of the marketing authorisation

          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

           

           

          Marketing Authorisation in the Middle East

          Key Topics:

            • Market entry in the region - lucrative countries and regulatory strategy
            • New regulation regarding regulatory affairs and pharmacovigilance
            • Oman - interesting for your products?
            • GCC - necessary documents and approval process
            • Pharmacovigilance duties in the Middle East

            Please click here for detailed information on Marketing Authorisation in the Middle East

             

             

            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:

            • Marketing authorisation dossier requirements
            • Key persons in the countries
            • Communication with the national authorities
            • Maintenance and product information duties - variations and labelling

            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