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Biosimilars FORUM

Key topics:

    • Comparability exercise - the reference as a "moving target"
    • Quality issues: quality target product profile
    • Clinical testing: bioequivalence, immunogenicity
    • Sourcing of originator medication
    • Biosimilars: guidelines, current regulatory thinking and health economy

    Please click here for detailed information on BiosimilarsFORUM.

     

     

    Marketing Authorisation in JAPAN

    Key topics:

      • Duties and competences of the MHLW and PMDA
      • Regulatory requirements for clinical trials
      • Details of the application dossier and the application procedure
      • Variations and renewals - the Japanese system

      Please click here for detailed information on Marketing Authorisation in JAPAN.

       

       

      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.

         

         

        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 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.

         

         

        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