• Beyond Skin Boosters: ECM-Driven Innovative Biomaterials for Aesthetic Injectables 2026.08.25 (13:00 - 13:30) | Hall C Seminar room Bloomage Biotechnology Corp., Ltd. Dion Kim, Sales Director Detail View
  • A gap analysis between regulatory requirements on post approval changes in the global environment. / Post approval API changes: practical examples 2026.08.27 (10:00 - 12:00) | 3F Conference Room 317 MARA Consultancy Marieke van Dalen, global regulatory specialist Detail View
  • 317E

    닫기

    Title A gap analysis between regulatory requirements on post approval changes in the global environment. / Post approval API changes: practical examples
    Date 2026.08.27 (10:00 - 12:00) | 3F Conference Room 317
    Organization MARA Consultancy
    Speaker Marieke van Dalen, global regulatory specialist
    Speaker & Lecture Information

    [Brief Introduction of Seminar]

    An overview will be presented on the different requirements around the globe for the introduction of API related changes. The comparison will include the major markets around the world.

    For some often-occurring API related changes, it will be shown what the regulatory requirements and timelines are. It will become clear that this is an issue that needs further global harmonization. 

     

    [Brief Introduction of Speaker]

    Marieke van Dalen studied chemical technology.

    She leads her own consultancy in the Netherlands after 38 years of experience in the API industry, always in the regulatory field. Her latest position in industry was with Aspen API in the Netherlands.

    She was a Board member of APIC (the European API organization) and represented APIC often in meetings with Health Authorities all around the world.

    She chaired the Regulatory Affairs workgroup of APIC for some years and later on co-chaired the Japan and EDQM task forces.

    Marieke is today also a trainer for the European Compliance Academy in a number of API regulatory oriented trainings.​ 

  • The King of Ayurveda ; KSM-66 Ashwagandha with the proven science and how people would benefit from its health supplements formats 2026.08.25 (10:20 - 11:20) | 3F Conference Room 317 Kolmar BNH SungJin Lee, Team Leader Detail View