317E


| 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 |
[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.