[Brief Introduction of Seminar]1. In this session the importance of having CEPs for global registrations will be discussed. More and more, countries around the globe are fully or partly recognizing the CEP, which significantly increases the usefulness of the CEP for use also outside of the EU.
2. In this session focus will be on the different requirements around the globe for the regulatory API information. The comparison will include the major markets around the world.
[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 a trainer for the European Compliance Academy in a number of API regulatory oriented trainings.