Objectives of the Conference

The APIC/CEFIC Global GMP & Regulatory API Conference is Europe’s leading API event. Many major stakeholders from Authorities and the Industry are joining this Conference each year. Speakers from EMA, EDQM, FDA, National Authorities, the Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.

The GMP part of the Conference, of which the final module is a Joint GMP & RA session, provides updates from recent authorities’ initiatives, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers about their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.

After several regulatory topics will have been presented during the second conference day, the RA part of the conference will highlight key aspects of registration procedures in Saudi Arabia and Korea as well as, aspects of future ASMF assessment and CEP modernisation.

The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.