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.

This year, like the last, is a special year and will certainly be remembered. Therefore the APIC Steering Committee has decided once more to offer the APIC/CEFIC Global GMP & Regulatory API Conference as an on-site and online event. The lectures will be held live in Berlin and streamed online so that you may choose freely how you wish to participate.

The first day of the Conference provides updates from recent authorities’ initiatives, activities and interpretations like the update of HPRA about latest Brexit activities, FDA’s Quality Management Maturity Program, EMA’s outlook for the API industry and the European Union’s position on reshoring of APIs. Hear from industry speakers their approaches and best practices on all API related topics.

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

The second day of the Conference provides, besides three Parallel Sessions with various GMP and RA topics, updates about EDQM’s and ANVISA’s activities and PMDA’s  inspection procedures.

The API world is changing rapidly. The third day's focus will be on the impact of these changes on API companies.