Objectives of the Conference

The 23rd Global GMP & Regulatory API Conference is Europe’s largest event focussed on active pharmaceutical ingredients. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.

The GMP Conference, of which the final part 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 their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.

In the Joint GMP and the Regulatory Affairs part of the conference you will learn about API Filing in South Korea, Risk based approach to supplier management, CEP modernisation, Practical application of operational excellence and much more.

The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate, inter alia, to API registration in Brazil, Quality culture, APIC´s Experience with API Registrations in China and ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products.

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