19th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
23 - 25 November 2016
Objectives of the Conference
The APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from FDA, 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.
The conference will be opened by a presentation about how to manage an effective Quality Management system followed by a presentation about the Qualified Person’s role on ensuring GMP compliant APIs. The following lectures are dedicated to the consequences arising from non GMP compliant manufacture of APIs, the FDA’s Quality Metrics program, quality risk management in global API supply chains and data integrity issues.
In the Joint GMP and Regulatory Affairs part of the conference you will hear presentations about the ICH Q11 regulatory starting materials Q&A, the new ICH Q12 guideline and its Impact on post approval changes, the interrelationship between GMP and Regulatory Affairs and an update on EDQM’s activities.
The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to quality aspects of starting materials, GMP compliant API facility design and data integrity issues as well as current regulatory hurdles, practical experiences concerning GDUFA and ICH Q3D in connection with API manufacturers’ responsibilities.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.