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 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 EMA’s current activities in 2019 followed by a presentation about non sterile APIs used in sterile drug products. The following lectures are dedicated to the Supply chain security for APIs, Anti-counterfeiting activities in Europe, relevant aspects of risk based assessment of indirect materials and qualification of suppliers and how to deal with avoidable and unavoidable particles in APIs.
In the Joint GMP and the Regulatory Affairs part of the conference you will get to know about FDA’s current practice of DMF assessment, the consequences of Brexit for APIs, how to prepare pre-approval inspections and an update on Ph.Eur. and CEP procedures.
The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to Data Integrity risk assessments, practical experiences with API filings in Emerging Countries, biological extraction products, regulatory hurdles and opportunities, feedback on the 2nd revision of ICH M7 Q&A and GMPs for manufacture of clinical trial material from a CMO’s perspective.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.