Other Event of Interest 11th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients - Regulatory Affairs Part - 22-24 October 2008 Paris, France Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: RA Part (EUR 1680,--) Book this option: ECA Members: RA Part (EUR 1596,--) Book this option: EU GMP Inspectorates: RA Part (EUR 1260,--) Book this option: APIC Members: RA Part (EUR 1512,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objective 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, EMEA, EDQM, WHO as well as Industry Experts will discuss the latest developments in the field of GMP and Regulatory Compliance. The GMP requirements for APIs are clearly defined, particularly in the ICH countries. However, the compliance levels established at the various API sites worldwide may differ considerably. The two most prominent Regulatory Authorities in the western world are using different approaches to oversee the quality of APIs. While in Europe the manufacturer of the medicinal product – and on his behalf the Qualified Person – needs to assure API-GMP compliance the US FDA rely on their own inspections of the API manufacturers’ sites. Both systems are currently trying to cope with the large and growing number of API manufacturers worldwide, part of which are appearing not to be in compliance with the interna-tional recognised standard ICH Q7 and/or with information submitted through registration dossiers. More and more information becomes available that both systems suffer from serious weaknesses. These developments do not only influence the level playing field in the API markets. More importantly, APIs not manufactured under compliant conditions raise substantial safety concerns regarding the medicinal products that contain them. The establishment of an efficient and effective system for the oversight and enforcement of API compliance will become the key issue for the years to come. The APIC/CEFIC Conference is the leading international forum for discussions on these important new developments. In addition, the conference will inform about the latest and to be expected regulatory developments by presentations of the major authority representatives. Moreover, 8 parallel sessions will provide the opportu-nity for an in-depth discussion of specific GMP and Regulatory Affairs topics.