ISPE is to report on findings from the European Medicines Agency and European Federation of Pharmaceutical Industries and Associations Quality by Design Application workshop.
At the upcoming Strasbourg Conference on 28 September-1 October 2009 at the Palais des Congres, industry regulators and experts will be able to hear the latest news about the proposed ICH training programme from members of the ICH Implementation Working Group.
Attendees will also hear regulator and industry feedback from the previous day's EMEA/EFPIA workshop, where industry representatives will present case studies and exchange views on Quality By Design implementation with European assessors and European Union inspectors.
A summary of the EMEA/EFPIA workshop, as well as the lessons learned from the case studies, will be presented during ISPE's 'PQLI - Global Realisation and Implementation of the ICH Quality Vision' session in Strasbourg.
Attendees will also gain a greater understanding of Quality By Design's impact on the European pharmacopoeia and receive a status report on the progression of the Q11 guideline on Development and Manufacture of Drug Substances through EFPIA's Mock S2.
In addition, through a series of presentations and break-out sessions, attendees will discuss how ISPE's Product Quality Lifecycle Implementation (PQLI) initiative can assist in the application of Quality By Design to development and manufacturing, as well as how it can improve overall business performance.
In addition, ISPE and Interphex have organised a tabletop vendor exhibition and a variety of networking receptions that will allow exhibit attendees to engage and network with fellow seminar delegates, vendors, colleagues, and like-minded professionals from around the world.
Siemens is the recognised host sponsor of the conference, exhibition, and receptions.
