London, United Kingdom, December 03, 2009 --(PR.com
Mr Makohon will be providing an EU Regulatory Perspective of PAT Technology and Inspections as well as answering the individual questions of those pharmaceutical manufacturers present in the delegate audience of IQPC'S conference. As a counterpoint to this presentation Bristol Myers Squibb will be discussing their learnings from the launch of the product saxagliptin (trade name Onglyza), and the challenges faced during regulatory submissions with a number of different regulatory bodies.
The application of PAT and QbD to Biopharmaceuticals will be covered by Eli Lilly, who will be sharing the results from a consortium project based on the development of a monoclonal antibody using QbD. There are a number of companies involved with the project as well as the FDA.
Later in the programme, Novartis are to discuss the best practices in optimising commercial product margins through PAT and QbD principles from early development onwards whilst Novo Nordisk present their change management strategy and Vertex Pharmaceuticals share their recent experiences of data manipulation and analysis.
The annual event has seen over 400 attendees travelling from approximately 20 countries in the years since its conception and provides a forum for both PAT and Quality by Design professionals to discuss pressing topics and new initiatives taking hold within the area, as well as network with new people and increase their contact base. PAT and Quality by Design is one area within the pharmaceutical industry that constantly sees exciting developments and with the occurrence of the FDA pilot, this year is no exception.