19 - 20 January, 2010, Grand Connaught Rooms, London, UK
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A Review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry by: James Munson, C. Freeman Stanfield and Bir Gujral
Monte Carlo Simulations For Risk Analysis In Pharmaceutical Product Design By: Bir Gujral
7th Annual PAT and Quality by Design - Article
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Pharma IQ is delighted to announce the dates for the 7th Annual PAT and Quality by Design forum taking place in London on the 19th-20th January 2010. 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.
This 7th Annual event has seen over 400 attendees travelling from approximately 20 countries in its years since conception and consistently 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.
KEYNOTE SPEAKER
Dr Victor A. VinciDirector, Bioprocess OperationsEli Lilly and Company
Des Makohon Senior GMP Inspector, MHRA. Member, PAT Team EMEA
Michael SchousboeExpert, Manufacturing Science and Quality Novo Nordisk
Zadeo Cimarosti Manager, Chemical Development GlaxoSmithKline Verona Italy
Philippe Cappuyns Pharmaceutical Technology Director Janssen Pharmaceutica
Uncover first hand how to apply PAT and QbD to Biopharmaceuticals: Eli Lilly and Company will be sharing the results from a consortium project based on the development of a monoclonal antibody using QbD. With a number of companies involved with the project as well as the FDA this can’t fail to provide a valuable learning experience for all!
Discuss best practice in optimising commercial product margins through PAT and QbD principles from early development onwards: Novartis will also be delivering a very unique insight in the application of QbD/PAT on a commercial product.
Overcome the challenges regulations constantly pose: Bristol Myers Squibb will be discussing the product saxagliptin (trade name Onglyza), and the trials and tribulations faced during regulatory submissions with a number of different regulatory bodies as well as the lessons they learnt.
Establishing a successful change management strategy when implementing QbD across the whole business: Novo Nordisk discuss their strategy and how it’s helping them create a smoother transition
How to capture and manipulate real time data efficiently to support your PAT/QbD initiatives: Vertex Pharmaceuticals share their recent experiences and show you get the most out of your data
There were some excellent presentations
Very valuable.
Very good. Good update and information on current state of QbD & PAT. A good general overview of what design space is to pharma
Valuable in the sense that it brought some new insights, some nice to know elements & some new colleagues in the industry.
Really enjoyed the case examples when a good level of detail was presented. Has been very useful to understand current status as perceived by industry & network with colleagues.
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