MHRA/EMEA Sharing Their Expertise at IQPC’s PAT & Quality by Design Event
The MHRA and EMEA have just confirmed that Des Makohon, Senior GMP Inspector, MHRA and Member, PAT Team, EMEA will be part of the speaker panel at IQPC's 7th Annual PAT & Quality by Design event, taking place January 19-20 in London.
London, United Kingdom, December 03, 2009 --(PR.com)-- http://www.patandqbd.com/Event.aspx?id=217042&utm_source=PR.COM&utm_medium=pressrelease&utm_campaign=PR.COM&utm_content=12_1_2009&mac=11287.004PR
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.
http://www.patandqbd.com/Event.aspx?id=217042&utm_source=PR.COM&utm_medium=pressrelease&utm_campaign=PR.COM&utm_content=12_1_2009&mac=11287.004PR
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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.
http://www.patandqbd.com/Event.aspx?id=217042&utm_source=PR.COM&utm_medium=pressrelease&utm_campaign=PR.COM&utm_content=12_1_2009&mac=11287.004PR
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IQPC
Jagruti Lachhani
+44 (0)20 7368 9300
http://www.patandqbd.com/Event.aspx?id=217042&utm_source=PR.COM&utm_medium=pressrelease&utm_campaign
Jagruti Lachhani
+44 (0)20 7368 9300
http://www.patandqbd.com/Event.aspx?id=217042&utm_source=PR.COM&utm_medium=pressrelease&utm_campaign
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