PREVIEW SHOW
Date 20 – 22 February 2012
Venue Thistle Marble Arch, London, UK
THE LATEST PAT AND QbD AGENDA
The longest running European event devoted to cutting costs, increasing efficiency and improving quality through best practice PAT and QbD implementation, Pharma IQ once again opens its doors to industry specialists from the PAT and QbD community and creates an opportunity to learn from leading minds in the industry, increase understanding in companies and cut costs and increase efficiency by learning the best practice approaches to implementing PAT and QbD at the 9th Annual PAT and QbD conference between 20 – 22 February, 2012, Thistle Marble Arch, London, UK.
PAT and QbD remains a field that still lacks clarity and commonality in understanding. In a recent industry-survey released by Pharma IQ across the PAT and QbD community it was found that 53 per cent of end users said the key reason they were not implementing PAT/QbD was due to a lack of personnel with expertise in the field. The 9th annual PAT and QbD conference
agenda includes a number of regulatory orientated talks, opportunities to speak directly with regulators during interactive panel discussions and a fantastic panel of speakers with perspectives offered by three regulatory bodies. Speaker Nuno Matos, PAT Specialist from
Hovione mentioned: “I look forward to discussing the role of the CMO in the integration of QbD/PAT methodologies across the drug substance and drug product supply chain during development and commercial manufacturing.”
Among the key topics the event will discuss: Key current regulatory updates, including the release of ICH Q11, and how to best interpret regulatory guidance
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European Pharmaceutical Review Volume 16 | Issue 6 | 2011
“Establishing the correct QbD strategies and tools early in the development process is key to ensuring we have robust quality products downstream ”
Best practice approaches to writing regulatory submissions
The practical advantages of PAT and QbD implementation and how to maximise the financial benefits
How PAT and QbD can be implemented from research and development through to manufacturing
Developing design spaces and overcoming the challenges presented along the way
Best practice approach to, and realising the benefits of, identifying your Target Product Profile from the offset
How best to overcome the challenges of implementing PAT for biologics
Assessing the framework for Quality Risk Management
Making a business case for PAT and QbD implementation: the podcast In an interview podcast, 9th Annual PAT and QbD speaker Brett Cooper, Research Fellow, MSD Development Laboratories spoke to Andrea Charles from Pharma IQ, about the slower than anticipated industry uptake of PAT and QbD. In the podcast, Cooper covers the key
benefits of PAT and QbD implementation and the biggest challenges Pharma and bio companies face regarding the interpretation of regulatory guidance as well as discussing how to prove the business case for PAT and QbD implementation. Brett Cooper’s conference session is
about PAT and QbD within the early develop - ment space. He adds: “At the conference, I will be talking about PAT and QbD within the early development space. This is becoming an increasingly important area of interest within MSD. Establishing the correct QbD strategies and tools early in the development process is key to ensuring we have robust quality products downstream.”
Further information:
The full program, event details, podcasts and registration information are available on
http://www.patandqbd.com/news or email
enquire@iqpc.co.uk
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