Pharmaceutical Stability Testing Conference
15th and 16th September 2010, CCT Venues - Smithfield,
London
E.:
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T.: +44(0)20 7368 9300
Display url - www.stabiliitytestingevent.com
Pressure to ensure that the regulatory requirements for
stability testing are fulfilled, first time has never been higher with the
pharmaceutical industry as a whole focusing on cutting margins and avoiding
recalls. This conference will feature a number of case studies where your
fellow peers highlight how they have approached different aspects of Stability
Testing to ensure efficiency and compliance.
Key industry experts will discuss such topics as:
Cutting
stability testing costs through effective outsourcing: Bristol Myers Squibb
discuss how to successfully source and manage 3rd party CRO's in European and
emerging markets
Designing
stability testing strategies to overcome challenges with inhalation drugs:
Skyepharma discuss how to approach and prepare for the challenges ahead
How to ensure
first-time approval and compliance in the largest part of your NDA through key
regulatory updates from the MHRA and RIVM, with discussion of the current
ICH/WHO Guidelines and amendments
Maintain
control of product stability across the transport chain by tracking and
predicting potential trouble spots: TopoTarget discuss how they could prepare
through prediction
Effectively
adopt Quality by Design as part of your stability testing programme: Abbott
share their experiences
Speakers include:
Dr Paul
Marshall, Senior Pharmaceutical Assessor, MHRA UK
Matthijs.J.
van Haren, Chemical-Pharmaceutical Assessor/Researcher, RIVM The
Netherlands
Shekar
Natarajan, Senior Executive CMC Affairs EMEA, Johnson and Johnson
Claude Amman,
Site Manager and QA/QC Director, Topotarget
Dr Manual
Zahn, Managing Director, 3R Consulting Ltd.
Dr Tila
Balasuriya, Group Leader Stability, Bristol Myers Squibb
Dr David
Elder, Director Product Development, GlaxoSmithKline
Mohamed
Oubihi, Senior Manager International Regulatory Affairs, Biogen Idec UK Ltd.
Dr Stefan
Adam, Senior Group Leader GGSA3, Abbott GmbH
Visit www.stabilitytestingevent.com
for more information.While on the site,
you can access a complimentary podcast interview with Shekhar Natarajan, Senior
Executive-CMC Regulatory Affairs, Johnson & Johnson. Shekhar Natarjan
discusses 'Establishing an Effective and Efficient Stability Testing
Programme'. Shekhar will be a speaker at the Conference.
Language:
English
Organization:
IPQC
Contact person:
Pharma IQ
Email:
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