Developing successful stability testing strategies to avoid recalls, manage resources and implement cutting edge practices
The 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.
