Informa Annual stability Testing Conference: London 25-26 March

Please see the website for further details www.informa-ls.com/stabilitytesting

Successfully Handling Temperature Excursions and Using Stability Data to Support Product Shelf-Life During Transport and Shipping: Pre-Conference Workshop Tuesday 24 March 2015

This interactive workshop session will provide essential practical advice on managing temperature excursions and using stability data to support product shelf-life during shipping and transport.

Topics to be discussed include:

• Understanding regulatory guidance and requirements available for transport and shipping studies including new European GDP guidance and how to practically apply this
• Recommendations for how and when temperature excursion and temperature cycling studies should be performed
• Calculation of the remaining shelf-life after temperature excursions during shipment
• Biopharmaceutical focus: Managing and understanding the effect of temperature excursions on products requiring cold chain storage

Led by: Claude Ammann, director, Claude Ammann Consulting, Switzerland
Manuel Zahn, managing director, 3R Pharma Consulting GmbH, Germany
Chinedu Madichie, global analytical strategy expert, UCB Pharma, Belguim
Anthony Mazzeo, senior Principal scientist, Bristol-Myers Squibb, USA

Evening Seminar – Ensuring Effective Change Management and Impact on Stability Programs: Wednesday 25 March 2015

Topics to be discussed will include:

• Reviewing regulatory guidance available for stability programs and change management
• Outlining when and which additional stability studies are needed to support CMC changes (e.g. manufacturing site, process or packaging changes) during the lifecycle of a product
• Understanding expectations and requirements from the regulatory authorities for what must be reported when making a change

Led by Manuel Zahn, managing director, 3R Pharma Consulting GmbH, Germany.