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[PVS] Stability Testing Conference 2008



Title: Annual Mobile Search

Optimising Stability Testing
Achieving long-term cost-effective stability testing 


17th – 19th September 2008, BSG House, London, UK

 

 Key Speakers
- Jon Beaman, Senior Director, Analytical R&D, Worldwide Pharmaceutical Science, Pfizer
- Usfeya Muazzam, Director and Professor, Federal Institute of Public Health and the Environment
- Susan Smith, Team Manager, Analytical Development, AstraZeneca
- Hui Zhao, Lab Head, Biotechnological Development, Analytical R&D, Novartis
- Patrick Garidel, Process Science Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
- Graham Clarke, Associate Director, Head of Stability Group, Bristol-Myers Squib
- John Smith, Stability Study Team Leader, Analytical Development, Lonza Biologicals
Robert Magari, Senior Staff Biostatistican, Beckman Coulter
- Victoria Jones, Senior Scientist, RSSL
- Anthony Fell, Professor of Pharmaceutical Chemistry, Bradford University
- Stefan Adams, Director, AD&QD LifeCycle Pharma
- Kevan Lucy, Sr Consultant Professional Services, Applied Biosystems

ASSOCIATE SPONSORS: Autoscribe Limited, TeslaTest Systems, H&A Scientific Inc., Applied Biosystems

Identifying strategies to minimise the effects of variable temperature, humidity, and lighting conditions on the structural integrity and biological activity of bio products during development, manufacturing, storage, and administration, is crucial to your stability testing regime. But how can you continue to do this in a cost effective manner? Is outsourcing of the stability testing programme the best-practice for your company? Covering a range of complex issues including, manufacturing, holding time, shipping, freeze/thaw cycles, exposure to oxygen, physical stress and excipient and container compatibility, Visiongain's Stability Testing conference will explore and discuss the current issues, principles and practices relating to the stability of pharmaceuticals and biopharmaceuticals.

With stability testing being a costly and highly regulated part of product development, the need for optimisation is great.

7 benefits you will receive by attending this event?
1. Understand the implications of a focused stability testing programme in your drug development
2. Improve your depth of knowledge and updates of US and EU requirements and ICH-International Conference of Harmonisation
3. Hear the latest FDA requirements for stability testing and compliance issues
4. Clarify when a stability testing programme should be instigated - lessons from the major players
5. Review of package and system in stability testing
6. Understand how to review stability testing results and deliver them throughout your organisation
7. Network and discuss ideas with the leaders in the field

You want to find a long-term cost-effective way of conducting your stability testing, ensuring that you obey with current regulations, and at the same time use your stability data to save money during packaging, transport and storage. To provide an arena for the interchange of experiences and ideas, Visiongain is devoting its second stability testing conference to the optimisation of stability testing. During two days, you will be discussing the optimisation of study design, statistical and analytical methods, data and report management systems and the outsourcing of stability testing with some of the industry best.

 Reasons to attend:
• Find ways to make your stability testing more cost-effective
• Examine different types of study design
• Learn how to avoid common pitfalls in the stability dossier
• Analyse different aspects of pharmaceutical stress testing
• Debate different ways on how to handle the statistical data
• Explore data management systems and their role in sharing stability data locally and globally
• Learn how to optimise your stability testing through outsourcing
• Discuss how often stability studies need to be repeated
• Listen to examples of outsourcings in different phases of the stability study
• Network and discuss ideas with the leaders in the field

Who will be there:
VPs Directors, Heads, and Managers in:
• Stability
• Manufacturing and production
• Validation
• QA/GC
• Analytical methods
• GLO/GMP compliance
• Analytical development
• Validation and troubleshooting
• Product Development
• Technical operations
• Regulatory Affairs
• Packaging, transport and storage
• Documentation and technical writing
• Clinical research organisations


- PRICING -

Workshop + 2 day Conference ticket - available for only GBP £1699   

2 day Conference ticket - available for
GBP £1299 


- BOOKING-

Registration is simple! To book a place please
email jd@xxxxxxxxxxxxxx or call +44(0)2075499946

Please feel free to contact me should you have any questions, or wish to purchase a copy, I look forward to hearing from you.
Kind Regards,

Justyna Drozdzal
Visiongain - Ltd.


Pre-Conference Interactive Workshop

Wednesday 17th September 2008 - Outsourcing of Stability Testing
Led by Robert Haslam, Managing Director, Somerset House Consultants

The workshop will cover:
• Conditions for effective outsourcing
• Which trials are suitable for outsourcing
• How to select a contractor
• Effective communication between the contract giver and contract acceptor
• Who manages the contract
• Problem solving


Conference Agenda

Day One –
Thursday 18th September 2008


09:30 Registration and refreshments

10:00 Opening address from the chair
Graham Clarke, Associate Director, Head of Stability Group, Bristol-Myers Squib

10:10 Stability testing – should we?
• Exploring the decisions as to whether stability studies are needed to be repeated so often during development
• The parameters one should consider to help with decisions
• The hurdles to following scientifically appropriate approaches with some thoughts as to what these could be
Jon Beaman, Senior Director, Analytical R&D, Worldwide Pharmaceutical Sciences, Pfizer


10:50 Characteristics and issues for stability testing
• Examining protein properties and degradation mechanisms
• Discussing analytical methods for protein stability testing
• Optimising the study design for protein stability studies
John Smith, Stability Study Team Leader, Analytical Development, Lonza Biologicals

11:30 Morning refreshments

11:50 Automation and efficiency
• Automation of sample preparation for assay and impurities
• Optimised dissolution testing
• Maximising efficiency of data collection and review (ELN)
Graham Clarke, Associate Research Director, Analytical R&D, Bristol-Myers Squibb

12:30 Degradation studies on monoclonal antibodies
• Degradation pathways of antibodies were investigated under both non-formulated and formulated conditions
• A particular degradation products (e.g., deamindation, oxidation, aggregation, fragmentation) can be enriched by forced degradation studies and used for method validation
• Stability studies (real time and accelerated) can be used to examine inherent stability and determine product shelf life
Hui Zhao, Lab Head, Biotechnological Development, Analytical R&D, Novartis

 14:30 Protein stability screening during the early development phase
• Stability challenges with proteins
• Methods for stability screenings: Pros and Cons
• Challenges with protein aggregation
Patrick GaridelProcess Science Department, Head of Pharmaceutical Basic Development Boehringer-Ingelheim

15:10 Statistical aspect of stability modelling and testing
• Examining the benefits of a matrixed approach
• How to design a multiple storage presentations
• When statistical methods significantly gives a reduction in analytical testing
• It is necessary to select stability indicating methods as early as possible during the development
Robert MagariSenior Staff BiostatisticianBeckman Coulter

15:50 Afternoon refreshments

16:10 Good-bye to Excel and statistical export procedures: Analysis and visualization using advanced stability analytics. Good-by to Excel and statistical export procedures for stability studies
• New integrated analytics regression analysis including ANCOVA analysis for pooling multiple studies
• Complete stability protocol management, data collection, and inventory tracking
• Detailed demonstrations and case studies
Kevan Lucy, Sr Consultant Professional Services Applied Biosystems

16:50 Panel Discussion – Optimising stability testing
• Key issues when optimising stability testing
• Streamlining the stability testing
• Ensuring that the stability testing results are fully used when considering packaging and transport

17:40 Closing remarks from the chair

17:45 Networking Drinks Reception

Take your discussions further and build new relationships in a relaxed and informal setting.

 

Day Two – Friday 19th September 2008

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Avoiding common pitfalls in the stability dossier
• An assessors perspective on the stability dossier
• Compliance with guidelines
• Optimising the submission: Saving time and money
Usfeya Muazzam, Director and Professor, Federal Institute for Drugs and Medical Devices

10:50 Stability testing and primary packaging
• The importance of ensuring a perfect mach
• Sources of contamination
• Practical examples of stability testing and primary packaging
Victoria Jones, Senior Scientist, RSSL

11:30 Morning refreshments

11:50 Optimising the stability testing of therapeutical proteins
• Looking on different uses of the stability testing
• The importance of thermal protein testing
• Considering freeze drying
Werner Kliche, Associated Director, Quality Control, Boehringer-Ingelheim

12:30 Outsourcing of late phase stability studies
• Benefits of outsourcing
• Risks and challenges to consider
• Complex vs. simple dosage forms
Susan Smith, Team Manager, Analytical Development, AstraZeneca

13:10 Networking lunch

14:30 Selection and validation of analytical methods
• Key issues in the selection of appropriate stability-indicating analytical methods
• Strategic approaches to validation of stability-indicating analytical methods
• Innovation in analytical technology for stability programmes
Anthony Fell, Professor of Pharmaceutical Chemistry, Bradford University

15:10 Stability strategies with respect to ICH Q9: How to reasonably combine cost and time efficient stability set-ups with risk management
• General quality risk management process
• Integration of quality risk management into industry and regulatory operations
• Case studies
Stefan Adam, Director, AD&QD, LifeCycle Pharma

15:50 Afternoon refreshments

16:10 Development of analytical methods and settings of rational specifications for biotechnological products
• Examining the definition of drug product specification and how to set these
• Assay development for biotechnological products
• Discussing the impact of making process changes on the specification and comparability
Sven Oliver Arndt, Principal Research Scientist, Merck

16:50 Panel Discussion – Outsourcing stability testing
• What to think about when outsourcing stability testing in different phases
• Outsourcing and communication
• Outsourcing: Benefits vs. Risk

17:30 Chair’s closing remarks

17:40 End of conference

 


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