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The 2004 Pharma Stability Testing Conference is this year's "must attend" event.

Meet the Regulators - we are lucky enough to have the UK's Medicines & Healthcare Products Regulatory Agency, and two ex-FDA officials on hand to really give you the insiders view on getting your stability testing right.

Big Pharma Experience - this year you have a unique opportunity to learn from the leading stability testing experts in each of the following big pharma companies:

  • Pfizer
  • Aventis
  • Abbott Labs
  • Merck
  • Sanofi-Synthelabo
  • AstraZeneca
  • Baxter Healthcare


  • What you will learn at this major event: how to -

    1) Establish a practical stability programme from ground zero
    2) Comply with the latest ICH and SPMP stability guidelines
    3) Meet new FDA requirements
    4) Address the key stability issues at each stage in the drug development process
    5) Develop best practice analytical methods
    6) Prevent and overcome common stability problems
    7) Assess the financial effects of stability problems


    Who will you meet at this event - Previous attendees include:

    3M Healthcare, Abbott, Allergan, Amersham Biosciences, Amgen, AstraZeneca, Aventis, Bayer, Biogen I'dec, Boehringer Ingelheim, Bristol-Myers Squibb, Celltech, Covance, Elan Pharma, Eli Lilly, F Hoffmann-La Roche, GlaxoSmithKline, Lundbeck, Janssen, Johnson & Johnson, Karo Bio, KMI/Parexel, Knoll Pharmaceuticals, Merck & Co, Merck KGaA, Merck Sharp & Dohme, Millennium Pharmaceuticals, Novartis, Novo Nordisk, Ortho Biotech, Pfizer, Pharmacia & Upjohn, Pliva, Procter & Gamble, Quintiles, Roche, Sanofi Synthelabo, Schering AG, Serona, Wyeth and many more.

    Practical tools and techniques:

    You will learn how to set up programmes, compile checklists, develop systems, set up training programmes, validate methods and much more...

    Plus...

  • Why the best stabilisation offence is defence
  • Briefing on the latest regulation from the MHRA
  • Update from two ex-FDA officials
  • Real world examples and casestudies from industry insiders
  • Best practice casestudies on desiging your stability tests
  • Lessons from Merck and Intercell on stability testing in vaccine development

    Learn from the international experts:

    Pfizer are presenting two key sessions on:
  • how to assess the impact of formulation variables on chemical stability
  • how to evaluate data in accordance with Q1E

    Plus, Abbott Laboratories are presenting two key sessions on:
  • how to design and evaluate tests for early R&D stability
  • how intermediate processing can impact purity and stability

    Plus, case studies from Quintiles, Baxter, Aventis, Intercell, Lonza, Abbott, Merck, Pfizer, Sanofi, AstraZeneca, Pharmalytica and Millennium
  • Conference programme

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Li Shi

    Dr Li Shi, Senior Research Fellow, Merck

    9:10 A REGULATORY UPDATE

    Sue Harris

    Sue Harris, Unit Manager, Licensing Division, Medicines & Healthcare Products Regulatory Agency (MHRA)

  • Relevant stability guidelines
  • Data requirements
  • Common deficiencies
  • Implications for storage conditions
  • Some examples
  • 9:40 COMPLYING WITH THE FDA AND ICH REQUIREMENTS FOR STABILITY TESTING

    Dr Dhiren Shah

    Dr Dhiren Shah, Director, Regulatory Chemistry, Manufacturing & Controls (CMC), Aventis

  • Review and implement the ICH guidelines
  • Review and discuss FDA requirements and expectations
  • 10:20 EARLY R&D STABILITY EVALUATION AND EXPERIMENTAL DESIGN

    Dr William Porter

    Dr William Porter, Associate Research Fellow, Abbott Laboratories

  • Thermal stress experiments
  • Photochemical stress experiments
  • Precision calorimetry experiments for identifying potential stability problems with new chemical entities and their interactions with excipients
  • 11:00 Morning Coffee

    11:30 ADDRESSING PHARMACEUTICAL STABILITY AT DIFFERENT STAGES OF VACCINE DEVELOPMENT

    Dr Li Shi

    Dr Li Shi, Senior Research Fellow, Merck

  • Vaccine formulation development cycles
  • Strategies of addressing stability at different development stages
  • Stability during basic research and preclinical development
  • Stability at early and later phases of clinical studies
  • Stability during technology transfer and process validation
  • Case studies
  • 12:10 ANALYTICAL METHOD DEVELOPMENT FOR STABILITY TESTING DURING VACCINE DEVELOPMENT

    Dr Constantia Kast

    Dr Constantia Kast, Scientist, Pharmaceutical Development, Intercell

  • Development of stability indicating methods
  • Characterisation of degradation products
  • Capabilities and limitations of HPLC analysis
  • Stability studies during vaccine development
  • Possibilities to improve stability during development
  • 12:50 Networking Lunch

    14:10 HOW TO PREVENT AND REACT TO STABILITY PROBLEMS

    Dr Raymond Skwierczynski

    Dr Raymond Skwierczynski, Director, Formulation Science, Millennium

  • Financial effect of a stability problem
  • Value added stability strategies and tasks for each development stage gate
  • Why the best stabilisation offence is defence
  • 14:50 IMPACT OF FORMULATION VARIABLES ON CHEMICAL STABILITY OF SOLID DOSAGE FORMULATIONS

    Dr Scott Smith

    Dr Scott Smith, Director, Exploratory Pharmaceutics, Pfizer

  • Chemistry and physics of drug-excipient interactions
  • Salt-form effects
  • Mechanical processing effects on reactivity
  • 15:30 Afternoon Tea

    16:00 SPECIFIC CHARACTERISTICS AND ISSUES FOR STABILITY TESTING

    Alison Sykes

    Alison Sykes, Manger, Product Stability & Formulation, Lonza Biologics

  • Properties of protein
  • Degradation mechanisms
  • Analytical methods
  • Study design
  • Relevance to ICH Q5H
  • 17:20 Chairman's Closing Remarks and Close of Conference

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Volker Eck

    Dr Volker Eck, Director, Analytical Research & Development, Pharmacia Italia, Pfizer Group

    9:10 STABILITY TESTING AT VARIOUS R&D PHASES

    Tony West

    Tony West, Director, Analytical Sciences, Sanofi-Synthelabo

  • Why is phased stability testing important?
  • Stability testing as part of the salt selection process
  • Stability testing through preclinical and early phase development
  • A structured approach to shelf life prediction
  • Stability metrics
  • The importance of adequate stability documentation
  • 9:40 STABILITY TESTING

    Dr Volker Eck

    Dr Volker Eck, Director, Analytical Research & Development, Pharmacia Italia, Pfizer Group

  • How to design studies to obtain meaningful data
  • What data is needed?
  • How to treat the data correctly
  • What to do if data is not homogeneous
  • What if there is only little data available?
  • 10:20 STABILITY TESTING OF COMPLEX DOSAGE FORMS

    Dr Andy Rignall

    Dr Andy Rignall, Team Manager, Analytical Development, AstraZeneca

  • A survey of relevant guidance on this specific dosage form
  • The critical chemical and physical stability tests associated with pressurised metered dose inhalers
  • Appropriate analytical techniques for solving the chemical and physical challenges
  • Extractables and leachables issues
  • 11:00 Morning Coffee

    11:30 STABILITY TESTING PROGRAM FOR FROZEN DRUG PRODUCTS

    Joseph Fosco

    Joseph Fosco, Associate Director, Stability Operations & Product Development, Baxter Healthcare

  • Formulation development
  • Container system selection
  • Protocol development
  • Timing and logistics
  • Data assessment and reporting
  • Commercial product support
  • 12:10 STABILITY TESTING

    Katrine Bonner

    Katrine Bonner, Business Development Manager, Quintiles

  • Guidance for product failure investigation
  • Techniques and instrumentation available for the investigation of product failure
  • Selection of the best instrumental techniques for the rapid identification of causative factors
  • Case studies
  • 12:50 Networking Lunch

    14:10 STABILITY OF COMBINATION PRODUCTS

    Dr Steven Koepke

    Dr Steven Koepke, Director, PharmaNet (Formerly FDA)

  • Recognise and adjust for the differences in the stability of combination products
  • Understand and apply the appropriate regulatory guidances concerning stability testing
  • Prepare for interactions with the FDA
  • 14:50 STABILITY OF BIOTECHNOLOGY PRODUCTS

    Dr Duu-Gong Wu

    Dr Duu-Gong Wu, Director, PharmaNet (Formerly FDA)

  • Due to their complex structures biotech products are extremely sensitive to environmental changes
  • Degradation pathways are unique and can differ considerably from standard drugs
  • Regulatory considerations of storage conditions, degradation products and the analytical methods/assays all require special consideration
  • 15:30 LOOKING BEYOND THE FINAL PRODUCT

    Dr Eric Stoner

    Dr Eric Stoner, Group Leader, Process Chemistry Research & Development, Abbott Laboratories

  • Why look backwards when examining API stability?
  • How can intermediate processing impact API purity and stability?
  • Case studies
  • 16:10 Chairman's Closing Remarks and Close of Conference

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