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Pharmaceutical Stability Testing
15 September - 16 September 2004
Pharmaceutical Stability Testing
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, GlaxoSAE Media GroupthKline, 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 agenda

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Dr Li Shi

    Dr Li Shi, Senior Research Fellow, Merck

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    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
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    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
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    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
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    11:00

    Morning Coffee

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    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
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    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
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    12:50

    Networking Lunch

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    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
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    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
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    15:30

    Afternoon Tea

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    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
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    17:20

    Chairman's Closing Remarks and Close of Conference

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    8:30

    Re-registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Dr Volker Eck

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

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    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
  • clock

    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?
  • clock

    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
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    11:00

    Morning Coffee

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    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
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    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
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    12:50

    Networking Lunch

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    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
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    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
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    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
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    16:10

    Chairman's Closing Remarks and Close of Conference

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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