Home
overview
SMi’s Pharmaceutical Stability Conference will provide vital information on how to evaluate, characterise and solve chemical instability issues during the production of Pharmaceuticals. Stability and related issues have been the cause of numerous drug product recalls in recent years and represents a very real problem for the industry.

The Conference is designed to appeal to those involved in all stages of stability testing, providing a forum in which leading experts can discuss and evaluate the current issues in pharmaceutical stabilisation and offer ideas on current and future solutions. The event will look into the regulatory requirements and their impact on stability testing, evaluate available technologies, examine the industrial practicalities of developing stability information and discuss methods and techniques for test protocols and for analysing stability test results.

A unique opportunity to learn from leading industry experts including:
Dr Dhiren Shah, Director, Regulatory Chemistry, Manufacturing & Controls (CMC), Aventis
Dr Andy Rignall, Team Manager, Analytical Development, AstraZeneca
Dr Dharmendra Singhal, Senior Research Investigator, Solids Research Group, Pfizer
Dr Andrea Panaggio, Associate Director, Exploratory Biopharmaceutics & Stability, Bristol-Myers Squibb
Dr Li Shi, Senior Research Fellow, Merck
Dr Jef Peeters, Research Fellow, Pharmaceutical Sciences, Johnson & Johnson
Dr Vibeke Bjerregaard, Regulatory Affairs Manager, Novo Nordisk
Brian Clark, Manager, Analytical Development, AstraZeneca
Dr Karen Malik, Senior Director, Scientific Affairs, Baxter Healthcare
Timothy Schofield, Director, Vaccine Biometrics Research, Merck

Benefits of attending:
STABILITY SCREENING: Learn about testing new drug substances in early development
OOS/OOT: Discover effective ways through OOS/OOT investigations
FDA REQUIREMENTS: Hear about FDA requirements for stability testing and compliance issues
COMPUTERISED STABILITY SYSTEMS: Gain an insight into the technologies and systems available
HARMONISATION OF STABILITY TESTING: Find out about the compliance to international requirements
MANAGING RISK OF STABILITY STUDIES: Understand the limitations on the interpretation of stability studies
INDUSTRY LEADERS: Network and discuss ideas with the leaders in the field

"Stability testing is an integral and critical part of pharmaceutical product development for successful registration and commercialisation.
This is an important event for bringing together thought leaders from the industry and regulatory agencies so key issues can be discussed in detail"
Dr Maninder Hora, Vice President, Process & Product Development, Chiron

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Maninder Hora

Dr Maninder Hora, Vice President, Process & Product Development, Chiron

9:10 STABILITY SCREENING OF NCEs

Dr Jef Peeters

Dr Jef Peeters, Research Fellow, Pharmaceutical Sciences, Johnson & Johnson

  • Solutions and suspensions · Aqueous solution · Non-aqueous solution
  • Solid state · Drug substance · Drug product candidates
  • 9:40 PREDICTION AND MONITORING OF PHYSICAL STABILITY

    Dr Andy Rignall

    Dr Andy Rignall, Team Manager, Analytical Development, AstraZeneca

  • Physical stability as a development candidate selection criteria
  • Assessment of physical stability and predictive tools
  • Monitoring physical stability as part of a stability programme
  • Physical stability data assembly for the Chemistry, Manufacturing and Control module
  • 10:20 DEVELOPING GLOBAL STABILITY PROTOCOLS

    Dr Andrea Panaggio

    Dr Andrea Panaggio, Associate Director, Exploratory Biopharmaceutics & Stability, Bristol-Myers Squibb

  • Input needed to design a good registration
  • Design of the protocol
  • Defining the stability profile of the product
  • Clinical and screening stability
  • Constructing tests to ensure suitable protocols
  • 11:00 Morning Coffee

    11:20 VALIDATION OF A STABILITY INDICATING METHOD

    Saji Thomas

    Saji Thomas, Group Leader, Purdue Pharma

  • Developing a stability indicating method
  • Validation of the method
  • Conducting forced degradation
  • Determining the robustness of the method
  • Transferring the method from R&D to QC lab
  • 12:00 PHARMACEUTICAL MOLECULES

    Dr Dharmendra Singhal

    Dr Dharmendra Singhal, Senior Research Investigator, Solids Research Group, Pfizer

  • Chemical stability of drug substance
  • Solution vs solid state
  • Chemical stability in solid dosage forms
  • Effect of excipients
  • Effect of compression
  • Methods for excipient compatibility
  • Stabilisation approaches
  • 12:40 Lunch

    13:40 UNDERSTANDING THE STABILITY OF PHARMACEUTICALS

    Dr Saliesh Varia

    Dr Saliesh Varia, Director, Bristol-Myers Squibb

  • Why is stability and stabilisation important in pharmaceutical dosage forms?
  • Understanding the mechanism of both physical and chemical instability
  • How much degradation can be tolerated in pharmaceutical dosage form?
  • Case studies of instability in pharmaceuticals and approaches for stabilisation
  • 14:20 Stability Software: Developing advanced solutions for 21 CFR part 11

    Dr Saliesh Varia

    Dr Saliesh Varia, Director, Bristol-Myers Squibb

  • Requirements of an 21 CFR part 11 compliant software application
  • Validation
  • Security and access privileges
  • Training
  • SOP and document tracking
  • Electronic Signatures
  • 15:00 SELECTION AND IMPLEMENTATION OF COMPUTERISED STABILITY SYSTEM

    Dr Karen Malik

    Dr Karen Malik, Senior Director, Scientific Affairs, Baxter Healthcare

  • Functionality of the system
  • Capabilities and limitations
  • Choosing the most appropriate system
  • Development and validation of a stability system
  • Training and procedure requirements
  • System maintenance
  • Cost and benefits of a computerised system
  • 15:40 Afternoon Tea

    16:00 STABILITY OF PROTEINS IN MIXED SYSTEMS

    Dr Maninder Hora

    Dr Maninder Hora, Vice President, Process & Product Development, Chiron

  • Protein stability and degradation mechanisms
  • Protein stability in emulsions
  • Protein stability in microspheres
  • Implications to product development
  • 16:40 FACTORS TO CONSIDER IN FORMULATION MACROMOLECULES

    Dr Kevin King

    Dr Kevin King, Senior Principal Scientist, Pfizer

  • Biopharmaceuticals
  • Main degradation pathways of proteins
  • Formulation tools to improve stability
  • Analytical requirements
  • Factors influencing protein stability
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Saji Thomas

    Saji Thomas, Group Leader, Purdue Pharma

    9:10 CONFORMING TO FDA REQUIREMENTS

    Dr Dhiren Shah

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

  • Regulatory stability testing requirements
  • Strategies for global compliance
  • Issues and guidelines surrounding FDA
  • Label and packaging
  • Submission of data
  • 9:40 HARMONISATION FOR STABILITY PROTOCOLS

    Dr Petra Loos

    Dr Petra Loos, Principal Scientist, Aventis

  • Regulatory requirements in Europe, US and Japan
  • How do regulations differ across regions?
  • How can regulations be harmonised?
  • How to prepare a global stability protocol
  • 10:20 STABILITY DATA SUPPORTING CHANGE OF BIOTECHNOLOGICAL PRODUCTS

    Dr Vibeke Bjerregaard

    Dr Vibeke Bjerregaard, Regulatory Affairs Manager, Novo Nordisk

  • EU requirements in a global context
  • Comparability considerations
  • Issues on harmonisation across regions
  • Strategies for compliance
  • 11:00 Morning Coffee

    11:20 OUT OF SPECIFICATION (OOS) AND OUT OF TREND (OOT)

    Niall Dinwoodie

    Niall Dinwoodie, Head, Product Characterisation, Inveresk

  • Invalid or OOS? Defining appropriate assay acceptance criteria
  • The most effective way through an OOS investigation
  • Use of existing information to investigate OOS/OOT results
  • When to retest stability samples and what is a sufficient number of analyses
  • Understanding OOT investigations as an opportunity in stability studies
  • Procedures for biologically based arrays
  • 12:00 STABILITY TESTING OF BIOPHARMACEUTICALS

    Dr Steve Flatman

    Dr Steve Flatman, Head, Assay Development, Lonza Biologics

  • Properties of protein
  • Degradation mechanisms
  • Analytical methods
  • Study design
  • Relevance to ICH Q5C
  • 12:40 Lunch

    13:40 STABILITY TESTING OF COMPLEX PRODUCTS

    Brian Clark

    Brian Clark, Manager, Analytical Development, AstraZeneca

  • Test protocol
  • Analytical methodology
  • Impact of excipients
  • Impact of terminal sterilisation
  • 14:20 ENHANCING VACCINE STABILITY

    Dr Li Shi

    Dr Li Shi, Senior Research Fellow, Merck

  • Preformulation research
  • Formulation approaches
  • Stability evaluation strategy and implementation
  • 15:00 STABILITY OF CLINICAL TRIAL MATERIALS

    Panagiotis Patsilinacos

    Panagiotis Patsilinacos, Business Development Manager, Quintiles

  • Limitations
    Rules
  • Basic regulatory requirements
    Active substance requirements
  • Finished product requirements
  • Summary of principles
  • Stability information needs
  • Comparators/blinding
  • 15:40 Afternoon Tea

    16:00 UNDERSTANDING AND MANAGING THE RISK OF STABILITY STUDIES

    Timothy Schofield

    Timothy Schofield, Director, Vaccine Biometrics Research, Merck

  • Setting shelf life vs monitoring product stability
  • Statistical properties of stability data and risk of OOS results
  • Managing risk of OOS results
  • Protecting the customer using release potency
  • Protecting the producer using manufacturing models
  • 16:40 ICH STABILITY GUIDELINES

    Clive Seaton

    Clive Seaton, Senior Technical Consultant, InnaPhase

  • What is ICH? The history of the ICH organisation
  • Current guidelines for ICH compliant stability studies
  • The reasons for performing stability testing and the types of tests and data that must be recorded
  • Management of stability studies
  • Software solutions
  • 17:20 Chairman's Closing Remarks Followed by Afternoon Tea.
    Close of Conference

    +

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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, SMI 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@smi-online.co.uk

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.