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SMi are pleased to announce the arrival of their 4th Annual Pharmaceutical Testing Stability Conference, keeping you abreast of the latest developments affecting the industry. You will hear presentations by recognised industry experts on trends in stability testing, study design, protocol development and how to implement a new stability system. Further consideration will be given to regulatory requirements needed to ensure that all products comply with ICH and FDA guidelines

Listen as influential figures across the industry discuss how to execute efficient and compliant stability testing programmes in a lively and interactive forum.

Discover how this dynamic area is changing and learn about the potential business and technical opportunities that are arising.

Speakers at this year's conference include:

  • Jon Beaman, Senior Director, Pfizer
  • Matthew Bonam, Team Manager, Analytical Development, AstraZeneca R&D
  • Lawrence Rhodes, MS Stability Manager, Global Pharmaceutical Operations, Abbott
  • Dr Stefan Adam, Team Leader, Analytical Sciences, Research & Development, Lilly Research Laboratories
  • Dr Patrick Garidel, Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
  • Dr Paul Newton, Principal Investigator, GlaxoSmithKline
  • Jim Gorski, Associate Director, Stability Operations, Scientific Affairs, Baxter Healthcare
  • Dr Prabu Nambiar, Senior Director, CMC Regulatory Affairs, Cubist Pharmaceuticals

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Ruth Cohen

Ruth Cohen, Associate Director, Quality (Stability), Amgen

Prabu Nambiar

Prabu Nambiar, Senior Director, CMC Regulatory Affairs, Cubist Pharmaceuticals

9:10 DESIGNING GLOBALLY ACCEPTABLE REGISTRATION STABILITY STUDIES

Jon Beaman

Jon Beaman, Senior Director, Pfizer

  • Global regulatory expectations
  • Increased challenges to products/pitfalls
  • Mitigating risks vs cost savings
  • Stability study design options
  • 9:50 REGULATORY REQUIREMENTS: ICH AND FDA GUIDELINES

    Prabu Nambiar

    Prabu Nambiar, Senior Director, CMC Regulatory Affairs, Cubist Pharmaceuticals

  • Overview of drug development process and purpose of stability in each development phase
  • review of cGMP stability testing requirements
  • FDA draft stability guidance’s FDA 483 citations on stability deficiencies- common pitfalls
  • Regulatory acceptability and expectations
  • Statistical analysis
  • Best industry practice
  • 10:30 Morning Coffee

    11:00 STABILITY CHALLENGES IN THE PHARMACEUTICAL INDUSTRY

    Jim Gorski

    Jim Gorski, Associate Director, Stability Operations, Scientific Affairs, Baxter Pharmaceutical Solutions, LLC

  • How to avoid stability pitfalls
  • Test results
  • Identifying and managing out of specification (OOS)
  • Failure investigation - OOS and OOT
  • Investigating stability OOS results
  • Monitoring stability in the channels of distribution
  • 11:40 EARLY PHASE STABILITY TESTING & SCREENING

    Elisabeth  Krug

    Elisabeth Krug, Principal Research Scientist, Eli Lilly

    12:20 Networking Lunch

    13:50 PROTOCOL DEVELOPMENT

    Lesley Bugg

    Lesley Bugg, Team Manager, Pharmaceutical, Analytical Research & Development, AstraZeneca

  • Developing protocols that meet ICH requirements
  • What methods of analysis to adopt?
  • The sampling process
  • Assessing the stability of the drug and the product
  • Testing plan, parameters and results
  • Post-approval commitments
  • 14:30 DEVELOPMENT OF STABILITY INDICATING METHODS

    Stefan Adam

    Stefan Adam, Team Leader, Analytical Sciences, Research & Development, Eli Lilly

  • What stability indicating testing means?
  • What methods need to be stability indicating
  • How to develop stability indicating method development?
  • How to prove the stability indicating ability of the method?
  • 15:10 Afternoon Tea

    15:40 USER REQUIREMENTS OF A COMPREHENSIVE STABILITY STUDY MANAGEMENT SOFTWARE SYSTEM

    Peter Rippington

    Peter Rippington, Senior Consultant, Novatek Europe

  • Current practices for managing stability data
  • Requirements of a comprehensive stability study management software system:
  • - Workflow

    - Study management – schedules - reporting

    - Achieve regulatory compliance

    - Production of statistical data

  • Implementation & validation (GAMP)
  • 16:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:10 PROTEIN – PROTEIN INTERACTIONS AND THE FORMATION OF AGGREGATES IN BIOPHARMACEUTICALS

    Patrick  Garidel

    Patrick Garidel, Process Sciences Department, Formulation Development, Boehringer-Ingelheim

  • Protein aggregation and human etiology
  • Protein-protein interactions and aggregate formation
  • Reasons to aggregate formation
  • Consequences that arise from aggregates
  • Methods for monitoring protein aggregates
  • Inhibition of protein aggregates
  • How to avoid aggregates from forming
  • 9:50 THE CHEMICAL AND PHYSICAL STABILITY OF A CRYSTALLINE DRUG SUBSTANCE

    Chris Frampton

    Chris Frampton, Chief Scientific Officer, Pharmorphix Ltd

    Craig Grant

    Craig Grant, Project Director, Pharmorphix Ltd

    10:30 Morning Coffee

    10:50 INTEGRITY TESTING OF BLISTER DRUG PACKAGING

    Phil Seeney

    Phil Seeney, Management Consultant, Drug Delivery Group, PA Consulting

  • An approach to integrity testing and assessment of packaging
  • Potential moisture correlation approaches
  • The benefits of integrity testing
  • The potential for avoiding unnecessary stability failures
  • 11:30 VALIDATION AND IMPLEMENTATION OF EXISTING TEST METHODS FOR MATURE DRUG SUBSTANCES AND DRUG PRODUCTS

    Paul Newton

    Paul Newton, Principal Investigator, GlaxoSmithKline

  • Effective evaluation scheme for existing methods
  • Enhancing/Redeveloping strategy for current methods
  • Topping off existing or preparing complete validation packages for current or enhanced methods
  • Challenges associated with global implementation of enhanced methods at multiple testing sites
  • 12:10 Networking Lunch

    13:50 CASE STUDY - DEVELOPMENT OF PHASE-DEPENDENT STABILITY TESTING AND METHOD VALIDATION

    Michael  Komenda

    Michael Komenda, Senior Scientist, Team Leader Pharmaceutical Development Group, Schwarz Biosciences

  • Stability testing of early stage products and pre-formulation
  • Orientating stability tests
  • Forced degradation studies
  • Stability tests according to ICH guidelines
  • Method validation in different phases of drug development
  • 14:30 LABORATORY AUTOMATION AS IT APPLIES TO STABILITY ANALYSIS

    Dale VonBehren

    Dale VonBehren, Pharmaceutical Development and Quality Segment Manager , Caliper Life Sciences

  • Overview of different types of stability testing
  • Overview of standardized automated methodologies
  • Attributes that can benefit the quality and efficiency of the stability program
  • Impact on the Development process and Quality Assurance laboratory

  • 15:10 Afternoon Tea

    15:40 BEST PRACTICES IN HPLC METHOD DEVELOPMENT AND VALIDATION

    Fredeon Valianpour

    Fredeon Valianpour, Section Leader Chromatographic Technology, Organon N.V

  • Modern method development strategies and trends
  • Best practices in column/detector selection and sample preparation/extraction
  • Method fine-tuning and optimisation to meet ICH reporting requirements
  • Strategies for HPLC
  • Establish an efficient approach for method transfer
  • Establish an efficient approach for measuring impurities
  • 16:20 RECORD MANAGEMENT

    Charlie Sodano

    Charlie Sodano, Manager, Information Sciences, Berlex Biosciences

  • Record management fundamentals
  • Compliance to FDA requirements
  • Electronic laboratory notebooks
  • Planning for records archiving
  • Record preservation strategies
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

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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, 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.

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    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

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