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Following the success of last year’s event, SMi are proud to announce their 3rd Annual Conference on Pharmaceutical Stability Testing. This event aims to provide vital information on how to evaluate, characterise and solve chemical instability issues during the production of pharmaceuticals and help prevent numerous drug product recalls.

SMi’s Pharmaceutical Stability Testing event will provide a detailed analysis of the current techniques and methodologies associated with the stability testing of pharmaceuticals and biopharmaceuticals. This will include an assessment of current regulations and criteria governing the safe stability of products, challenges and limitations, emerging stability technologies reaching the market and the development of effective stability protocols. This conference will provide a forum in which leading experts can discuss and evaluate the current issues in pharmaceutical stabilisation and generate/offer ideas on potential current and future solutions.

A unique opportunity to learn from leading industry experts including:

  • Paula Youngberg Webb, Senior Director, Stability Operations, Scientific Affairs, Baxter
  • Dr Luk Li, Director, Global Drug Delivery, Abbott Laboratories
  • Dr Dhiren Shah, Director, Corporate Regulatory Affairs, RCMC, Sanofi-Aventis
  • Dr Raymond Skwierczynski, Director, Formulation Science, Millennium Pharmaceuticals
  • Patrick Bell, Manager, Stability, Wyeth Pharmaceuticals
  • Dr James Carroll, Associate Research Fellow, Pfizer
  • Dr Satyam Upadrashta, Senior Director, Regulatory Affairs & CMC Development, ARADIGM
  • Mary Befast, Research Chemist, Merck
  • Dr Constantia Kritsch, Senior Staff Scientist, Intercell

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Luk Chiu Li

Luk Chiu Li, Director, Global Drug Delivery, Abbott Laboratories

9:10 PRINCIPLES AND PRACTICES OF PHARMACEUTICAL

  • Importance of stability testing
  • Principles of stability
  • Regulatory aspects of stability
  • Satyam Upadrashta

    Satyam Upadrashta, Senior Director, Regulatory Affairs & CMC Development, ARADIGM

    Prabu Nambiar

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

    9:50 PREFORMULATION AND STABILISATION OF PHARMACEUTICALS

    Raymond Skwierczynski

    Raymond Skwierczynski, Director, Formulation Science, Millennium Pharmaceuticals

  • What are the main causes of degradation?
  • Current challenges in meeting stability requirements
  • Designing and implementing a cost-effective stability programme
  • How can we enhance drug stability?
  • 10:30 Morning Coffee

    11:00 REGULATORY AND SCIENTIFIC CONSIDERATIONS ON

    Duu-Gong Wu

    Duu-Gong Wu, Executive Director (former Deputy Director, FDA), PharmaNet

  • US regulatory requirements for stability testing of drug substances and products
  • Regulatory and scientific considerations on design of stability protocols
  • Special issues on stability testing of chemical and biological drugs
  • Comparability and stability testing before and after drug approvals
  • 11:40 COMPONENTS OF STABILITY TESTING

    Patrick Bell

    Patrick Bell, Manager, Stability, Wyeth

  • Stability protocols
  • Stability summary reports
  • Annual product evaluation reports
  • How does practical reporting work for your company?
  • 12:20 Networking Lunch

    13:50 THE IMPACT OF WATER ON PHARMACEUTICAL PRODUCT

    Teresa Carvajal

    Teresa Carvajal, Ass. Professor in Industrial & Physical Pharmacy, Purdue University

  • How to maintain the integrity and stability of a product
  • The physical and mechanical aspects
  • Chemical aspects
  • Processing aspects
  • Effect of residual moisture on the physical stability and regulations
  • 14:30 AUTOMATED SOLUTIONS FOR STABILITY TESTING

    Kevin Deane

    Kevin Deane, Managing Consultant, PA Consulting

  • Barriers to applying automation to pharmaceutical stability testing
  • The potential business and technical benefits of automated systems
  • Outsourcing vs in-house testing
  • Lessons learned in developing similar systems
  • What the future may look like
  • 15:10 Afternoon Tea

    15:40 STABILITY MANAGEMENT SOFTWARE SYSTEMS

    Peter Rippington

    Peter Rippington, Senior Consultant, Novatek Europe

  • The 21 CFR Part 11 regulations
  • Regulations and user requirements
  • Designing specifications
  • Validating test scripts
  • 16:20 STABILITY EVALUATION OF DRUG DELIVERY PRODUCTS

    Luk Chiu Li

    Luk Chiu Li, Director, Global Drug Delivery, Abbott Laboratories

  • Stability characteristics of drug delivery products
  • Drug delivery products formulated with lipid carriers
  • Biodegradable polymeric depot systems
  • Transdermal systems
  • Pulmonary delivery systems
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Patrick Bell

    Patrick Bell, Manager, Stability, Wyeth

    9:10 DEALING EFFECTIVELY WITH OOS / OOT RESULTS DURING STABILITY TESTS

    Gerry Maxwell

    Gerry Maxwell, Head, Pharmaceutical Analytics, NDA Analytics

  • Impact of OOS / OOT results during stability studies
  • Effective & efficient investigation procedures
  • Prevention is better than cure
  • Review of relevant FDA warning letters
  • 9:50 ANALYTICAL CHARACTERISATION OF THERAPEUTIC

    James Carroll

    James Carroll, Associate Research Fellow, Pfizer

  • Therapeutic proteins undergo several degradation pathways upon storage
  • Many of these pathways can be predicted utilising forced or accelerated degradation studies
  • A variety of analytical methods are utilised for the characterisation of minor degradation products and impurities
  • Quantitative methods are necessary to monitor and control these degradation products
  • HPLC and mass spectrometry are critical tools for the characterization of these species
  • 10:30 Morning Coffee

    11:00 PANEL DISCUSSION

  • What are the possibilities for efficient testing?
  • Are people currently practising this approach?
  • Satyam Upadrashta

    Satyam Upadrashta, Senior Director, Regulatory Affairs & CMC Development, ARADIGM

    Patrick Bell

    Patrick Bell, Manager, Stability, Wyeth

    Mary Belfast

    Mary Belfast, Research Chemist, Merck

    Duu-Gong Wu

    Duu-Gong Wu, Executive Director (former Deputy Director, FDA), PharmaNet

    11:40 STABILITY TESTING DURING VACCINE DEVELOPMENT

    Constantia Kritsch

    Constantia Kritsch, Senior Staff Scientist, Intercell

  • Stability indicating methods
  • Stability during basic vaccine development / research
  • Strategies of addressing stability during formulation development
  • Practical aspects of stability testing (case study)
  • Validation of stability indicating analytical methods
  • 12:20 Networking Lunch

    14:00 OPTIMISATION AND VALIDATION OF ASSAYS FOR COMPLEX COMBINATION VACCINES

    Mary Belfast

    Mary Belfast, Research Chemist, Merck

  • Strategy to optimise and validate assays for vaccines
  • Practical application of multi-factor experimental design to find hidden interactions
  • Application of stability indicating assays
  • 14:40 STABILITY OF COMBINATION PRODUCTS

    Steven Koepke

    Steven Koepke, President, SRK Consulting

  • Combination products have unique stability concerns and their regulatory status is evolving
  • The current status of these stability requirements will be discussed in this presentation
  • Bracketing and matrixing can be acceptable if appropriately justified
  • Stability requirements are considerably more stringent for combination products
  • Key factors for approval will be discussed
  • 15:20 STABILITY TESTING PROGRAMME FOR READY TO USE PREMIX PARENTERAL PRODUCTS

    Paula Youngberg Webb

    Paula Youngberg Webb, Senior Director, Stability Operations, Scientific Affairs, Baxter Healthcare Corporation

  • Introduction to Ready To Use (RTU) dosage forms
  • Dosage form selection for parenterals
  • Container system selection
  • Stability considerations during development
  • Stability testing considerations
  • Commercial Product Support
  • 16:00 Chairman’s Closing Remarks Followed by Afternoon Tea

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