3rd Annual Conference 2017
3rd – 5th October 2017
Crowne Plaza Hotel – Blanchardstown, Dublin, Ireland


Conference times:

  • Tuesday 3rd October: 18:15 – 21:00 (ASAP Workshop)
  • Wednesday 4th October: 9:00 – 17:10
  • Thursday 5th October: 9:00 – 17:00

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Program at a glance:

Download Tuesday’s Program Download Wednesday’s Program Download Thursday’s Program


18:1518:30Welcome & Opening Remarks
Accelerated Stability Assessment Program Workshop
Chair: Dr. Ken Waterman
18:3019:15Introduction to the Accelerated Stability Assessment Program - Abstract >
Dr. Sabine Thielges, Novartis, Switzerland. Bio >
19:1519:35Accelerated Stability Assessment Program – Case Study for a tablet drug product - Abstract >
Helen Williams, AstraZeneca, UK. Bio >
19:3519:55Risk-based predictive stability study to support the formulation switch from powder for reconstitution to suspension - Abstract >
Ellen Verheyen, Janssen Pharmaceuticals, Belgium Bio >
19:5520:15Case Study: Applying Accelerated Stability Assessment Program to Excursions, Formulation and Process Changes - Abstract >
Dr. Garry Scrivens, Senior Principal Chemist Pfizer, UK Bio >
20:1520:35Accelerated Stability Assessment Program – Case Study for a Gelatin Capsule Drug Product - Abstract >
Peter O’Connell, Cuspor, Ireland. Bio >
20:3521:00Panel Discussion: Use and Implementation of Accelerated Stability Assessment Program
Panelists: Dr. Garry Scrivens, Dr. Sabine Thielges, Helen Williams, Ellen Verheyen & Peter O’Connell


Session 1: Physical Stability Considerations
Chair: Dr. John M. Campbell
09:0009:40Physical Form Changes (Polymorphism and Disproportionation) and their Influence on Impurity Formation - Abstract >
Dr. Gregory Stephenson, CrystalPharmatech, USA. Bio >
9:4010:20Understanding and managing the risk of physical instability in a challenging drug product design space - Abstract >
Dr. Paul Whiteside, Pfizer, UK Bio >
10:2010:50Morning Break
Session 2: Oxygen Related Topics
Chair: Dr. John M. Campbell
10:5011:30Overview of Pharmaceutical Oxidative Degradation Mechanisms - Abstract >
Dr. Steven W. Baertschi, Baertschi Consulting, USA. Bio >
11:3012:10Oxygen sensitivity modelling and packaging implications - Abstract >
Dr. Ken Waterman, FreeThink Technologies Inc., USA Bio >
12:1012:50New type of oxygen scavenger for pharmaceutical packaging - Abstract >
Prof. Zenon Foltynowicz, Poznan University, Poland. Bio >
Session 3: Early Stage Stability Strategies - I
Chair: Dr. Gregory Stephenson
14:0014:40Degradation Mechanism Elucidation: A Case Study in Leveraging Scientific Understanding to Design a Stable Drug Product - Abstract >
John M. Campbell, Ph.D. GlaxoSmithKline, USA Bio >
14:4015:20Drug – Excipient Interactions: The Effect of Drug Load and Humidity on Degradation Rate - Abstract >
Dr Garry Scrivens, Pfizer, UK. Bio >
15:2015:50Afternoon Break
Session 4 - Early Stage Stability Strategies - II
Chair: Dr. Gregory Stephenson
15:5016:30Designing Stable Formulations - Abstract >
Thomas Andersson, AstraZeneca, Sweden. Bio >
16:3017:10Applications of Predictive Stability in Early Development - Abstract >
Helen Williams, AstraZeneca, UK. Bio >


Session 5: Predicting Stability for Solutions & Stable Products
Chair: Helen Williams
08:4509:25Prediction of Solution Phase Stability - Abstract >
Dr. Garry Scrivens, Pfizer, UK. Bio >
09:2510:05Justifying shelf-lives when no degradation observed at accelerated conditions - Abstract >
Dr. Kenneth C. Waterman, FreeThink Technologies Inc., USA. Bio >
10:0510:35Morning Break
Session 6: Miscellaneous
Chair: Helen Williams
10:3511:15Electrochemical degradation approach for forced degradation studies - Abstract >
Jean-Pierre Chervet, Antec Scientific, Netherlands. Bio >
11:1511:55Newest Regulatory Experiences - IQ risk-based predictive stability update - Abstract >
Dr. Elke Debie, Janssen Pharmaceuticals, Belgium. Bio >
Ellen Verheyen, Janssen Pharmaceuticals, Belgium. Bio >
11:5512:35Drug–excipient interactions in the solid state: The role of different stress factors - Abstract >
Amrit Paudel, Research Center Pharmaceutical Engineering (RCPE), Austria Bio >
Session 7: Predicting Stability - Understanding statistics and humidity
Chair: Dr. Steve Baertschi
13:4014:20Stability Prediction Modelling - Statistics Considerations - Abstract >
Jonathan Bright, Statistician, AstraZeneca, UK Bio >
14:2015:00Humidity Measurement in Stability Testing Applications - Defining Uncertainty and the Challenges at high temperatures - Abstract >
Robin Farley, MBW Calibration, Switzerland. Bio >
15:0015:30Afternoon Break
Session 8: Stabilising amorphous formulations and deformation of mesoporous materials
Chair: Dr. Steve Baertschi
15:3016:10Stabilising amorphous formulations: Characterising the mechanisms that control the stability of disordered
pharmaceutical materials - Abstract >
Dr Paul G. Royall, King’s College London, UK. Bio >
16:1016:50Water vapor adsorption induced deformation of mesoporous materials - Abstract >
Dr. Juergen Adolphs, Porotec, Germany. Bio >
16:5017:00Closing Remarks