Science of Stability

Transcription

1 IT S ALL ABOUT THE SCIENCE Science of Stability 3rd Annual Conference rd - 5 th Ocber Crowne Plaza Hotel - Blanchardswn Dublin, Ireland science of stability 3rd annual conference 2017

2 sponsors science of stability 3rd annual conference 2017

3 INFORMATION HELP DESK Patricia at the registration desk is happy deal with any queries you may have. You can also contact the desk by calling or texting or COURTESY We request that all mobile phones are set silent mode and lapps are not used during presentations. During the conference please ensure you wear your badge and it s visible at all times. QU E S TIONS You are encouraged ask questions at the end of each presentation. Please wait for the microphone reach you and state your name and company before asking question. PR E SENTATIONS Copies of speaker presentations we are permitted share with delegates will be made available via the conference delegates via when presentations are available. WIFI WIFI is complimentary - no login required.

4 security The presentation room will be watched over during coffee breaks and lunchtime. We regret that neither the conference organisers or the venue can be held responsible for any loss or damage your property. cloakroom There is a supervised cloakroom available throughout the event Please do not leave valuables in the cloakroom. The conference organisers or the venue will not be held responsible for any loss or damage your property. conference evaluation It would be greatly appreciated if delegates can complete online evaluation following event. Notification will be sent delegates via when evaluation form available on conference website will only take 3 minutes complete. phographs Conference phographer will be taking phographs throughout the conference. You will not be included in any phograph without your permission. wednesday night If you are interested in joining fellow delegates for dinner in Dublin City on Wednesday night then please inform Patricia at the desk by no later than 1pm on Wednesday. science of stability 3rd annual conference 2017

5 TUESDAY 3 rd Ocber 1 17:45 18:15 18:15 18:30 Registration Welcome & Opening Remarks accelerated stability assessment program workshop Chair: Dr. Ken Waterman 18:30 19:15 19:15 19:35 19:35 19:55 19:55 20:15 20:15 20:35 20:35 21:00 Introduction the Accelerated Stability Assessment Program Dr. Sabine Thielges, Novartis, Switzerland Accelerated Stability Assessment Program Case Study for a tablet drug product Helen Williams, AstraZeneca, UK Risk-based predictive stability study support the formulation switch powder for reconstitution suspension Dr. Ellen Verheyen, Janssen Pharmaceuticals, Belgium Case Study: Applying Accelerated Stability Assessment Program Excursions, Formulation and Process Changes Dr. Garry Scrivens, Accelerated Stability Assessment Program Case Study for a Gelatin Capsule Drug Product Peter O Connell, Cuspor, Ireland Panel Discussion: Use and Implementation of Accelerated Stability Assessment Program Panelists: Dr. Garry Scrivens, Dr. Sabine Thielges, Helen Williams & Ellen Verheyen

6 WEDNESDAY 4 th Ocber 2 08:30 09:00 Registration SESSION 1: PHYSICAL STABILITY CONSIDERATIONS Chair: Dr. John M. Campbell 09:00 09:40 Physical Form Changes (Polymorphism and Disproportionation) Dr. Gregory Stephenson, CrystalPharmatech, USA 9:40 10:20 10:20 10:50 Understanding and managing the risk of physical instability in a challenging drug product design space Dr. Paul Whiteside, Morning Break SESSION 2: OXYGEN RELATED TOPICS Chair: Dr. John M. Campbell 10:50 11:30 11:30 12:10 12:10 12:50 12:50 14:00 Overview of Pharmaceutical Oxidative Degradation Mechanisms Dr. Steven W. Baertschi, Baertschi Consulting, USA Oxygen sensitivity modelling and packaging implications Dr. Ken Waterman, FreeThink Technologies Inc., USA New type of oxygen scavenger for pharmaceutical packaging Prof. Zenon Foltynowicz, Poznan University, Poland Lunch

7 SESSION 3: EARLY STAGE STABILITY STRATEGIES - I Chair: Dr. Greg Stephenson 14:00 14:40 Degradation Mechanism Elucidation: A Case Study in Product Dr. John M. Campbell, Ph.D. GlaxoSmithKline, USA 14:40 15:20 15:20 15:50 Drug Excipient Interactions: The Effect of Drug Load and Humidity on Degradation Rate Dr. Garry Scrivens, Afternoon Break SESSION 4 - EARLY STAGE STABILITY STRATEGIES - II Chair: Dr. Greg Stephenson 15:50 16:30 16:30 17:10 17:10 18:45 Designing Stable Formulations Dr. Thomas Andersson, AstraZeneca, Sweden Applications of Predictive Stability in Early Development Helen Williams, AstraZeneca, UK Social

8 THURSDAY 5 th Ocber 3 08:15 08:45 Registration SESSION 5: PREDICTING STABILITY FOR SOLUTIONS & STABLE PRODUCTS Chair: Helen Williams 08:45 09:25 09:25 10:05 10:05 10:35 Prediction of Solution Phase Stability Dr. Garry Scrivens, Justifying shelf-lives when no degradation observed at accelerated conditions Dr. Kenneth C. Waterman, FreeThink Technologies Inc., USA Morning Break SESSION 6: MISCELLANEOUS Chair: Helen Williams 10:35 11:15 11:15 11:55 11:55 12:35 Electrochemical degradation approach for forced degradation studies Dr. Jean-Pierre Chervet, Newest Regulary Experiences - IQ risk-based predictive stability update Dr. Elke Debie, Janssen Pharmaceuticals, Belgium Dr. Ellen Verheyen, Janssen Pharmaceuticals, Belgium Drug excipient interactions in the solid state: The role of different stress facrs Dr. Amrit Paudel, Research Center Pharmaceutical Engineering (RCPE), Austria

9 12:35 13:40 Lunch SESSION 7: PREDICTING STABILITY - UNDERSTANDING STATISTICS AND HUMIDITY Chair: Steve Baertschi 13:40 14:20 14:20 15:00 Stability Prediction Modelling - Statistics Considerations Jonathan Bright, Statistician, AstraZeneca, UK Humidity Measurement in Stability Testing Applications - Robin Farley, MBW Calibration, Switzerland 15:00 15:30 Afternoon Break SESSION 8: STABILISING AMORPHOUS FORMULATIONS AND DEFORMATION OF MESOPOROUS MATERIALS Chair: Steve Baertschi 15:30 16:10 16:10 16:50 16:50 17:00 Stabilising amorphous formulations: Characterising the mechanisms that control the stability of disordered pharmaceutical materials Dr Paul G. Royall, King s College London, UK Water vapor adsorption induced deformation of mesoporous materials Dr. Juergen Adolphs, Porotec, Germany Closing Remarks