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Royal Pharmaceutical Society, Moller Centre, Cambridge, UK
Monday 21 - Wednesday 23 February 2011
Day One - Monday 21 February| 08.00 | | Registration and coffee | | 09.00 | | Introductions
Kevin Ryan, Pfizer R&D and Andy Rignall, AstraZeneca R&D | | 09.15 | | Setting the scene
Kevin Ryan, Pfizer R&D | | 09.45 | | Using chemical knowledge to avoid stability issues – The chemical basis for the stability testing of pharmaceuticals
Andy Rignall, AstraZeneca R&D | | 10.45 | | Coffee and discussion/ networking opportuinity | | 11.15 | | Characterising materials with respect to physical stability
Paul Royall, King’s College London | | 12.15 | | Lunch | | 13.15 | | Healthcare packaging that is value-based
Thomas Dries, Honeywell | | 13.45 | | Predicting stability issues -
Purposeful degradation studies and the development of stability-indicating methodology
Andy Rignall, AstraZeneca R&D | | 14.15 | | Practical aspects of stability testing
Gerry Maxwell, NDA Analytics | | 15.15 | | Coffee and discussion/ networking opportuinity | | 15.45 | | Interactive workshop: the stability of ‘profragilazone’
- analytical & formulation development strategies
Andy Rignall, AstraZeneca R&D and Gerry Maxwell, NDA Analytics | | 16.45 | | Interactive workshop: teams feedback and group discussion
Andy Rignall, AstraZeneca R&D and Gerry Maxwell, NDA Analytics | | 17.30 | | Close of day | | 18.45 | | Welcome reception | | 19.30 | | Dinner and table debates |
Day Two - Tuesday 22 February| 08.30 | | Physical aspects of product stability
Graham Leonard, GSL Pharma Consulting | | 09.30 | | Stability testing of pharmaceutical delivery devices
Dave Johnson, AstraZeneca | | 10.30 | | Coffee and discussion/ networking opportuinity | | 11.00 | | Stability testing of biotechnology products
John Smith, Lonza Biologics | | 12.00 | | Lunch | | 13.00 | | Product packaging and stability: an overview
David Pethick, DPPK Consulting | | 14.00 | | Show and tell – examples of packaging failures/ fixes
David Pethick, DPPK Consulting | | 14.30 | | Workshop on devising appropriate development clinical stability protocol
Kevin Ryan, Pfizer R&D and Dave Johnson, AstraZeneca | | 15.30 | | Coffee and discussion/networking opportunity | | 16.00 | | QBD for stability and accelerated stability assessment program :
using science to set shelf life
Garry Scrivens, Pfizer | | 17.00 | | Stability testing - the uk and european regulatory perspective
Paul Marshall, Medicines and Healthcare products Regulatory Agency | | 18.00 | | Open forum - round table discussion
Paul Marshall, Medicines and Healthcare products Regulatory Agency | | 18.30 | | Close of session | | 19.30 | | Dinner and table debates |
Day Three - Wednesday 23 February| 08.30 | | Statistical interpretation of stability data
Mark Whitlock, Pfizer | | 09.30 | | Registration stability testing for product
Kevin Lord, GSK
| | 10.30 | | Coffee and discussion/ networking opportuinity | | 11.00 | | Workshops in parallel session
Kevin Lord, GSK - Workshop 1: Stability testing by Contract Research Organisations
- Workshop 2: Establishment of stability testing criteria
- Workshop 3: Minimal stability study design for worldwide filing
| | 12.30 | | Lunch | | 13.30 | | Feedback and workshop reports | | 14.30 | | Close of course |
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Organized by:
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Royal Pharmaceutical Society |
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Invited Speakers:
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See Programme
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Deadline for Abstracts:
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N/a
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Registration:
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| Member (no accommodation or evening meal): | £1,410.00 | £1,555.00 | | Member of RPS: | £1,700.00 | £1,845.00 | | Non-member: | £1,775.00 | £1,920.00 | | Non-member (no accommodation or evening meal): | £1,485.00 | £1,630.00 |
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E-mail:
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events@rpharms.com
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