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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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August 18, 2008 |
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ROYAL PHARMACEUTICAL SOCIETY OF GREAT BRITAIN, Cambridge
09 – 11 February 2009
Monday 9 February 08.00 REGISTRATION 09.15 INTRODUCTION 09.30 SETTING THE SCENE - STABILITY OF materials we put on or in our bodies
10.00 THE CHEMICAL BASIS FOR THE STABILITY TESTING OF PHARMACEUTICALS
11.15 PHYSICAL ASPECTS OF PRODUCT STABILITY
12.30 Lunch 13.30 PURPOSEFUL DEGRADATION STUDIES AND THE DEVELOPMENT OF STABILITY-INDICATING METHODOLOGY 14.30 INTERACTIVE WORKSHOP: THE INSTABILITY OF ‘PROFRAGILAZONE’ – ANALYTICAL & FORMULATION DEVELOPMENT STRATEGIES 15.30 Coffee and discussion/ networking opportuinity 15.45 INTERACTIVE WORKSHOP: TEAMS FEEDBACK AND GROUP DISCUSSION 16.45 Workshop Session Report 17.00 Close of day 18.00 Welcome Reception 19.15 Dinner Tuesday 10 February 09.00 CHARACTERISING MATERIALS WITH RESPECT TO PHYSICAL STABILITY 10.00 STATISTICAL INTREPRETATION OF STABILITY DATA 11.00 11.00 Coffee and discussion/ networking opportuinity 11.30 STABILITY TESTING OF PHARMACEUTICAL DELIVERY DEVICES 12.45 Lunch 13.45 STABILITY TESTING OF BIOTECHNOLOGY PRODUCTS 15.15 Coffee and discussion/ networking opportuinity 15.30 WORKSHOP ON PRODUCT PACKAGING 16.30 STABILITY TESTING - THE UK AND EUROPEAN REGULATORY PERSPECTIVE 17.30 OPEN FORUM - ROUND TABLE DISCUSSION 18.15 Close of session 19.15 Dinner Wednesday 11 February 08.30 INTERNATIONAL ASPECTS OF STABILITY TESTING FOR PRODUCT REGISTRATION 09.30 WORKSHOPS IN PARALLEL SESSION Workshop 1 Stability Testing by Contract Research Organisations Workshop 2 Establishment of Stability Testing Criteria Workshop 3 Minimal stability study design for worldwide filing 10.20 Coffee and discussion/ networking opportuinity 10.45 FEEDBACK and WORKSHOP REPORTS 11.45 PRACTICAL ASPECTS OF STABILITY TESTING 12.45 LUNCH 13.45 ACCELERATED STABILITY ASSESSMENT PROGRAM (ASAP): USING SCIENCE TO SET SHELF LIFE 15.00 Close of course
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Organized by:
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Royal Pharmaceutical Society of Great Britain |
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Invited Speakers:
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Kevin Ryan, Pfizer Andy Rignall, AstraZeneca R & D Graham Leonard, GSL Pharma Consulting
Paul Royall, King’s College London Sue Smith, AstraZeneca Alison Sykes, Lonza Biologics Roy Gray Sue Harris, Medicines and Healthcare products Regulatory Agency Jon Beaman, Pfizer Gerry Maxwell, NDA Analytics Garry Scrivens, Pfizer
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Deadline for Abstracts:
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N/a
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Registration:
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8am
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E-mail:
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science@rpsgb.org
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