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STABILITY TESTING OF PHARMACEUTICALS

  
  August 18, 2008

Others

  
     
 
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

 

 		 
 
Organized by: Royal Pharmaceutical Society of Great Britain
Invited Speakers:

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

 
 
Deadline for Abstracts: N/a
 
Registration: 8am
E-mail: science@rpsgb.org
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