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Clinical trials directive: five years on

 
  November 11, 2008  
     
 
Royal Pharmaceutical Society of Great Britain, London
Thursday 5 March 2009


09.30     Registration and coffee

10.00     Introduction
Dr Ray Munden, Chairman,
Joint Pharmaceutical Analysis Group

10.05     Quality of clinical trial applications
Dr Elaine Godfrey and Dr Martin O’Kane, Pharmaceutical Assessors, Clinical Trials Unit, MHRA, UK 

10.55     CTD five years on: an industrial perspective Dr Julie L Williams, Pfizer,UK

11.30     Common inspection findings on IMP sites
Richard Funnell,
Senior MHRA Inspector, Inspection Division, MHRA
 

12.05               Experiences of an IMP QP at an IMP outsource provider
Paul Graham, Quality Director, SCM Pharma Ltd
 

12.40     Lunch, Exhibition and Poster viewing ** 

13.40     39th Annual General Meeting for JPAG members 

14.10     Experiences of an IMP Qualified Person at a big pharma R & D siteDr Eva-Maria Borchert, R&D Quality and Compliance Northern Europe Regional Manager, Sanofi-Aventis 

14.45     MCRN presentation on the provision of CT suppliesTony Nunn, Associate Director, Medicines for Children Research Network, University of Liverpool 

15.20     The sponsor’s experience
Speaker to be confirmed
 

15.55     Panel discussion

              Speakers and invited panellists

 

16.25     Closing remarks Dr Ray Munden 

16.30 Close

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

Dr Elaine Godfrey and Dr Martin O’Kane, Pharmaceutical Assessors, Clinical Trials Unit, MHRA, UK

 

Dr Julie L Williams, Pfizer,UK

 

Richard Funnell, Senior MHRA Inspector, Inspection Division, MHRA

 

Paul Graham, Quality Director, SCM Pharma Ltd

Dr Eva-Maria Borchert, R&D Quality and Compliance Northern Europe Regional Manager, Sanofi-Aventis

 

Tony Nunn, Associate Director, Medicines for Children Research Network, University of Liverpool
 
 
 
Deadline for Abstracts: Friday 13 February
 
Registration: 09.30          Registration and coffee
E-mail: science@rpsgb.org
 
   
 
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