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Prelimenary Program: Day 2 - 18 June 2010

posted Apr 8, 2010 6:15 AM by EBF European Bioanalysis Forum
18-Jun-2010
     
08:30 - 10-00 Challenges and potential of the use of DBS in Clinical Pharmacology
       scope of the session:   
This session will be a forum for all those who are dealing with DBS in the clinical environment covering various topics such as logistic aspects of DBS sampling, storage and shipping as well as routine application of DBS for drug monitoring and paediatric diagnostics, or for clinical studies. The aim of the session is to share experiences and discuss the challenges and advantages of DBS in the clinical setting. The presentations in this session, as scheduled below, will be followed by a panel discussion
     
8:30 - 8:50  invited speaker  
8:50 - 9:05  oral presentation  
9:05 - 9:20  oral presentation  
9:20 - 9:35 oral presentation  
9:35 - 10:00  panel discussion  
     
     
10:30 - 10:30 Break  
     
     
10:30 - 11:30 Overcoming regulatory & QA hurdles for DBS studies and programs.
       scope of the session  
As the industry continues to progress with Dried Blood Spots as an analytical technique for Discovery, Toxicokinetic and Clinical studies, the implications of this change reach far beyond the bioanalytical realm. With the potential for changing from plasma to blood TK/PK data part way through a compounds development, the regulatory implications need due consideration. In addition, as with the introduction of any novel approach, the Quality Assurance aspects around Dried Blood Spots also requires adequate discussion.
The aim of this session is to raise the awareness of the challenges DBS brings with regard to regulatory submissions and QA, and to encourage audience interaction in identifying and overcoming potential hurdles. The presentations in this session will be followed by a panel discussion
10:00 - 10:20  plenary speaker  
10:20 - 10:35  oral presentation  
10:35 - 11:30  panel discussion  
     
     
11:30 - 11:30 Break  
     
     
12:00 - 13:30 Tutorial break-outs - getting to know more details on all aspects DBS
  hosted by key opinion leaders/experts  
     
  topics are being identified  
     
  sandwicheds/light lunch will be provided  
     
     
13:30 - 14:30 Closing Panel Discussion  
     
     
14:30 adjourn