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14-15 September 2010, London


Leachables & Extractables for Pharmaceutical Products 2010 will be looking at the implications of leachables and extractables (L&E) on all tiers of the pharmaceutical supply chain.

With regulatory authorities, like the FDA and MHRA, demanding reassurance that a products integrity has been tested – the pharmaceutical industry has met the call for L&E best practice guidelines with various industry groups working on this important issue.

A variety of industry working groups for example, Orally Inhaled and Nasal Drug Products (OINDP), Parenteral and Ophthalmic Drug Products (PODP), Extractables and Leachables Safety Information Exchange (ELSIE) and Bio-Process Systems Alliance (BPSA), are working towards a common understanding of what L&E testing should be done and at what stage in the supply chain this is most appropriate.

iSmithers is now recruiting speakers for this popular international conference and is particularly welcoming papers on the following topics: 

  • L&E implications on raw material suppliers
  • Converters role in L&Es
  • Drug manufacturers L&E considerations
  • L&E testing
  • L&E quality control
  • L&E impact on medical devices
  • Regulatory organisation L&E expectations
  • Industry best practice
  • N-1, N-2, N-3 case studies
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    Presenting Authors

    Presenting authors at Leachables & Extractables for Pharmaceutical Products 2010 will be entitled to free registration on both days of the conference, including lunches, refreshments and a copy of the proceedings.

    If you are interested in presenting a paper at this event, please sent a title, short summary, speaker name(s) and company name(s) to Alix Reeves email: areeves@ismithers.net or Fax +44 (0) 1939 252416 by the deadline of 19 March 2010


    If you want an introduction to or refresher on the regulatory requirements relating to Extractables & Leachables and the testing methodologies available, join us at Shawbury, on the 25th November on our one day seminar:

     'Introduction to Extractables & Leachables Testing' -

    Short Course at Smithers Rapra Shawbury on 25th November 2009

    http://www.ismithers.net/course-details.php?id=YEXTLCH


     

    Conference Prices

    Register before 30 June 2010 to take advantage of the special Early Bird Discount

    Companies sending one or two delegates

    €799 + VAT at 17.5% per delegate before 30 June 2010

    €1099 + VAT at 17.5% per delegate after 30 June 2010

    Companies sending three or more delegates

    €699 + VAT at 17.5% per delegate before 30 June 2010

    €999 + VAT at 17.5% per delegate after 30 June 2010

     

    Venue Information

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