Analytical Challenges In E&L To Be Discussed At Extractables And Leachables USA Conference, 7-9 May 2013, Providence, RI
Extractables and Leachables USA 2013 (E&L USA) two day conference is fast approaching. Current registrations have seen a 15% rise in attendee numbers from the successful inaugural event, and with just over a week to go organisers Smithers Rapra are looking forward to a stellar event in May.
In the lead up to the conference Dr Gyorgy Vas, Principal Scientist, Johnson & Johnson discusses challenges faced by pharmaceutical development scientists. “To evaluate medical devices is to find appropriate (biologically relevant) extraction conditions for device testing. Since those devices are exposed to a human environment (mainly aqueous, up to few % organic, pH and ionic strength buffered), the evaluations to solutions have to simulate those conditions. The other challenge is the length of the test period (up to 60 days). Furthermore, medical devices are made from special engineered polymers which usually require special consideration. Testing metal devices can also be challenging.” Dr Gyorgy will be speaking on May 8, addressing product equivalency for medical devices on two case studies.
Dr Alan Hendricker, Catalent Pharma Solutions is another speaker at conference and will address analytical challenges in E&L; he has been looking forward 10 years and explains his findings. “The remaining dosage forms for which extractables and leachables are considered an issue will have best practices in place. These will be based on the OINDP blueprint with customized approaches …” To read the full interview visit http://www.eandl-conference.com/dr-alan-hendricker
Smithers are also pleased to announce Dr Ingrid Markovic, CBER, FDA who will present an insight into scientific and regulatory considerations for extractables and leachables, including real life case studies supporting recommended analytical methods. Coupled with an introduction to E&Ls from Sukhy Toot at Smithers Rapra, the session will expertly set the scene and focus the discussions for the two day conference. Other speakers lined up include Dr Dennis Jenke, Baxter Healthcare. Bill Beierschmitt, Pfizer, and Diane Paskiet, West Pharmaceutical Services
For more information on E&L USA 2013 conference visit http://www.eandl-conference.com/extractables-and-leachables.aspx