Home of the world's leading Extractables & Leachables conferences...
An important announcement!
For 2012, iSmithers and Smithers RAPRA are teaming up with Pira International to bring you the best possible European Extractables and Leachables conference. Just one conference, one date, one location, but the combined expertise of the two organisations will deliver a truly world class event, and the only one of its kind.
Don't miss Extractables and Leachables 2012 - 12-13 December, Vienna, Austria
>>For more information about the 2011 events please click here
Also new for 2012! Extractables and Leachables USA!
Coming to Baltimore USA on 15-17 May 2012, this forum will provide a great opportunity for delegates to come together across the other side of the pond to discuss all of the current E&L issues facing the pharma industry.
>>For more information about the US event please click here
Call for papers
Pira International and Smithers Rapra are recruiting papers from experts and companies that have established best practice in the field of extractables & leachables. By presenting a paper at this conference, organisations can ensure that their name is firmly positioned at the forefront of E&L activity and have the opportunity to present to all parts of the pharmaceutical supply chain.
If you would be interested in speaking at this inaugural event, please send a proposed paper title and a short abstract to Hayley Marsden, at hayley.marsden@pira-international.com by the deadline of 3 February 2012
Here's what some of the delegates thought of the 2011 events:
"It was an informative overview, broad range from supplier to end user, a very interesting meeting", Veren Proell, Croma Pharma
"Relevant discussions and networking", John Lennon, Becton Dickinson
"The academic level of the speakers was very satisfying and the social event in Rome was excellent", Jeanette Dan Moller, Novo Nordisk A/S
"Excellent forum for understanding the current issues on L&E"
"Very interesting conference, good content and well organised"
"Very good mix of presentations from pharma, from regulators, from CROs and from vendors," Renaud Janssen, Daetwyler Group
Join the Smithers Rapra Extractables and Leachables Linked In group to share and discuss ideas about the analysis of extractables and leachables in medical devices...view link
Key Speakers in 2011
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Over 5 years experience (2006-2011) as non-clinical assessor in two regulatory National Competent Authorities (previously at AEMPS in Spain, and currently at MHRA in UK), dealing with the toxicological assessment of extractables and leachables in the applications for marketing authorisation and variations of human medicinal products, among other responsibilities.
Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In his 10 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development.
Michael Creese is a Senior Consultant at Smithers Rapra and has been supporting a variety of customers for extractables and leachables from pharmaceutical process equipment and packaging for 8 years. In 2008 he joined Smithers Rapra and has been working in a team supporting regulatory testing and plastic consultancy on design and material selection in different regulatory environments.
Dr Laschi has been with Sanofi Pasteur since 1997 in the Quality Control department, responsible at first for an analytical laboratory and then for the implementation and the management of the stability unit. Today, she is in charge of the definition of the stability policy of the company, including extractables and leachables analyses and she's involved with the drafting of manuals and guidance regarding the control of the stability of the vaccines, the cold chain break and the container-content compatibility.