In Review: E&L USA Exceeds Expectations
UK-headquartered plastics experts Smithers Rapra hosted E&L (Extractables and Leachables) USA in early May at the Omni Providence hotel in Rhode Island. Over 85 delegates attended, representing 64 companies from across 13 different countries.
By all accounts the conference was the best event to date. With a huge audience beating last year's record attendance, and a very strong speaker line up, the feedback below speaks for itself.
The organisers extended a big thanks to the audience and conference advisory board—Dr Andrew Feilden, Sukhy Toot, Dr William Beierschmitt and Dr Daniel L. Norwood. The conference was well received. The organisers say they are looking forward to working to further enhance the conference experience for 2014.
Sukhy Toot of Smithers Rapra summarised the highlights of the discussions as follows:
Various working groups presented critical updates to definitions of what extractables and leachables are and associated safety thresholds, with Product Quality Research Institute (PQRI) and new USP guidance to emerge over the next 12-18 months.
Delegates learned about the manufacturing processes of materials and the many ingredients they are comprised of, and hence the various sources of potential leachables and it was shown that the correlation of leachables to extractables serves as a useful confirmatory exercise.
A number of case studies were presented for different products, medical devices and single use systems.
Discussions highlighted that as developments and learning continue with Parenteral and Ophthalmic Drug Products (PODPs), E&L remain key to product and patient safety.
It was also clear that risk assessments with sound justifiable science provide a valuable guidance and decision making pathway to ensure the right and required testing is completed for a successful regulatory submission.
What delegates thought of this year's E&L USA: 99% rated the conference as excellent or above average; 100% of delegates met exactly who they were looking to meet; over half of attendees generated new business and connections; 91% rated the workshop as excellent or above average; and 92% of workshop attendees would recommend to a colleague.
Testamonials are as follows:
"E&L speakers experience, discussions and questions were very interesting" Jason Heimsoth, ABC Laboratories; "Great conference - relevant topics and case studies coupled with lively discussion" Bobbijo Redler, Merck & Co; "Really good knowledge sharing and debates" Robert Broley, TEVA; and "I am able to walk away with a deeper understanding of both E&L studies as well as the toxicological assessment of E&L study results" Ross Acucena, EMP Millipore.
E&L Europe will take place in London on December 10-11, 2013. Sam Anson will attend the conference and looks forward to meeting readers there.