Global Communications

October 30, 2014

Diane Paskiet to Speak at E&L Europe 2014

Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.
Diane serves as chair of the Product Quality research Institute (PQRI) Parenteral and Ophthalmic Drug Product  Leachables and Extractables Working Group and will present the objectives of the group and application of Thresholds and Best Practices to Prefilled Syringe components at a session on Tuesday, November 11.  PQRI extractables data from common packaging materials and toxicological assessments will also be displayed.

The conference will include presentations on:

  • The European Regulatory Perspective
  • Case studies of E&Ls in infusion pump systems and pre-filled syringes
  • Extractables and Leachables testing – The BioPhorum Operations Group protocol
  • Extractable and Leachable studies of a Pre-filled Syringe (PFS) used for delivery of a cancer-treatment drug solubilized with high content of castor oil surfactant and alcohols
  • Comparison of methodologies for extractables assessment
  • Elemental impurities from materials used in pharmaceutical applications
  • And more!

To learn more or register to attend, visit: http://www.eandl-conference.com/extractables-and-leachables.aspx