Below is the 2017 Agenda outlining speakers and topics discussed at the 11th Annual Extractables & Leachables conference in Lyon.
Led by representatives from Smithers Rapra and GlaxoSmithKline
The workshop will focus on leachable risk assessment and therefore a pre-read package on the basics of extractable and leachable with send to delegates in advance of this course, enabling the workshop to devote more time on the technical risk assessment process. The workshop is designed to give practical experience of performing a technical risk assessment to evaluate exposure risk to patients from leachables derived from container closure or manufacturing materials and then use extractable and/or leachable testing as risk reduction activities to meet regulatory expectations.
It will consist of a mixture of short presentations and predominately an interactive element performing a risk assessment on a fictitious medical product. The facilitators from Smithers Rapra, Baxter Healthcare and GSK will assist in the workshop and give the presentations.
The presentations will cover the concepts and themes associated with a science led risk based approach to extractable and leachable testing and its close alignment to concepts of quality by design and lifecycle management aligned to guidance of Drug Product Development (ICHQ8) and Quality Risk Management (ICHQ9).
Interactive element will cover:
Risk identification (cause and effect)
Risk evaluation & analysis (knowledge gathering and scoring)
Risk reduction (Extractable and/or leachable testing)
The workshop will cover the entire day and will include a light lunch. Please ensure you include your role in extractables and leachables when booking your ticket so teams can be assigned with a diverse mixture of people.
Please note the workshop will run from 9.30am-5.30pm.
Melanie Pires, Senior Pharmaceutical Assessor, MHRA
Edwin Jao, Branch Chief, FDA
Gilbert Tumambac, Senior Principal Scientist – Regulatory and Validation Consulting Group, Pall Life Sciences
Panellists to be announced!
Greg Erexson | Senior Principal Research Scientist of AbbVie
Lise Vanderkelen | Department Head Pharma Services of Toxikon Europe
Mike Hodgson | Global Extractables & Leachables Senior Manager of Baxter International Inc
Dan Carrier, Applications Laboratory Manager, Anatune and Ivan Kourtchev, Investigator, GSK
Pete Watts | Director of Toxicology of bibra toxicology advice and consulting
Beate Treffler | Regional Head Europe, Segment Healthcare Polymer Solutions of Clariant
Tiru Kumaravel | Chairman of GLR Laboratories
Alan Hendricker | Manager - Chemical Sciences of Becton Dickinson
Matthew Jorgensen, Chemistry and Materials Scientist, Nelson Laboratories
Xiaochun Yu | Principal Scientist of PPD
Anita Sawyer | Biocompatability and Standards Manager of Becton Dickinson
Panellists to be announced!
Thomas Egert | Analytical Development of Boehringer Ingelheim Pharmaceuticals
Malcolm Kimber | Laboratory Operations Director of Hall Analytical Laboratories