Dr. Andrew Feilden | Chemistry Operations Director of Smithers Rapra
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 of Medicines and Healthcare products Regulatory Agency (MHRA)
Ronald Brown | Toxicologist of U.S. FDA (retired)
Dr. Michael Eakins | Founder and Principal Consultant of Eakins and Associates
Attend the Poster Session in the exhibition hall to find out about cutting-edge E&L science and put your questions to the authors. See the confirmed posters here: https://www.eandl-conference.com/europe/poster-sessions
Andrew Teasdale | Senior Principal Scientist Impurity Management and External Advocacy of AstraZeneca
Andrey Sarafanov | Chemist, Principal Investigator Center for Biologics Evaluation and Research (CBER) of U.S. Food and Drug Administration (U.S. FDA)
Graham Wilson | Senior Manager Extractables & Leachables of Mylan
Rick Reiley | Senior Scientist of GlaxoSmithKline
David Edwards | CMC Scientific Leader of Teva Pharmaceuticals
Ivan Kourtchev, Scientist, GlaxoSmithKline and Ewan Pickard, Principal Scientist, Smithers Rapra Ltd.
Tom Van Wick | Principal Scientist of Abott
Raymond Colton | Founder and President of VR Analytical
Panel lead: Dr. Andrew Feilden, Chemistry Operations Director, Smithers Rapra Ltd.
Panellists: Ronald Brown, U.S. FDA; Melanie Pires, MHRA; Andrew Teasdale, AstraZeneca; Rick Reiley, GSK; David Edwards, Teva Pharmaceuticals
Networking drink reception from 18.10 to 19.40
Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk
Clemens Günther | Director Nonclinical Safety Consumer Care of Bayer HealthCare Pharmaceuticals
Dr. Sherry Parker | Toxicology Director of Fresenius Medical Care
The Working Group for ISO 10993-17 is preparing a new draft of the standard. This presentation will include the following:
Dr. Albrecht Poth | Senior Toxicologist of Dr. Knoell Consult GmbH
Dr. Alexander Koerner | Project Manager - Biocompatibility of Roche Diabetes Care GmbH
Panel lead: Carsten Worsøe, Principal Scientist Extractables and Leachables, Novo Nordisk
Panellists: Alexander Körner, Roche, Albert Poth, Knoell, Clemes Guenther, Bayer. Sherry Parker, Frensenius Medical Care, Ronald Brown, former FDA
Dr. James Stern | Head of Business Development, Healthcare of ALBIS Kft
Hans de Brouwer | Chief Scientist, Healthcare of SABIC
Dr. Armin Hauk | Lead Scientist R&D of Sartorius-Stedim Biotech GmbH