Below is the 2016 Agenda outlining speakers and topics discussed at the 10th Annual Extractables & Leachables conference in Dublin.
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View 2016 confirmed speakers >>
Led by representatives from Smithers Rapra, Baxter Healthcare 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:
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.
To find out more: click here.
*Please note, if you register to attend the workshop you will be unable to attend the site visit to NIBRT.
Finishes at 5.30pm.
To celebrate the 10th anniversary of Extractables & Leachables Europe, we'll be visiting NIBRT's Dublin facility. This is the first time ever that a site visit has taken place as part of the E&L Europe conference!
Taking place before the 2-day conference on Tuesday 8th November 2016 from 14:00 - 17:00, this is the perfect way to kick off your Extractables & Leachables conference experience.
As part of the site visit, participants will take part in an interactive tour of the bioprocessing pilot plant, with access to all production areas. This will give visitors a good understanding of the process flow and the equipment involved in the bioprocessing industry.
The site visit will include a light lunch.
To find out more: click here.
*Please note, if you register to attend the site visit to NIBRT you will be unable to attend the workshop.
Finishes at 5.30pm
Andrew Feilden, Chemistry Operations Director, Smithers Rapra and Carsten Worsoe, Principal Scientist Extractables and Leachables, Novo Nordisk
Karin Bracht | Senior Pharmaceutical Assessor of MHRA
Kevin Day | Associate Principal Scientist of AstraZeneca
Malcolm Kimber | Laboratory Operations Director of Hall Analytical Laboratories
Gordon Ross and David Weil, Agilent Technologies
Carsten Worsøe | Principal Scientist Extractables and Leachables of Novo Nordisk
Steven Watts | Business Development Manager of A&M STABTEST
Luke Heaven | Director of Marketing for Fluid Management Technologies of Sartorius Stedim
Jerome Vachon | Lead Scientist in the Materials Science of SABIC
Sigrid Saaler-Reinhardt, Director Corporate Project Management, Midas Pharma with Christopher Weikart, Chief Scientist, Si02 Medical Products
Francois Bianchi | Head of Global Packaging Migration of B.Braun Medical
Alan Hendricker | Manager - Chemical Sciences of Becton Dickinson
Café en Seine, in the heart of Dublin, is one of the city’s most popular drinks and nightlife venues and was voted Dublin’s 2015 City Bar of the Year. The venue is laid out like one big neighbourhood with many vibrant spaces and our drinks reception will be held in The Atrium…a private area on the ground floor. Drinks and snacks will be served for apx 1.5hrs.
It is a 10 minute coach journey from the hotel.
For those making their own way, the address is below:
Café en Seine
39-40 Dawson Street
Pete Watts, Director of Toxicology and Chris Waine, Toxicologist, bibra toxicology advice and consulting
Dr. Dennis Jenke | Chief Executive Scientist of Triad Scientific Solutions
Wolfgang Muster | Toxicology Project Leader of Roche
Glenn Myatt | Chief Scientific Officer of Leadscope
Jessica Shea | E&L Global Technical Services Manager of MilliporeSigma (Merck)
Noemi Dorival Garcia | Postdoctoral Researcher of National Institute for Bioprocessing Research and Training (NIBRT)
Michael Jahn | Head Forensic Chemistry, Drug Product Services of Lonza
Alicja Sobantka | Expert for Material Qualification of Octapharma
Kristina Moller | Scientist of GE Healthcare