Extractables and Leachables USA 2017

9th - 11th May 2017

Falls Church, VA

Extractables and leachables examination is continuously growing in importance. Given the current scruitny paid by governing bodies including the FDA and EMEA, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays.

The knowledge gained at E&L USA 2017 is invaluable, it is the key meeting place for pharmaceutical professionals to discuss best practice in the field of extractables and leachables. 

Overview

Extractables and leachables examination is continuously growing in importance. Given the current scruitny paid by governing bodies including the FDA and EMEA, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays.

The knowledge gained at E&L USA 2017 is invaluable, it is the key meeting place for pharmaceutical professionals to discuss best practice in the field of extractables and leachables. 

2016 speakers included the FDA, Agilent Technologies, GSK, Clariant, Toxikon, AbbVie, Baxter Healthcare and many more. See the full list of speakers here.

Key highlights of 2016:

  • The role of E&L testing in packaging materials for medical devices and pharmaceuticals
  • The latest testing updates and risk assessment case studies for e-cigarettes
  • Best practice for extractables & leachables testing
  • Updates on a number of compelling case studies from Toxikon, Sanofi Pasteur, NIBRT & Aspen Research
  • Future expectations for extractables & leachables

Find out more

Workshop

Leachable Risk Assessment: A Structured Approach To Meet Regulatory Expectations

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 will be sent 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 run from 09:30 – 17:30 and will include 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.

Tickets for the workshop are $899 in addition to your conference ticket*. 

Click here to find out more and book your ticket

*Places on the workshop are limited so book early to avoid missing out. Your attendance at the workshop is subject to approval by the facilitator(s) and you must have booked a ticket to the 2-day E&L USA 2017 conference to be eligible to attend.

Agenda

Here is a snapshot of what to expect at E&L USA 2017:

Regulatory update - FDA 

E&L and the Biocompatibility question – What’s Up? - Dr. Cheryl Stults | Principal of C&M Technical Consulting

In-Vitro toxicological evaluation of materials: The potential of using an AMES assay for the assessment of the mutagenic risk of extractables from the development of pharmaceutical containers Peter Cornelis, Study Director, Toxikon

A Comprehensive Analytical Workflow for the Qualitative Assessment of Extractables and Leachables - David Weil | Senior Application Scientist of Agilent Technologies

Interactions between leachables and pharmaceutical drug products – a myth or a fact? - Carsten Wors√łe | Principal Scientist Extractables and Leachables of Novo Nordisk

Analytical assessments of degraded polymer products after Gamma sterilization and differences of extractables between before and after sterilization - Motoshi Onoda, Research Chemist, Toray Research Center 

Click here to view the full programme >>    

Venue & Info

Westin Tysons Corner | Falls Church, VA

7801 Leesburg Pike
Falls Church
VA 22043
T. +1 (703) 893-1340
W, http://www.westintysonscornerhotel.com/


We have rooms blocked from May 8-12 at the discounted rate of $209 per night plus tax. Delegates can also take advantage of the discounted rate 3 days pre and post the room block dates.

To take advantage of the rate, delegates must book before 17 April 2017. 

Find out more

Pricing

  Standard
Ends 28/04/2017
Final Rate
Runs until event

E&L USA 2017
(2 day conference)

$1,549.00 $1,699.00

E&L USA 2017
(Academic/Government rate)

$774.50 $849.50

E&L USA 2017
(Pre-conference workshop)

$899.00 $899.00
  • Prices expire at midnight GMT.
  • Discount codes and special offers can not be applied retroactively to bookings once payment has been processed.
  • Pricing for the academic and government rate is phased alongside the conference pricing. To take advantage of this rate, please contact Emma Newton at enewton@smithers.com directly with proof of status. Academic status means that you are employed by an institution whose primary activity is education.

Book your place at E&L USA 2017 now!

Sponsor or Exhibit

Sponsoring or exhibiting at E&L Europe is the perfect opportunity to get your company in front of the people who count, generate new business leads in the process and nurture those all important relationships.

Why sponsor or exhibit at Extractables and Leachables USA 2017?

  • Sponsorship and Exhibition packages are one of the most effective mediums for establishing and maintaining customer relations.
  • Gain unrivalled marketing exposure through email campaigns, online via the official event website and in any event literature promoting the conference.
  • Unlike magazines and direct mail, exhibiting involves a two-way communication process. Exhibitors achieve face to face communication - the most effective way to build and sustain customer relations.
  • Position yourself ahead of the competition by showcasing your brand and products with senior level representatives
  • Have the exclusive chance to build up rapport, with direct access to high profile industry experts and organisations with invaluable networking opportunities in a social and enjoyable environment
  • Sponsorship and Exhibition packages provide a highly flexible environment in which a wide range of sales and marketing objectives can be achieved.
  • Gain real life colour and perspective from a wide range of expert presentations from both inside and outside the industry.

Other opportunities include networking break sponsorship, drinks reception sponsorship and sponsored item giveaways as well as table-top exhibition space.


"I want to thank the organisers for a well-organized and highly useful E&L conference last week in Vienna. I gained a lot of information and was able to make really useful contacts, both established and new contacts as it were. It is an excellent sign, and a testament to the quality of the meeting, that there is a good mix of new and well-known faces. Most delegates participated actively in discussions both after the lectures and in the breaks and I also got quite a lot of questions/requests at my table-top booth."

K Petersen, Gerstel


For more information about sponsorship or exhibition opportunities at E&L USA 2017, download the sponsorship or exhibition guide or contact Michael Weilacher at mweilacher@smithers.com or +1 (330) 762 7441.