Event overview

We're bringing together experts from Element Materials Technology and industry-leading speakers, including Waters™ and Bibra Toxicology Advice & Consulting, to offer medical device and pharmaceutical professionals the opportunity to learn more about how extractables and leachables (E&L) studies are performed, how data is evaluated, the expectations of regulators, and much more.

 

Why attend this event?

Building on the success of our 2023 event, where we witnessed enthusiastic participation and insightful discussions, we are thrilled to welcome you to this in-person event, tailor-made for medical device and pharmaceutical experts seeking to deepen their understanding of extractable and leachable studies. During the event, you will also have the opportunity to tour the laboratory and discuss the technical aspects of E&L studies with our experts.

With limited spaces available, secure your spot now to avoid missing out on this free event. Register below to reserve your place.

 

Event agenda

  • 09:45 – 10:15: Welcome & Coffee
  • 10:15 – 10:30: Introduction
  • 10:30 – 11:00: ‘Navigating the dynamic landscape of E&L guidelines & standards' - Nick Morley, Element Materials Technology
  • 11:00 – 11:30: 'An introduction to toxicological risk assessment of extractables and leachables: key concepts and case studies’ - Chris Waine / Charles Johnson, Bibra Toxicology Advice & Consulting
  • 11:30 – 12:00: Lab tours
  • 12:00 – 12:45: Lunch
  • 12:45 – 13:15: 'Application of extractables data in single-use technologies' - Amie Lovatt, Watson-Marlow
  • 13:15 – 13:45: ‘Cohorts of concern – what makes special case compounds special’ - Mike Ludlow, Element Materials Technology
  • 13:45 – 14:15: ‘Extractables analysis with high-resolution mass spectrometry’ - Rachel Sanig, Waters™
  • 14:15 – 14:45: Q&A
  • 14:45 – 15:00: Close 

Rachel Sanig, Senior Scientist - Waters™

Rachel received a 1st Class Masters and BSc (Hons) in Chemistry from the University of Leeds. She joined waters as an applications scientist in 2016 and is experienced across clinical and pharmaceutical markets areas using a range of LC-MS analysis techniques. She joined the Chemicals and Materials team in 2018, where she worked as a senior scientist in the areas of impurities, extractables and leachables, and materials research with experience on a range of instrumentation including, IMS QTof, HPLC, and pyrolysis-GC-MS. She is also currently studying for a PhD in recycled plastics analysis. 

 

Chris Waine, Principal Toxicologist - Bibra Toxicology Advice & Consulting

Chris is a Principal Toxicologist at Bibra toxicology advice & consulting, with 11 years’ of experience in human health hazard and risk assessment of chemicals. Along with his work on extractables and leachables, he specialises in the evaluation of pharmaceutical impurities, submissions under the EU REACH Regulation and the application of (Q)SAR models for toxicology. He is a member of the BSI and ISO Technical Committees relating to ISO 10993 on the biological evaluation of medical devices.

Qualifications: Chris has a Masters in Chemistry with Forensic Science, is a Chartered Chemist and an RSB/BTS European Registered Toxicologist

 

Charles Johnson, Toxicologist - Bibra Toxicology Advice & Consulting

Charles has been a toxicologist at Bibra toxicology advice & consulting for 9 years (5 of which as a Senior Toxicologist) . A significant proportion of his time involves the toxicological assessment of extractables and leachables derived from various products including medical devices, pharmaceutical packaging and e-cigarette products on a daily basis.

Qualifications: Charles has a Masters in Chemistry and is an RSB/BTS European Registered Toxicologist

 

Mike Ludlow, Market Development Manager, Element Materials Technology

Learn more on Mike's bio page.

 

Nick Morley, Principal Scientist, Element Materials Technology

Learn more on Nick's bio page.

Additional event details

The event is scheduled to take place from 10am – 4pm, on Thursday June 20th at our Manchester facility: Element Materials Technology, Waterside Court, 1 Crewe Road, Wythenshawe, Manchester, M23 9BE. View location on Google Maps.

Free parking is available on site and lunch and refreshments will be provided.

Learn more about Manchester Life Sciences.

 

Register below

Related Pages

Pharmaceutical Testing Extractables and Leachables

Extractables and Leachables Studies

Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.

Read More
510k-submission-mechanical-testing

Medical Device Testing

As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.

Read More
pharmaceutical testing

Pharmaceutical Testing

Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.

Read More
IS0 18562-2

ISO 18562 Testing: Biocompatibility Analysis

Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.

READ MORE
USP 665 Testing

USP 665, 1665 and BPOG Services

Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.

READ MORE
Pharmaceutical raw materials testing

Excipient Raw Materials and Container Testing

Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.

READ MORE
Connect with Element Life Sciences.

Chemistry, Manufacturing, and Controls (CMC) Consulting Services

We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.

Read MORE
Connect with Element Life Sciences

ICH Stability Testing of Pharmaceuticals and Biologics

We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, ANDA, and NDA approvals of small and large molecule drugs. 

Read more

Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.