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 overwhelming success of our 2023 event, which was marked by enthusiastic participation and insightful discussions, we are excited to invite you to this in-person event. Tailored specifically for experts in the medical device and pharmaceutical fields, this event offers a unique opportunity to:

  • Gain In-Depth Knowledge: Learn how E&L studies are performed, how data is evaluated, and what regulators expect.
  • Engage with Experts: Tour our state-of-the-art laboratory and discuss the technical aspects of E&L studies with leading specialists.
  • Network and Collaborate: Connect with industry peers and thought leaders to share insights and foster collaborations.

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


Register below

  • 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 (lunch and refreshments will be provided)
  • 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 

Amie Lovwtt, Validation Specialist - Watson Marlow Fluid Technology Solutions (WMFTS) 

Amie graduated Keele University with a BSC (Hons) in Chemistry before working at Thermo Fisher Scientific. As a Clinical Trial Specialist, she spent several years in generating clinical trial data and submissions to launch new IVD devices into the market. Amie has more recently become a Validation Specialist for Single-Use Technologies at Watson Marlow Fluid Technology Solutions (WMFTS) where she provides validation testing expertise. 


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


Rachel Sanig, Senior Scientist - Waters™

Rachel Sanig 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. 


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.

Our speakers

Mike Ludlow

Market Development Manager - Element Materials Technology

Amie Lovatt

Validation Specialist  - Watson Marlow Fluid Technology Solutions (WMFTS) 

Chris Waine

Principal Toxicologist - Bibra Toxicology Advice & Consulting

Charles Johnson

Toxicologist - Bibra Toxicology Advice & Consulting

Nick Morley

Principal Scientist, Element Materials Technology

Getting to the event

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.

Learn more about Manchester Life Sciences.

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