Medicon Valley Alliance and Smithers would like to welcome you to a Good Morning Meeting 14th of April 2026.
Extractables and leachables remain a critical component of product quality and patient protection across pharmaceutical, biotech, and combination products. This session provides a practical overview of E&L fundamentals, recent regulatory developments, and the evolving expectations shaping study design and documentation. It will also explore how structured program management and clear cross-functional communication support efficient timelines and defensible submissions. The discussion includes the implications of ICH Q3E and how impurity guidance continues to influence modern E&L strategies.
The meeting will be moderated by Brian DeRhen.
Date: Tuesday 14th of April 2026
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Extractables & Leachables in 2026: Practical Fundamentals and Regulatory Shifts Amy Johnson – Technical Specialist, Smithers |
| 9:35 | E&L Program Management in Practice: Keeping Science, Teams, and Timelines Aligned Helen Aylott – Senior Project Manager, Smithers |
| 10:05 | ICH Q3E: Bridging Guidance with Material Risk Amy Johnson – Technical Specialist, Smithers |
| 10:30 | Questions & Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Brian DeRhen, Business Development Manager
Brian DeRhen is a Business Development Manager with Smithers looking after the Nordic region along with Ireland where he is based. Brian is a key contact for medical device and pharmaceutical companies with interest in expert-quality E&L testing, medical and combination device functional testing, packaging testing, and materials testing. He has 7+ years of experience in account management for CROs serving medtech and pharma companies. |
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Amy Johnson, Technical Specialist
Amy Johnson is a Technical Specialist at Smithers, with more than six years’ experience in the Chemistry department of the Medical Device Testing division, where she has led and supported a range of Extractables and Leachables (E&L) studies. For over half of her E&L career, Amy served as Principal Scientist within the laboratory team, specializing in LC MS method development and data interpretation. She now brings this expertise to her current role as Technical Specialist, where she supports E&L studies end to end: from initial client consultations, designing studies tailored for each individual client to meet specific technical and regulatory requirements, to report generation and submission support to global regulatory authorities. |
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Helen Aylott, Senior Project Manager
Helen is a Senior Project Manager at Smithers in the Chemistry department, working on Extractables & Leachable projects. Before working at Smithers, she was an organic and medicinal chemist in early-stage drug discovery at Redx Pharma and, previously, GSK. |
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