Event info
Date:04 Jun, 2025
Time:08:30
Venue:Medicon Valley Alliance, Copenhagen

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Contact person
Mia Ritterband-Rosenbaum

Mia Ritterband-Rosenbaum

Event Manager & PA to CEO

mrr@mva.org

+45 21 63 38 88

Navigating the Future of Extractables & Leachables: Staying Ahead of the Curve

Medicon Valley Alliance and Smithers would like to welcome you to a Good Morning Meeting 4th of June 2025.

The assessment of extractables and leachables (E&L) on pharmaceutical products, medical devices, delivery systems, and processing equipment have continued to evolve. This aligns with the expanding exposure of polymeric materials to patients, resulting in the path to addressing E&L becoming increasingly complex. We will examine, current trends and regulatory expectations, effective risk assessment, testing advancements and strategies to overcoming challenges.
This event is for anyone with involvement or interest in E&L and across both R&D and manufacturing. Attendees will learn strategies for addressing relevant challenges from Smithers experts with knowledge in effective implementation and execution of E&L studies.

The meeting will be moderated by Brian DeRhen.

 

Date: Wednesday 4th of June 2025
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2

 

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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 The E&L Landscape: Regulations, Study Phases, and Best Practices
Helen Lewis, Manager of Project Management
9:35 Understanding E&L: Test Programs for Processing Equipment and Packaging
Mehrdad Kadkhodaei, Technical Specialist
10:05 Overcoming E&L Challenges: Identifying Reliable Solutions
Helen Lewis, Manager of Project Management
Mehrdad Kadkhodaei, Technical Specialist
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.
Helen Lewis, Manager of Project Management

Helen manages the Project Management team at the Smithers cGMP E&L testing laboratory in the UK.
With over 26 years of experience in Extractables and Leachables, Analytical Chemistry, and E&L Regulatory Support across the US and Europe, Helen’s expertise is founded in a variety of analytical chemistry, including: method development, method validation, and identification using a variety of instrumentation.
Currently, Helen leads the E&L experts at the Smithers E&L testing laboratory. The Smithers team offers E&L testing and effective program management to the medical device, pharmaceutical, and biopharmaceutical industries to fulfil regulatory compliance. The team’s activities encompass performing and managing material characterisation, pharmacopeia testing, E&L testing, toxicity assessments, and submission preparation.
Mehrdad Kadkhodaei, Technical Specialist

Mehrdad holds a master’s degree in ‘Drug Discovery’. Since his graduation in 2014, Mehrdad has held various positions within science industries, focused on analytical chemistry.
At Smithers, Mehrdad is responsible for the provision of technical leadership for the design and delivery of multiple staged Extractable & Leachable study packages in accordance with guidelines and GMP standards.

 

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