Device and Container Testing for Pharmaceutical Products – A CRO Perspective
Medicon Valley Alliance and Smithers would like to welcome you to a Good Morning Meeting 26th of November 2025.
Design verification of combination pharmaceutical–medical devices is a critical step in ensuring regulatory compliance and product performance. This seminar on parenteral delivery systems explores best practices for developing robust strategies, aligning with regulatory requirements, and testing under representative use conditions.
Attendees will gain insights into selecting appropriate test methods, understanding device classifications, and applying risk-based approaches to validation planning.
The meeting will be moderated by Brian DeRhen.
Date: Wednesday 26th of November 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 |
Design Verification Testing – Requirements and Best Practices
Michael Zier, Laboratory Operations Manager |
| 9:35 |
Injectables and Parenteral Delivery Systems
Chris Berry, Manager – Medical Device Physical Testing |
| 10:05 |
Capturing the Full Scope of Your Requirements
Chris Berry, Manager – Medical Device Physical Testing |
| 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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Chris Berry, Manager – Medical Device Physical Testing
Chris manages the Medical Device, Physical Testing Laboratory at Smithers cGMP site in Shawbury, Shropshire, UK.
With over 26 years of experience in materials testing and device engineering, Chris’s expertise are founded in medical devices, specialising in drug delivery systems and focusing on product development, design verification testing, failure investigation and testing for batch release.
Chris leads a multi-disciplinary team of experts at Smithers. He and his team provide support to clients across the UK, Europe and the rest of the World. . |
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Michael Zier, Laboratory Operations Manager
Michael manages the latest Smithers Medical Device, Physical Testing laboratory in Frankfurt, Germany.
With over thirty years of industry experience, Michael started as a Laboratory Technician in Chemistry, eventually becoming Laboratory Manager in R&D of pharmaceutical combination products for COPD and Asthma. He has experience and expertise in inhalation device development, analytical test creation and validation, batch release for clinical trials, ATT, supplier re-qualification, and equipment implementation, including transfer of manual methods into automated approaches.
Michael has a wealth of experience in developing and testing of pharmaceutical combination products, including the associated regulatory requirements and international testing standards, to assist in his role as Laboratory Operations Manager.
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