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Learning Lab

Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
10:10 - 10:40 Stand L30
Learning Lab
Director E&L Services
Nelson Labs Europe

Sponsored by:

• Key success factors of any given E&L project on pharmaceutical packaging systems will be highlighted.
• Requirements that global regulators (EMEA and FDA regulators) are expecting of an E&L study design for submission.

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Connected Pen Injectors: Creating a Real Value in Clinical Trials
10:50 - 11:20 Stand L30
Learning Lab
Chief Innovation Officer
Haselmeier

Sponsored by:

Two topics have been constantly keeping our medical device community busy, in particular in the drug injection field: how to offer a true device platform, usable across different drug families and therapeutic areas, combined with the discussion around value of data generated by connected devices. It is broadly accepted that a true device platform should enable to reduce development time and overall time-to-market, regulatory risk, costs and Capex. We believe that such platform should also be able to accompany a drug throughout its entire lifecycle, from early-stage clinical trial to lifecycle management of a mature drug product. In addition, gearing up such device platform with connectivity, sill today raises the question of the value of the generated data. The “lots-of-data-makes-it-all” approach may be an approach worth to try but does still not answer the question of the real value of generating data and information. We believe that focusing a connected solution, generating data, on a simple use case, such as clinical trials, may provide a faster response for a sustainable and proven value proposition for connected device solutions.

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On-Demand Packaging including pre-serialisation
11:30 - 12:00 Stand L30
Learning Lab
Founder & CEO
Graphic West

Sponsored by:

  • Optimizing the Supply-Line of Secondary Packaging
  • On Demand Fast Delivery Time
  • Near-Site/On-Site Production
  • Late stage customizing
  • Pre-serialisation

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Sustainable Sterilization Processing: Investing in X-ray and E-beam
12:10 - 12:40 Stand L30
Learning Lab
Sales Manager DACH
STERIS AST

Sponsored by:

  • STERIS is investing globally in growing their network of sterilization facilities.
  • Additional E-beam capacity added in Malaysia and USA.
  • X-ray processing to be available in the Netherlands, USA and south-east Asia.
A seamless transition from Clinical to Commercial Packaging
12:50 - 13:20 Stand L30
Learning Lab
Associate Director, Technical Operations – Europe
PCI Pharma Services
Vice President, Commercial Packaging – Europe
PCI Pharma Services

Sponsored by:

  • The critical interdependencies between materials, design and process during early stage packaging design
  • The benefits of simplifying the transition from clinical supply to the critical launch phase
  • The key considerations needed when choosing an outsourcing partner for implementing a successful transition
Rethinking DPI Packaging: New Solutions to Old Challenges
13:50 - 14:20 Stand L30
Learning Lab
Vice President, Business Development EMEA
Aptar CSP Technologies

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Dry Powder Inhalers (DPIs) have long faced challenges in terms of the robustness of management of active packaging. Active pharmaceutical ingredients (API) delivered in capsule-based DPIs can be subject to moisture and oxygen causing degradation of the API and ultimately impacting patient therapeutic efficacy. Three-phase polymer technology offers unique protection from residual moisture and ingress through the package. This presentation will explore the application of Aptar’s proprietary three-phase polymer™ technology in managing headspace, moisture and oxygen. It will also review a case study on a reservoir DPI, utilizing all three-phase polymers.
 

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Accelerating and de-risking your drug development journey
14:30 - 15:00 Stand L30
Learning Lab
President
Next Breath, an Aptar Pharma Company

Sponsored by:

We are witnessing an escalation in the complexity of the registration process and a heightened focus on device technology and patient safety from regulatory bodies. Many of these initiatives are driven by FDA’s Combination Drug Product Guidances. This coupled with the limited technical skills expertise in pharma companies, has resulted in a gap in the analytical capabilities required to accelerate and de-risk drug development. To address these gaps, Aptar Pharma Services builds on Aptar’s established credentials together with the expertise of Nanopharm, Next Breath and Gateway Analytical, to support customers during the entire life cycle of the drug product and deliver them a complete solution.

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Inhaler Devices and the Environment: Going Green Needn’t Cost the Earth
15:10 - 15:40 Stand L30
Learning Lab
Director Business Development, Prescription Sales and Operations Europe
Aptar Pharma

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The noise generated around reducing the carbon footprint of industrial products has grown from a local whisper to a global symphony, this growing commitment to our environment could now impact the future of our medicinal products. Inhaler devices have been subject to close environmental scrutiny before, resulting in the transition from CFC to HFA propellants in 2008 to combat the threat of ozone depletion. Today we face a new challenge of global warming. So, where are we today? Where do we need to be tomorrow? We will explore where next for MDIs & HFA propellants, review the alternatives available and discuss the opportunities and solutions for the future.

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Diabetes & Respiratory: ready for device connectivity
15:50 - 16:20 Stand L30
Learning Lab
Business Development Director
BIOCORP

Sponsored by:

• Quick introduction on connected drug delivery devices: categories, benefits, trends, key applications
• Zoom on 2 markets with very mature ecosystems, ready to welcome connected drug delivery devices: diabetes and respiratory
 

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