Workshops

All times displayed for Europe/Paris timezone.

Impact of Medical Device Regulation on Drug/Device Combinations - are the market players ready?
09:10 - 09:50 Room 725-727
Workshops

• What is the MDR and why are Pharma products affected?
• What is new compared to before MDR
• Status on MDR implementation
• Notified body readiness
• New requirement on drug manufacturers
• Implication on combination product manufacturers / shortage of notified bodies
• Risk on drug product submissions in the EU
• EU vs US comparison on combination product regulation

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Novel Container Integrity Concept for Vials: Use Cases and Concepts for Machine Processability
10:00 - 10:40 Room 725-727
Workshops
Manager Innovation and Strategic Partnerships Healthcare
Schreiner MediPharm
Technical Product Manager
Bausch+Ströbel

Sponsored by:

Container integrity is a major issue within the pharmaceutical supply chain to ensure product and patient safety. The presentation will highlight a new label and cap security concept that reliably seals the container to meet the danger of product tampering, while also helping to protect against glass breakage and surface contamination. To ensure smooth processability of the label and cap solution, new modular machine concepts will be introduced that fit into existing environments at the pharmaceutical manufacturer.

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The Wearable Injection Device Platform That Works from Clinical Trials to Lifecycle Management
10:50 - 11:30 Room 725-727
Workshops
Business Development Manager
Sonceboz SA

Sponsored by:

• What defines a true wearable device platform?
• Importance of container flexibility • What is possible beyond large volume?
• DFM/DTC approach in drug delivery
• What defines a true wearable device platform?
• Importance of container flexibility
• What is possible beyond large volume?
• DFM/DTC approach in drug delivery

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From Big Data to Smart Data: Extracting, Processing and Analyzing Manufacturing Data for a New Approach to OEE and Business Intelligence
11:40 - 12:20 Room 725-727
Workshops
Product Manager
Antares Vision

Sponsored by:

• Monitoring real-time production lines efficiency
• Optimizing performances and OEE
• Connecting serialization lines and any other equipment
• Improving resource planning and maintenance

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Design Control and Control Strategy - How to reach a state of control for combination product manufacturing and release
12:30 - 13:10 Room 725-727
Workshops
Managing Director
Tengroth Consulting
  • Introduction to Design Control
  • Control Strategy as result of Risk Management
  • Case Study: Pre-Filled Syringe
  • Case Study: Auto-Injector
  • Takeaways

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Polycarbonate Innovations for Next Generation Drug Delivery Devices
14:00 - 14:40 Room 725-727
Workshops
Global Technology Lead, Healthcare
Covestro Deutschland AG

Sponsored by:

Drug delivery devices have taken on increasing sophistication to meet the needs of increasingly tech savvy patients. At the same time, more and more regulatory requirements such as recent revisions to USP661.1 have raised the bar for suppliers in this increasingly competitive arena. This presentation will outline and present examples of how Covestro, a polycarbonate supplier to healthcare for over 50 years, innovates its materials portfolio for healthcare to meet these challenges.
• Key Polycarbonate material properties for new Drug Delivery Devices
• Changing needs and requirements for Drug Delivery Devices (e.g. USP661.1)
• Polycarbonate innovations for Global Drug Delivery Device Manufacturers
• Orienting Drug Delivery Materials toward Circular Economies and New Sustainability Requirements

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Measuring the Value of Improved Workflow Efficiency and Safety of Drug Administration with Prefilled Syringes
14:50 - 15:30 Room 725-727
Workshops
Global Portfolio Lead
Becton Dickinson & Co

Sponsored by:

Understanding hospital and care center’s unmet needs is vital for providing them with impactful solutions. In the healthcare setting, patient safety concerns exist across the entire drug delivery spectrum. Specifically, in an acute care setting where decisions are often made quickly or under stress, error rates can be at their highest. In a healthcare setting, medication errors can result from human factors, work-arounds etc. and may be linked with the type of primary container being used in medication preparation and administration. Collectively, drug delivery mistakes create challenges in maintaining optimal patient safety, healthcare worker safety, and can negatively impact the end user’s bottom line. Through the workshop, we will address how differences in primary container options for injectable drugs can add value by offering care centers configurations that address universal pain points.

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Drive Adherence and Patient Compliance through a Smart Packaging System
15:40 - 16:20 Room 725-727
Workshops
VP Marketing & Product
LOG – Pharma Primary Packaging

Sponsored by:

Low and inconsistent adherence to prescription medicine or supplementation of nutraceuticals is responsible for 33% of medicine-related hospitalizations, an estimated 125K deaths every year in the US alone, and $300B in avoidable costs to the health care system annually. ActiveGuard® CONNECT™ was developed with the goal of addressing the lack of patient adherence with their drug regimen.

Smart Packaging Solutions
• Increase adherence by 23%
• Help to monitor compliance during clinical trials
• Enable direct engagement with the end user
• Empower pharma and nutraceutical manufacturers to improve medication and supplement efficiency

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Feasibility of Large Volume Drug Delivery in Subcutaneous Injections
16:30 - 17:10 Room 725-727
Workshops
Associate Director, Parenteral Sciences COE
Becton Dickinson Technologies & Innovation

Sponsored by:

Current treatment of chronic diseases requires patients to undergo traditional clinical intravenous (IV) administration. The shift of IV to subcutaneous (SC) delivery may provide patients the convenience of in-home self-administration but will require formulations with higher viscosities and volumes. Delivery of higher volumes and viscosities have raised questions about the feasibility of subcutaneous delivery. BD has conducted a series of pre-clinical and clinical trials to demonstrate feasibility of 2-10 mL biologic injections into subcutaneous tissue and characterize the tissue response to those injections in human and animal subjects. This presentation will share the latest results of select studies.

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