2019 The Universe of Pre-filled Syringes and Injection Devices (young professional) - Kongress / Konferenz von PDA Europe gGmbH

Inhalte

• Regulatory & Technology Highlights• Digital Health: Design for the Behavior You Would Like to See• Drug-Device Combinations in the EU: An Update• Challenges and Opportunities of Developing a Self-Injectable Platform for Global Health Applications• Delivery Device Development in Midst of an Evolving Landscape of Novel Drug Modalities, Patient Centered Design and Digital Health• Life-Cycle Management of Combination Products• Larger Injection Volumes, Longer Injection Times – Where are the Users' Limits with Handheld Devices?• Human Factors Perspectives on Leveraging a Platform Technology• Practical Pathways for Human Factors Regulatory Compliance for Parenteral Products• Business Case and Journey of Launching a Biosimilar in a Polymer Prefilled Syringe in the International Market• Polymer Prefilled Syringes and Cartridges - Process Technology Development and Handling Aspects for Successful Fill-And-Finish• Excipients Effects on Functionality of Glass and Polymer Based Pre-filled Syringes• An Opportunity to Leverage the Medical Devices Regulation (MDR) Whilst Supporting a Broad Innovative Portfolio in Pharma• Impact of MDR Article 117 on Marketing Authorization Applications for Pre-filled Syringes•  MDR Article 117: Notified Body Opinion Interpretation and Implementation• MRI Clinical Imaging of Human Subcutaneous Injections Up to 10ml in the Abdomen, Thigh and Arm• Evaluating Formulation and Device Factors on Subcutaneous Administration• Evolving Component Technologies to Meet the Needs of Cartridge Delivery Applications• Innovations in Manufacturing of Elastomeric Components for Parenteral Packaging Applications• Augmented Reality for Preventive Maintenance • Design Considerations Pertaining to Primary Container Used for Cell Therapy Products• A Science-Based Recommendation of Elastomer Components for Biologic Drugs

SG-Seminar-Nr.: 5335397

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