4th Annual Drug/Device Combination Products Summit
21-22

April 2020

Italy

Rome

Eurostars Roma Aeterna

Via Casilina 125, 00176

About

Welcome to the 4th Annual Drug/Device Combination Products Summit on April 21-22, 2020, in Rome, Italy. Combination products bring together generic or biologic drug and medical devices to more effectively deliver treatments to patients. They are still relatively new delivery systems for the healthcare market. During the past few years new regulations and legal developments have improved the framework for combination product development and evolved the technology. Therefore that process increased technological requirements, as well as quality s...

Welcome to the 4th Annual Drug/Device Combination Products Summit on April 21-22, 2020, in Rome, Italy. Combination products bring together generic or biologic drug and medical devices to more effectively deliver treatments to patients. They are still relatively new delivery systems for the healthcare market. During the past few years new regulations and legal developments have improved the framework for combination product development and evolved the technology. Therefore that process increased technological requirements, as well as quality systems and lifecycle management. This event provides the appropriate platform for industry leaders to discuss the best practices in drug/device combination products development. The Summit will provide a broad overview of guidelines and regulations, market trends and device needs, connected devices and wearables, technologies and innovations, product usability and delivery aspects. We are excited to be hosting the 4th Annual Drug/Device Combination Products Summit and we look forward to meeting you in Rome!

more info
Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists and Engineers specialising in:

  • CMC
  • Compliance
  • Design Controls
  • Device Development & Manufacturing
  • Drug Delivery & Devices
  • Human Factors
  • Packaging
  • Pre-filled Syringes
  • Quality Assurance / Control
  • Research & Development
  • Usability Engineering
  • Combination Products
  • Controls & Robotics
  • Device Design
  • Device Engineering & Design
  • Formulation Sciences
  • Inhalation Products
  • Parenteral Products
  • Product Quality
  • Regulatory Affairs
  • Risk Management
  • Validation
Key Practical Learning Points of the Summit

Overview of the EU MDR and status of its implementation, role of notified bodies
EU MDR Article 117: impact to drug delivery devices
Digitalisation of combination products
Digital health: challenges and opportunities for labelling
Connected devices and wearables
Technical challenges and correct specification
Leveraging the new technologies for opportunities in the development of new therapies and meeting patient needs
Design control and quality systems
Combination products lifecycle management
Combination product postmarketing safety reporting
Impact on manufacturers
Successful launch of your combination product
Speakers
Mike Wallenstein, CH

Executive Director QA/Senior Compliance Officer/ Head Novartis DCP Expert Network

Novartis International AG

Didier Pertuy, FR

VP, Global Head of Drug/Device Integrated Development & Device Strategy

Sanofi

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

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