3rd Annual Drug/Device Combination Products Summit
10-11

April 2019

Amsterdam

Netherlands

About

We would like to welcome you to the 3rd Annual Drug/Device Combination Products Summit on April 10th-11th, 2019, in Amsterdam. Combination products are still relatively new delivery sys¬tems for the healthcare market. New approaches are crucial for precise administration without inducing any harm. New laws and regulations have led to the increase in technological requirements within this industry. This event provides the appropriate platform for industry leaders to discuss the best practices in drug/device combination products development. T...

We would like to welcome you to the 3rd Annual Drug/Device Combination Products Summit on April 10th-11th, 2019, in Amsterdam. Combination products are still relatively new delivery sys¬tems for the healthcare market. New approaches are crucial for precise administration without inducing any harm. New laws and regulations have led to the increase in technological requirements within this industry. 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, registration requirements, market trends and device needs, technologies and innovations, and delivery aspects. We are looking forward to your participation in this engaging Summit in Amsterdam this coming April!

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
Updates on guidelines, regulations and registration requirements
Technical challenges and correct specifications
Managing innovation and complexity in pharma
Achieving a smooth market access
Strategic requirements for best-in-class drug/device combination products
Risk assessment for faster product realisation
Design verification, usability and process validation
Quality management systems
Impact on manufacturers
Speakers
Philipp Richard, CH

Product & Account Manager/ Delivery Systems

Ypsomed AG

Bjorg K. Hunter, UK

Device Engineering Manager

GSK

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

Davide Mercadante, CH

Senior Associate II, Supplier Quality

Biogen

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Dr. Daniel Latham, CH

Head of Device Development Operations, Device Development & Commercialisation – BTDM

Novartis Pharma AG

Dr. Herbert Wachtel, DE

Senior Principal Scientist / Analytical Development

Boehringer Ingelheim Pharma GmbH & Co. KG

Dr. Herbert Wachtel, DE

Senior Principal Scientist / Analytical Development

Boehringer Ingelheim Pharma GmbH & Co. KG

Gregor Anderson, UK

Managing Director

Pharmacentric Solutions Ltd

Dr. Bassil Akra, DE

Vice President – Global Focus Teams / Active Implantable, Cardiovascular, Orthopaedic, Aesthetic Devices & Clinical

TÜV SÜD Product Service GmbH

Margaret Kelly, CH

Device Manager Processes & DHF / Device Development & Commercialisation

Novartis

Torsten Kneuss, DE

QA Manager, Combination Products

Bayer AG

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