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Drug-Device Combination Products Live Event

  • 30th September 2020
  • Zoom flag Zoom
  • ONLINE

DDC Live Event provides the appropriate platform for industry leaders to discuss drug-device combination product development's best practices.

Our speakers will shed light on EU MDR guidelines and regulations, preparing your documentation for MDR Article 117, the opinion of Notified Bodies, and proactive risk management.

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About Drug-Device Combination Products Event 

Drug-Device Combination Products Live Event will share insights on the Article 117 (MDR) and Its Impact on Combination Products and tips for preparing documentation for MDR Article 117 Notified Body Opinion Review.

To find out more information about the Drug-Device Combination Products Online Event request the brochure. After the event, you will receive a digital certificate of attendance.

Who should attend

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

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

Industry

  • Pharmaceutical
  • Biotechnology
  • Medical Devices
  • Notified Bodies
  • Law Practice
  • Academia

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • Overview of the EU MDR and status of its implementation
  • Role of notified bodies
  • EU MDR Article 117: impact on drug delivery devices
  • How to prepare your documentation for MDR Article 117?
  • Risk Management     

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

Mike Wallenstein has over 25 years of experience in QA, R&D, and manufactur­ing within the medical device & pharmaceutical industry with positions as head of quality systems, global head of auditing, and compliance. His is currently director of QA & global head of device & combination product expert network at Novartis International, based in Basel, Switzerland.

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

Ph.D. in Strategy and Organizations, Juan has specialized in regulatory compliance projects for devices and combination products, particularly focusing on the new Medical Device Regulation. Juan both leads and acts as subject matter expert in the MDR-remediation for pharmaceutical clients and the submissions for Notified Body Opinions for drug-device combinations. 

Stephanie Göbel, DE

Product Specialist Art.117

TÜV SÜD Product Service GmbH

At TÜV SÜD Product Service GmbH, Stephanie Göbel is Product Specialist for Art. 117. She is re-joining TÜV SÜD Product Service GmbH – from April 2015 to December 2016 she already worked as auditor within the depart­ment of active medical devices. Apart from her role as auditor, Stephanie has gained experience in various positions within the medical device and pharmaceutical industry for more than 10 years: as development engineer in the field of bioresorbable implants and as quality manager in the field of in-vitro diagnostic devices and drug-device combination products. Regard­ing educational background, Stephanie studied medical engineering at the Technical University Munich (Germany), at the University of Applied Sciences Ulm (Germany) and the University of Bradford (UK); She holds a diploma engineering degree in medical engineering.

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Mark A. Chipperfield spent 20 years working within large pharma (GSK, Sanofi Aventis, Novartis, Roche) in the field of drug delivery devices and special purpose packaging. Throughout his career, he has been heavily involved in the development of combination products in several forms: solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen-injectors, auto-injectors, dispensers and special purpose applicators. Since 2015, he has been an independent consultant supporting pharma companies, suppliers and device innovators across the globe to develop, launch, and maintain their products.

Susan Neadle, US

Sr. Director, Global Value Chain Quality Design

Johnson & Johnson

Susan Neadle joined Johnson & Johnson in 1995. Her distinguished career there includes integral leadership roles in R&D and Quality Engineering, spanning pharmaceuticals, medical devices, and consumer products sectors as well as J&J Enterprise. In her current role, Sr. Director, Global Value Chain Quality Design, she serves as Chair of J&J's Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also leads J&J's cross-sector Combination Products Community of Practice. 

Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet the Combination Products' health authority regulations into J&J's Pharmaceutical sector (Janssen). She has applied her Design Excellence Blackbelt skills to drive and develop significant new products and business impacts. Her leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, J&J's highest honor for innovation excellence. Susan holds numerous patents and publications and frequently speaks in public venues. She is actively engaged in several industry working groups on a range of Combination Products topics, including ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, PDA and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice and Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering and a B.S. in biology/chemistry, as well as a Fellowship in the American Academy of Optometry. Prior to J&J, Susan held roles in materials analysis, product development, and commercialization at IBM, Unilever, and Organon Teknika.

Roman Mathaes, CH

Principal Scientist Senior Group Leader

Lonza

Roman Mathaes is a group leader within the Lonza Drug Product Service organisa­tion. He is leading the Lonza particle lab and the container closure integrity testing. In this role, Roman is responsible for particle analytics in drug products and container closure integrity testing of vials and pre-filled syringes and process development of capping/crimping. Prior to this assignment, Roman was working within Roche/Ge­nentech network supporting process development of the commercial manufacturing. Roman is an active member of the European CCI industry focus group and part of the BPOG CCI workstream. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in pharmaceutical technology from the University of Munich for his work on subvisible particle characterisation.

Mike Wallenstein, CH

Global Head MDR Implementation & DD&C Compliance

Novartis International AG

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

Stephanie Göbel, DE

Product Specialist Art.117

TÜV SÜD Product Service GmbH

Mark A. Chipperfield, UK

Company Director & Principal Consultant

Corvus Device Consultancy

Susan Neadle, US

Sr. Director, Global Value Chain Quality Design

Johnson & Johnson

Roman Mathaes, CH

Principal Scientist Senior Group Leader

Lonza

What our
participants
are saying

The webinar was very informative, and all the speakers had valuable information to share regarding the delay of the EU MDR and COVID-19 impact.

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Well organised and thoroughly enjoyed. All presentations were excellent.

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I absolutely enjoyed the meeting with such a focused topic.

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