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6th Drug-Device Combination Products Conference

  • 15th – 16th October 2024
  • Germany flag Germany Berlin & Online

As drug–device combination products continue demonstrate growth at a rapid pace, the experts in drug delivery alongside device development engineers at the #VLDDCP summit will offer diverse perspectives on ensuring the compatibility and operational efficiency of drug products and delivery devices, exploring recent experience in the digital health, connected combination products and wearable injectors.

The 6th Drug-Device Combination Products Conference in Berlin aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms, particularly during the challenging initial phases of development when finalising formulations and dosage while navigating regulatory complexities presents significant hurdles to the successful advancement of sustainable and connected combined drug-device products.

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About the 6th Drug-Device Combination Products (#VLDDCP by Vonlanthen)

As drug–device combination products continue demonstrate growth at a rapid pace, the experts in drug delivery alongside device development engineers at the #VLDDCP summit will offer diverse perspectives on ensuring the compatibility and operational efficiency of drug products and delivery devices, exploring recent experience in the digital health, connected combination products and wearable injectors.

The combination products professionals will focus on:

  • Harmonising design controls with quality by design principles
  • Determining device specifications during early development stages
  • Assessing material compatibility and safety
  • Navigating regulatory pathways and quality management systems
  • Defining essential performance criteria
  • Conducting design verification and validation
  • Managing risk factors
  • Ensuring device compliance and meeting essential performance standards
  • Facilitating compatibility and clinical assessments
  • Exploring sustainable and connected combination products and wearable injectors

The 6th Drug-Device Combination Products Conference in Berlin aims to address the critical importance of ensuring harmony between drug products and their delivery mechanisms, particularly during the challenging initial phases of development when finalising formulations and dosage while navigating regulatory complexities presents significant hurdles to the successful advancement of sustainable and connected combined drug-device products.

 

Who Should Attend  

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

  • Assembling
  • Automation
  • Chemistry, Manufacturing and Controls (CMC)
  • Clean Room
  • Combination Products
  • Compatibility
  • Connected Devices
  • Connected Health
  • Connectivity
  • Design & Engineering
  • Design Architect
  • Device Development
  • Digital Health
  • Drug Delivery Systems (DDSs)
  • Drug Development
  • Drug Packaging
  • eHealth
  • Emulsions
  • Extractables and Leachables (E&L)
  • Filling Process
  • Filtration Process
  • Formulation
  • Glass
  • Good Manufacturing Practice (GMP)
  • Human Factors
  • Human Factors Engineering (HFE)
  • Industrial Design
  • Injectable Drugs
  • Injectables
  • Injection Devices
  • Integrity Testing
  • Lyophilisation
  • Manufacturing
  • Material Science
  • Medical Devices
  • Needles
  • Packaging
  • Packaging Material
  • Parenteral Drugs
  • Parenterals
  • Pharmaceutical Products
  • Pharmaceutical Injectors
  • Plastic
  • Pre-Filled Syringes (PFS
  • Process Development
  • Processing
  • Quality Assurance (QA)l
  • Quality Control (QC)
  • Raw Materials
  • Regulatory
  • Regulatory Affairs
  • Research & Development
  • Risk Management
  • Robotics
  • Safety
  • Safety, Identity, Strength, Purity, Quality (SISPQ)
  • Smart Devices
  • Sterile Drugs
  • Sterile Production
  • Sterile Products
  • Suspensions
  • Sustainability
  • Syringe
  • Syringes
  • User Experience (UX)
  • Vaccine Product
  • Vaccines
  • Validation
  • Wearable Injectors

Register by June 30th

The Early Bird Offer expires in 36 days!

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

  • Successful development of drug-device combination products requires interdisciplinary collaboration between drug delivery experts and device development engineers.
  • Harmonising design controls with quality by design principles ensures the compatibility and operational efficiency of drug products and delivery devices.
  • Early determination of device specifications streamlines development and addresses regulatory challenges.
  • Thorough assessment of material compatibility and safety is essential for product reliability and safety.
  • Understanding and navigating regulatory pathways is critical for achieving compliance and market approval.
  • Leveraging new EU Medical Device Regulations (MDRs) and future perspectives for successful combination products regulatory submissions.
  • Defining essential performance criteria establishes benchmarks for product effectiveness and reliability.
  • Conducting rigorous design verification and validation processes confirms device functionality and safety.
  • Effective risk management strategies mitigate potential hazards associated with combination products.
  • Achieving cost efficiency and reducing environmental impact are essential considerations in product development.
  • Exploring technology-based sustainability approaches can lead to innovative solutions for environmental sustainability.
  • Harnessing innovative technologies, strategies, and methodologies will advance development of sustainable and connected combination products and wearable injectors.

Register by June 30th

The Early Bird Offer expires in 36 days!

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

Bjarne Sørensen is a director of front-end innovation at Phillips-Medisize, based in the company’s development centre in Denmark. With more than 35 years of experience within product, strategy, and business development, Bjarne has a very visible track record within different business areas. At Phillips-Medisize, he participates in customer projects, typically involving electronic injectors and connected health systems. He is also deeply involved in new electronic platform programs, especially on conceptual, technical, and sustainability aspects.

Dr. René Dathe, DE

Head Quality Digital Therapeutics and Connected Health

Novartis

Dr. René Dathe, MBA is currently Head Quality Digital Therapeutics and Connected Heath at Novartis. He is accountable for E2E Quality DTx and CH portfolio (Development projects and Commercial products) and Connected Health Ecosystem QMS.

He was Head Quality Medical Device Sandoz Development and LCM at Novartis Global Drug Development for last 3 years. Prior to his engagement, he worked as Project Manager for global alliances (Cardiovascular & Metabolic, Immunology & Inflammation) and Scientist (Diabetes R&D) at Sanofi.

René Dathe obtained his Diploma (M.Sc.) in chemistry at TU Chemnitz, followed by an MBA in Frankfurt. He was awarded a doctorate in business administration by the University of Gloucestershire, UK for his research work on medical device innovations.

Anne-Sofie Madsen Staples, DK

Innovation Lead, Advanced Innovation Engineer

Novo Nordisk

Dr. William Denny, AT

Senior Project Leader - Drug/Device Combination Products

Sandoz Device Development Centre

Bernard Gauthier, FR

Global Product Owner – GenMed Digital HealthCare

Sanofi

Paul Johnson, UK

Managing Director

Paul Johnson Consulting Limited

Paul Johnson is an independent consultant to the pharmaceutical industry who has specialised in the CMC aspects of NCE and generic inhaled product development since 2018 serving clients in large/small pharma companies, pharmaceutical component suppliers, and pharmaceutical service providers.

Paul gained 20 years of experience leading teams and projects involved for the development of inhaled products at Glaxo Smith Kline in a range of delivery systems, including dry powder inhalers, pressurised metered dose inhalers, and nebulisers. He is most proud to have led the CMC teams from early development, through clinical stages, registration, launch and lifecycle management for Relvar/Breo Ellipta, and provided leadership for the CMC aspects for the entire GSK inhaled franchise.  

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Yvonne leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Yvonne holds a BSc in industrial design and an MSc in human technology interaction, both from Eindhoven University of Technology (NL).

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads Global Pharma clients in complex compliance projects to meet the latest regulatory requirements. In his role as Managing Director at Beyond Conception, Juan has pioneered efforts in Combination Products in Europe by leading clients to obtain Notified Body Opinions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest value to his clients.

Dr. Horacio M. Pace-Bedetti, DK

Principal Usability Researcher

Novo Nordisk

Patrice Becker, FR

Global Director Scientific Communications, Surgical Innovations Medical Affairs

St Gilesmedical London & Berlin

Patrice Becker is a medical device industry expert with more than 30 years of experience in clinical and medical affairs. He holds a masters degree in pharmacology and a masters degree in business administration for pharmaceutical and biomedical companies. After several years of experience in small medical devices companies, he joined Biomatech a consulting and testing company focused on medical devices testing  as a clinical research manager . Then he joined  Sofradim/Medtronic in 1998, building and taking the lead of the clinical research department for 13 years. then he was the leader of the scientific communication department for abdominal and robotic surgery until february 2023.  He is now leading activities for St Gilesmedical in France. St Gilesmedical is a scientific communication and medical writing independent company based in London and Berlin.

Shai Assia, IL

Head of Medical Device Development

Clexio Biosciences

Shai Assia is Head of Medical Device Development at Clexio Biosciences. He is a Product Development leader with more than 15 years of experience in a wide range of responsibilities and organizations. Shai leads the Medical Device Design, Development and Manufacturing for novel Combination Products and Drug-Delivery Platforms. Shai holds a BSc in Bio-Medical Engineering from Tel Aviv University as well as a MSc in Mechanical Engineering and MBA from the Massachusetts Institute of Technology (MIT), where he received the Leaders for Global Operations Fellowship.

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

Dr. René Dathe, DE

Head Quality Digital Therapeutics and Connected Health

Novartis

Anne-Sofie Madsen Staples, DK

Innovation Lead, Advanced Innovation Engineer

Novo Nordisk

Dr. William Denny, AT

Senior Project Leader - Drug/Device Combination Products

Sandoz Device Development Centre

Bernard Gauthier, FR

Global Product Owner – GenMed Digital HealthCare

Sanofi

Paul Johnson, UK

Managing Director

Paul Johnson Consulting Limited

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

Dr. Horacio M. Pace-Bedetti, DK

Principal Usability Researcher

Novo Nordisk

Patrice Becker, FR

Global Director Scientific Communications, Surgical Innovations Medical Affairs

St Gilesmedical London & Berlin

Shai Assia, IL

Head of Medical Device Development

Clexio Biosciences

BROCHURE 

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What our
participants
are saying

I want to express my gratitude to Vonlanthen for hosting such a fantastic event and for giving me the opportunity to hear from esteemed speakers like Susan Neadle, Mark A. Chipperfield, Mike Wallenstein, and Roman Mathaes. It was truly an honor to be able to participate in this live event and I appreciated the opportunity to learn from such knowledgeable individuals. Thank you for putting together such a great conference! 

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Attendee

Attending the Drug-Device Combinational Products Conference by Vonlanthen was an exceptional and enlightening experience. The caliber of speakers was truly outstanding and the diversity in geography was incredibly valuable to me as I work between the USA and Europe. The conference provided me with an abundance of cutting-edge information on the latest advancements and challenges in the field of drug-device combinations and sustainability of products. The networking opportunities were also fantastic, allowing me to connect and collaborate with a diverse group of professionals in my field. I am already eagerly anticipating the next meeting and I extend my gratitude to the dedicated organizers for putting together such a successful and informative event.

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Attendee

I recently attended the Drug-Device Combinational Products Conference by Vonlanthen and it was an incredibly informative and valuable experience. The speakers were top-notch experts in their fields and provided valuable insights on the latest developments in the industry. The networking opportunities were also great, allowing me to connect with other professionals in my field. I highly recommend this conference to anyone in the pharmaceutical industry looking to stay informed and stay ahead of the curve. 

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Attendee