Drug/Device Combination Products Summit 2018 - Kongress / Konferenz von Qepler s.r.o.

Get up to date with the regulatory and quality compliance strategies for combination product development.



Drug-device combination products represent the next wave of drug delivery devices of increasing complexity. The development of a process for the development of pharmaceuticals and devices, the definition of the elements of design control, the determination of quality systems and manufacturing processes. It is critical to establish a regulatory and clinical strategy from early on to development. Drug-based device combinations, as well as the total product life cycle.

The featured talks on:

  • Integration of drug and device: combination product mindset
  • How to prioritize different regulations in product development
  • Risk-based approaches to the design and development of drug delivery systems
  • Guidelines in design control for combination products
  • Turning user needs into design inputs
  • Human factors validation vs. design validation
  • Design verification strategies
  • Key quality systems expectations during design
  • Biocompatibility evaluation of combination products
  • Stability and shelf-life successful practices
  • Clinical and safety parameters for combination products
  • Technology transfer during lifecycle of combination products
  • Documentation requirements for combination products
  • Best practices for post-approval changes
  • Considerations on legacy products
  • Digitization to support product development


VENUE:  The event venue is NH Collection Berlin Mitte at Checkpoint Charlie , Leipziger Str. 106-111. We have a special rate for registered participants - 109 EUR / night including breakfast.



Day 1st | Tuesday, 4 December 2018

08:30 -  Registration and Welcome Coffee 09:00 -  Opening Address from the Chairman


09:10 -  Case Study # 1 (To Be Announced)

Serge Mathonet Global Regulatory Affairs CMC Biologics - Site Leader - Sanofi R & D, France

09:50 -  Speed ​​Networking

10:30 -  Case Study # 2 (To Be Announced)

Bjorg K. Hunter Device Engineering Manager, GSK, United Kingdom

11:10 -  Morning coffee and networking break

11:40 -  Case Study # 3 ( To Be Announced)

Vikas Jaitely Senior Manager, Merck Group Switzerland

12:20 -  Using the delivery system concept to comply with MDR and article 117 requirements.

  • Delivery system concept in pharma and managing future complexity
  • Delivery system platforms and set up
  • Strategies for streamlining Approval of drug / device combinations in EU with respect to introduction of MDR and article 117

Dr. Daniel Latham Head - Device Development & LCM, Device Development & Commercialization , Novartis, Switzerland

13:00 -  Business lunch

14:00 -  TREND REPORTING under MDR - Change and Impact.

  • Highlights and reinforcements of the MDR on Trend reporting requirement
  • Main changes compared to MEDDEV 2.12 / 1 rev.8
  • Use Quality Management System elements to meet trend reporting requirement
  • Practical approach for implementation

Learning outcome: The participants are expected to have a good understanding of the MDR, and to return home with a suitable approach and strategy for implementation.

Fayez Abou Hamad MD Vigilance Expert - Pharmacist, Complaint & Vigilance Manager , TERUMO EUROPE, Owner and founder , MDV-Solve Medical Device Consulting , Belgium


14:40 -  Life Cycle Management: Exenatide case study.

  • Bydureon Bcise. Life cycle management journey
  • Four generations of device design used to administer exenatide in the last decade
  • Analyzing the key drivers for the device
  • Regulatory pathways
  • Clinical data and studies
  • Changes in patient / market acceptance / Human Factors
  • Outside world, competitor products

Michael Noderer Associate Principal Scientist , AstraZeneca , United Kingdom

15:20 -  Afternoon coffee and networking break

15:50 -  Considerations for different types of drug / device combination products.

  • Some of the different ways of combining drugs and devices
  • Designation, classification and regulatory pathways
  • What applies where?
  • Some technical considerations
  • Clinical aspects to consider

Mark A. Chipperfield Company Director and Principal Consultant , Corvus Device , United Kingdom

16:30 -  Lifecycle Management of Combination Products

Combination products, as the term implies, draws from the pharmaceutical and medical device industries, and force and regulators into a complex and challenging evaluation of opportunities and risks. From a commercial perspective, to a competitor's move, to increase the value of the product by offering additional value to the patient, or simply bring it up to the standard of care. Whatever the change to the product, a series of regulatory, commercial, or supply chain consequences have been considered to make the effort successful. The LCM strategy for biologics and biosimilars.

Dr. Dirk Kreder Founder and CEO , anteris medical GmbH , Germany

17:10Chairman's closing remarks and end of day one 18:30Business dinner

Day 2nd | Wednesday, 5 December 2018

08:30 -  Registration and Welcome Coffee 09:00 -  Opening Address from the Chairman


09:10 -  Combination Products - regional similarities and differences in GMP

  • Combination Product (or Drug Product) by definition (US / EU / CA / JP / Brazil / Australia / India)
  • GMP requirements in the countries listed above; with focus on single integral products, intended exclusively for use in the given combination, not reusable (PMOA DP)

Dr. Silke Conrad Quality Expert Medical Device , Novartis , Switzerland

09:50 -  Risk Management for Combination Medical Devices

  • Understanding risk and management or risk for medical devices
  • Requirements of ISO 14971
  • Unique risks for combination medical devices
  • Tools of risk management

10:30 -  Morning coffee and networking break


11:00 - Integration of drug and device: combination product mindset.

  • Recent changes in inhalation product development regulatory environment in letter, US & EU
  • When is ISO 13485 QS or 21 CFR 820 required for inhalation product development (in addition to GMP)
  • Stage-gate development process for inhalation devices
  • Combining new inhalation device & a new drug formulation in development - dilemmas of simultaneous development
  • Key inhalation device development aspects

Jussi Haikarainen Head of Inhalation Technology, Easyhal Therapy Area, R & D, Orion Corporation - Orion Pharma , Finland

11:40 -  Design Control, Human Factors and Risk Management. An integrated approach.

  • Combination product definitions and development process overview
  • Intended use as central key for the entire development
  • How Design Control, Risk Management and Human Factors interact with each other in the process
  • Design Validation and PMS

Davide Mercadante Sr. Associate, Product Development Quality (PDQ) - Device Development Quality (DDQ), Biogen , Switzerland

12:20 -  Entering a new market - aspects of ensuring patient centricity.

  • Getting familiar with the target users
  • Making a short and longer term usability strategy to support device development
  • Shaping usability to fit the organization
  • The interface between human factor studies and clinical trials
  • Involving key stakeholders in the secure process anchoring of study insights
  • Systemizing user involvement with tools and templates

Fell Falck Larsen Senior Usability Engineer , LEO Pharma , Denmark

13:00 -  Business lunch

14:00 -  Life Cycle Management of the Soft Mist Inhaler Respimat®

  • Profile of a perfect inhaler
  • Challenges of combination products
  • Respimat - Design and main subassemblies
  • Device performance and user requirements
  • Carbon footprint

Dr. Raphael Krampe Scientist , Boehringer Ingelheim microParts , Germany


14:40 -  Drug-device compatibility: Where is the guideline?

  • Interaction of drugs with materials.
  • In-use stability testing, how do you test this?
  • Can this replace Extractables & Leachables testing?
  • Case studies.

Dr. Ir. Lise Vanderkelen Department of Pharmaceutical and Microbiology , Nelson Labs Europe, Belgium

15:20 -  Panel Discussion

15:50 -  Chairman's closing remarks and end of summit



  • TPC Projects Development Expert -  Pharmathen SA, Greece
  • Senior Researcher, Packaging & Device -  Astellas Pharma Inc., Japan
  • Manager Strategy and Marketing -  H & T Presspart, United Kingdom
  • Sr. Manager Product Quality -  Janssen, Belgium
  • Global Marketing Director - Medical OEM -  Pall Life Sciences, United Kingdom
  • Director, Business Development -  Cytel, Germany
  • Project Manager -  Progress-PME, Netherlands
  • Operational Manager -  Progress-PME , Netherlands
  • Study Director Pharma Services -  Nelson Labs, Belgium
  • Managing Director -  Maetrics Limited, United Kingdom
  • Director Corporate Quality Management -  tesa Labtec GmbH , Germany
  • Hub Domain Leader Quality / Operations -  Sanofi-Aventis , Germany
  • Head of Device Manufacturing Technology Hub -  Sanofi-Aventis , Germany
  • Consultant - Freelancer, Germany
  • Medicinal Technical Expert -  BSI Group, United Kingdom
  • Global Quality Advisor Medical Devices & Combination Products -  Eli Lilly, France
  • Regulatory Affairs Manager -  Spiegelberg GmbH & Co. KG, Germany
  • Global Regulatory Affairs CMC Biologics - Site Leader -  Sanofi R & D,  France
  • Device Engineering Manager  -  GSK,  United Kingdom
  • Senior Manager Merck Group ,  Switzerland
  • Head - Device Development & LCM, Device Development & Commercialization -  Novartis , Switzerland
  • MD Vigilance Expert - Pharmacist, Complaint & Vigilance Manager -  TERUMO EUROPE, Belgium
  • Associate Principal Scientist -  AstraZeneca, United Kingdom
  • Company Director and Principal Consultant -  Corvus Device, United Kingdom
  • Founder and CEO -  anteris medical GmbH, Germany
  • Quality Expert Medical Device -  Novartis, Switzerland
  • Head of Inhalation Technology, Easyhal Therapy Area, R & D Orion Corporation - Orion Pharma, Finland
  • Sr. Associate, Product Development Quality (PDQ) - Device Development Quality (DDQ) -  Biogen , Switzerland
  • Senior Usability Engineer -  LEO Pharma , Denmark
  • Scientist -  Boehringer Ingelheim microParts , Germany
  • Department of Pharmaceutical and Microbiology -  Nelson Labs Europe , Belgium



  • How to get streamline drug / device combination approval in accordance with MDR and article 117 requirements?
  • How to meet trend reporting requirement under MDR?
  • What is the best LCM strategy for your combination product?
  • How to integrate the dilemma of simultaneous development?
  • Where is the guideline for drug / device compatibility?



  • Combination Products
  • Device development
  • Device Engineering
  • Device Manufacturing
  • Medical Devices
  • Device Design
  • Design Controls
  • Design Verification
  • Design Validation
  • Human Factors
  • Usability Engineering
  • Risk Management
  • Drug Delivery
  • Pharmaceutical Formulation
  • CMC
  • Packaging
  • Materials Development
  • Research & Development
  • QA / QC
  • Regulatory Affairs
  • Business development



  • Device Design and Development
  • Drug Delivery Systems
  • Primary Packaging
  • Contract Manufacturing
  • Analytical Services
  • Injection molding
  • Sterilization Technologies
  • Digital Health Solutions

SG-Seminar-Nr.: 5208098

Anbieter-Seminar-Nr.: ddcp18

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