Course information

  • 1 day

  •  

    23 November

Investment

The investment is €795,- per participant (ex. VAT).

Included are the course material, beverages and lunch.

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HI-MT9: Development of combination products - from idea to approval

Developing a combination product that includes both a medicinal product and a medical device means navigating the requirements of both the medicines legislation and the MDR. This training provides clarity on how these requirements interact, helping you make the right decisions early and set up your development process in a structured, compliant way.

Combination products that include both a medicinal product and a medical device sit at the intersection of the regulatory frameworks for each product. Understanding how these regulatory frameworks interact is essential for defining a realistic development strategy and avoiding delays later in the process.

During this one‑day training, you will gain clear insight into the applicable regulations, the possible approval pathways and the key documentation requirements for combination products. The focus is on practical interpretation and application, enabling you to translate regulatory expectations directly into concrete next steps for your product.

 

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What you'll learn

After this training, you will be able to:

  • Explain the regulatory context for drug–device combination products

  • Determine which regulatory framework applies to your product

  • Understand how CE marking and marketing authorization relate

  • Set up a structured development approach that aligns with regulatory expectations

  • Identify the key documentation needed to support market approval

 

Teaching professionals.

Lisanne Karbaat

Lisanne Karbaat

Regulatory Affairs Expert IVDR
Lisanne is an enthusiastic and thorough manager with extensive knowledge about regulatory requirements. She holds a masters degree in Biomedical Engineering and has several years of academic research experience using various in vitro diagnostic technologies. Her goal in medical projects is to let the build-up of documentation support the development of a device, so that people can bring safe and good products faster to the market.
Wendy Verschuren

Wendy Verschuren

Head of Regulatory Affairs at Interdos
With 23 years of pharmaceutical industry experience, Wendy Verschuren brings deep expertise in development, quality and regulatory requirements for medicinal products, with a growing focus on combination products. As Head of Regulatory Affairs, she leads a diverse team of nine professionals, fostering scientific depth, collaboration and pragmatic decision-making. Wendy translates complex regulatory requirements into clear, practical guidance, helping organizations make well-founded decisions and run development projects in a structured, compliant way.
Development of combination products

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What you'll learn

Course Content

During the training, we cover:

  • Market approval fundamentals
    Why market approval is required and how approval routes differ for medical devices and medicinal products.

  • Regulatory classification of combination products
    How to determine whether your product is regulated as a medical device or a medicinal product, supported by practical examples.

  • Developing combination products
    Integrating best practices from both device and drug development into one coherent development approach.

  • Technical documentation requirements
    Overview of documentation expectations and how to approach them in practice.

Exercises and examples are used throughout the day to help you apply the content to real-life situations.

 

Practical information.

For whom

Target audience

This training is intended for professionals involved in the development and production of drug–device combination products, such as:

  • Development and engineering professionals

  • Product managers

  • Quality and regulatory professionals

Prerequisites

This course is suitable for professionals with at least a bachelor’s degree or equivalent working experience.
Prior knowledge of MDR, IVDR, GMP, or EU medicinal product registration is not required.

Certificate
After completing the course, participants receive proof of participation. 

Location & Dates

Location

Enschede – The Gallery, Hengelosestraat 500

Dates 2026

23 November

Group size 

Maximum number of participants: 10.