Joint Workshop of AKRA TEAM GmbH &
Dr. Ebeling & Assoc. GmbH

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Drug-Device-Combinations (DDCs) represent a heterogenous group of products, which are a combination of medical devices on one hand and pharmaceutical products on the other. This product group has evolved significantly over the past years as it bears a high potential of clinical benefits for treatment of various types of diseases.

The product spectrum ranges from simple prefilled syringes (filled with a drug component), auto injection devices to complex delivery on demand devices which are implanted (e.g. insulin pumps). Other devices represent a combination of a traditional medical device (e.g. a stent) coated with a pharmaceutical to improve the clinical outcome of the treatment (e.g. drug eluting stent). Depending on the principal mode of action, either the medical device regulation (Regulation 2017/745) or medicinal products directive (Directive 2001/83/EC) is the primary applicable legislation.

This has significant impact on the legislative processes to be applied. In addition, article 117 of the EU MDR specifically bears new obligations for pharmaceutical manufacturers.

This one-day workshop provided by specialists of AKRA TEAM GmbH and Dr. Ebeling & Assoc. GmbH will provide a structured step-by-step approach, how the different legislations are to be considered and applied for different types of DDCs.

Overview of covered topics

• Definition / Wording / Nomenclature
• Types and variants of Devices, combining MDs & MPs
• Decision making process & stakeholders involved
• Overview & characteristics of different Drug-Device-Combination products
• Sources of information
• Processes involved

Purpose of the training

The participants shall be enabled to:

• To gain an overview about various types of Drug-Device-Combination Products
• Understand the applicable legislation and stakeholders involved
• To gain an overview about the processes
• Understand the differences between the various product types regarding legislation

Who should attend

• Pharma-Manufacturers
• Clinical Affairs Manager
• Regulatory Affairs Manager
• Clinical Affairs Experts
• Subject Matter Experts

Basic knowledge required

• Basic knowledge in EU-MDR
• Basics in Medicinal Products

Presenting experts

Our trainers have long-time experience working with one of the biggest notified bodies and in clinical research and regulatory consulting as well as pharma.