Trainings By Informa Markets

Regulatory and Quality Management for Drug-Device Combination Products

04 Oct - 05 Oct 2023

Workshop Overview

The combination of drugs and devices is rapidly increasing. In some situations, it is difficult to determine as to which regulations, submission procedure and pathway to market must be followed. Correct classification is key as in the European Union (EU), combination products are regulated as either medicinal products or medical devices. Despite their advantages, combination products present new techno[1]logical and organisational challenges. They require new product development strategies compared to standalone products, drugs, and devices.

This course will cover the definition of combination products in EU, regulatory pathways, submission documents, impact of EU MDR 2017/745 (EU MDR), notified body selection and interaction and will explain the current requirements.

Program Focus

• Regulatory & legislative requirements for Drug Device Combination Products

• Borderline classification in EU: Medical Device or Medicinal product?

• EU market access for medicines with a device component

• Key considerations for Combinations regulated as a medicinal product

• EU market access for Combinations regulated as a medical device

• EU MDR key changes and its impact on Drug Device Combination Products

• Labelling requirements for drug device combination products

• Life cycle management

• Post-market surveillance for combina tion products

• Quality system requirements

Benefits of Attending

Medtech and Pharmaceutical/biotech companies must stay informed about implications of the EU MDR. The EU MDR introduces major changes in Europe for single integral combination products. For marketed CE marked devices under MDD and AIMDD whether standalone or co-packaged with medicinal products, these devices must also conform to EU MDR.

Substantial device changes of already marketed single integral combination products could require Notified Body opinion. To ensure that operations conform with the EU MDR, pharmaceutical/biotech companies must have compliant design controls, integrated risk-management procedures, and improved processes for complaint handling. Companies must have closer oversight of their device and component manufacturers.

Given overdemand for notified bodies, it is important to get the documentation right first time.

Who Should Attend?

  • Quality Assurance/Quality Control
  • Regulatory Affairs
  • Design and development team
  • Individuals currently working with medicinal products using a delivery device
  • Device component suppliers to the pharmaceutical industry
  • Individuals responsible for post market surveillance activities

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