Development of Combination Products: Critical Interactions

Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development of these products raises a number of complex issues regarding the development process and their manufacture. The quality and regulatory aspects to consider are also challenging. This seminar will clarify the EU and US approach to drug/device and device/drug combination products. It will discuss the requirements for the Device Technical File/Design File and will explain the Biological and Synthetic Drug Regulation and the registration procedure for these products.

The programme will also cover the regulatory strategy to adopt for these products and the key aspects of GMP and quality processes applicable for drug/device and device/drug products, including the data expectations for the Common Technical Document.
Delegates will find this a comprehensive overview of the requirements for these drug/device and device/drug combination products and will have an opportunity to discuss the complexities with an expert in this field.

Benefits of attending:

• Clarify the definitions for drug/device and device/drug combination products in the EU and USA
• Consider the requirements for the Device Technical File/Design File
• Comply with the Biological and Synthetic Drug Regulation and its requirements
• Understand the registration procedures for devices and medicines in the EU and USA
• Determine the data required for the Common Technical Document
• Consider the regulatory strategy depending on your product
  n Gain practical advice on how to apply the ISO standards

• All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug products)
• Pharmacovigilance/vigilance personnel
• Device experts looking to expand their knowledge to medicines and vice-versa

Defining a drug/device and device/drug product

• EU approach
• US approach

Understanding devices

• Medical Device Regulation – EU
• CE marking and Notified Body interactions
• CDRH definitions – US – 510K and PMA
• Labelling
• Vigilance requirements

Regulatory procedures for drug/device and device/drug products

• EU procedures
• US and Office of Combination Products

Device Technical File/ Design File

• What is required
• Structure
• Bench testing
• Potential clinical requirements

Workshop: Technical File/ Design File

Understanding the biological and synthetic drug regulation

• EU/US definition of medicinal product
• Labelling
• Pharmacovigilance
• Quality requirements

Registration procedures

• Devices EU/US
• Medicines EU/US

GMP and ISO standards

• Practical application
• Interpretation of the standards

Common Technical Document (CTD)

• Where to put data
• Data expectations
• Applying QbD (Quality by Design)

Workshop: CTD requirements – tracking critical documents

Key considerations for the regulatory strategy

• Deciding which regulatory route to take
• Device and product registrations
• Combination only registrations
• Desired labelling

Workshop: regulatory strategy