DUBLIN, Jan. 31, 2023 /PRNewswire/ — The “Development of Combination Products: Critical Interactions Training Course” conference has been added to ResearchAndMarkets.com’s offering.
Drug/device and device/drug combination products are becoming increasingly important in the medical industry.
The development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging.
This interactive seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical file/design file, explain the biological and synthetic drug regulations and look at the registration procedures for these products.
The programme will cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the CTD. It will also review the key relationships between quality, regulatory, R&D and production.
Delegates will find this a comprehensive overview of the requirements for these 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 regulations
- Understand the registration procedures for devices and medicines in the EU and USA
- Determine the data required for the Common Technical Document (CTD)
- Consider the regulatory strategy depending on your product
- Gain practical advice on how to apply the ISO standards
Who Should Attend:
- 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
Key Topics Covered:
Defining a drug/device and device/drug product
- EU approach
- US approach
Regulatory procedures for drug/device and device/drug products
- EU procedures
- US and Office of Combination Products
Understanding devices
- Medical Device Regulation – EU
- CE marking and Notified Body interactions
- CDRH definitions – US – 510(k) and PMA
- Labelling
- Vigilance requirements
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 regulations
- EU/US definition of medicinal product
- Labelling
- Pharmacovigilance
- Quality requirements
Registration procedures
- EU approach
- US approach
GMP and ISO standards
- Practical application
- Interpretation of the standards
The 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
For more information about this conference visit https://www.researchandmarkets.com/r/j6ijs1
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Research and Markets
Laura Wood, Senior Manager
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