DUBLIN–(BUSINESS WIRE)–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/hl65vu