2 Day Critical Interactions Training Course (February 20-21, 2023)

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Dublin, Dec. 29, 2022 (GLOBE NEWSWIRE) — 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 program 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/personal vigilance

  • Device experts looking to expand their knowledge to medicines and vice-versa

Key Topics Covered:

Defining a drug/device and device/drug product

Regulatory procedures for drugs/devices and devices/drug products

Understanding devices

  • Medical Device Regulation – EU

  • CE marking and Notified Body interactions

  • CDRH definitions – US – 510(k) and PMA


  • Vigilance requirements

Device technical file/design file

Workshop: Technical file/design file

Understanding the biological and synthetic drug regulations

Registration procedures

GMP and ISO standards


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 labeling

Workshop: regulatory strategy

For more information about this conference visit https://www.researchandmarkets.com/r/27wq8d

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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