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

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

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Dublin, December 29, 2022 (GLOBE NEWSWIRE) — “Developing Combination Products: A Training Course on Critical Interactions” meeting added of ResearchAndMarkets.com Recruitment.

Drug/device and device/pharmaceutical combination products are becoming more and more important in the medical industry.

The development and manufacturing of these products raises many complex issues and the quality and regulatory aspects are difficult.

This interactive seminar will clarify the EU and US approach to drug/device and device/drug combination products, address device technical/design file requirements, and explain the regulation of biological and synthetic medicinal products. , describes the registration procedure for these products.

This program describes the regulatory strategy to be adopted and the relevant aspects of GMP and quality processes, including expected data from the CTD. We also review the important relationships between quality, regulation, R&D and production.

Attendees will find this a comprehensive overview of the requirements for these products and will have the opportunity to discuss intricacies with subject matter experts.

Benefits of joining:

  • Clarify the definitions of drug/device and device/drug combination products in the EU and US

  • Review device technical/design file requirements

  • Comply with biological and synthetic drug regulations

  • Understand the registration procedures for devices and medicines in the EU and US

  • Determine what data you need for your Common Technical Document (CTD)

  • Consider regulatory strategy according to product

  • Get practical advice on how to apply ISO standards

Who Should Attend:

  • All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug)

  • Pharmacovigilance/surveillance personnel

  • Device professionals looking to extend their knowledge to pharmaceuticals and vice versa

Main topics:

Medicine/Device and Device/Pharmaceutical Definitions

Regulatory procedures for drugs/devices and devices/pharmaceuticals

About the device

  • Medical Device Regulation – EU

  • Interaction of CE Marking and Notified Bodies

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

  • labeling

  • vigilance requirement

Device Technical File/Design File

Workshop: Technical File/Design File

Understand the regulation of biological and synthetic drugs

Registration procedure

GMP and ISO standard


Workshop: CTD Requirements – Tracking Critical Documents

Key Considerations for Regulatory Strategy

  • Determining the regulatory route to take

  • Device and product registration

  • Registration of combinations only

  • desired labeling

Workshop: Regulatory Strategy

Find out more about this conference here https://www.researchandmarkets.com/r/27wq8d

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager [email protected] 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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