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)
Device professionals looking to extend their knowledge to pharmaceuticals and vice versa
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
Device Technical File/Design File
Workshop: Technical File/Design File
Understand the regulation of biological and synthetic drugs
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
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