Drug/Device and Device/Drug Combinations in the EU and USA
Short course
In The Rembrandt Hotel, London
Description
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Type
Short course
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Level
Intermediate
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Location
The rembrandt hotel, london
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Duration
1 Day
The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.
PRE-SEMINAR READING It is recommended that you have read the Medical Device Directives and the Essential Requirements Annex 1 & 3 prior to attending this seminar
Facilities
Location
Start date
Start date
About this course
BENEFITS OF ATTENDING
Understand the European Regulatory Guidance
Know what your Competent Authority expects
Gain an insight into Notified Bodies considerations on drug/device products
Learn how to define the approval route for your product
Clarify the major differences in documentation and approval routes
Consider quality systems requirements for combination products
Discover the FDAs Regulatory approach to combination products
Hear how to deal with Human Tissue Engineered products
Stay up-to-date on Post Market Surveillance for combinations products.
Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.
Introduction/Aim This seminar will focus on the EU regulations for drug/device and device/drug combination products including needle-free, pen and auto injectors in addition to other combination products. It will provide an excellent opportunity for delegates to understand the complex regulations and will assist in establishing the best regulatory route for their product to achieve success in the European market. Delegates will have the opportunity to send specific queries in advance of the event to ensure they are addressed at the seminar.
Reviews
Subjects
- Medical
- Medical training
- Medical Devices
- Pharamaceutical marketing
- Pharma
- Drug Discovery
- Management
- Training planning
- Pharmaceutical Research
- Legal expertise
Teachers and trainers (5)
Alison Wilson
Principal Consultant, Cell Data Services, UK
Dr David Jefferys
Vice President Global Regulatory, Eisai R & D Company, UK
Dr Elizabeth Baker
Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA, UK
Mark Kramer
President, Regulatory Strategies, Inc., USA
Theresa Jeary
Technical Manager, Medical Devices, LRQA Notified Body, UK
Course programme
The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.
PRE-SEMINAR READING It is recommended that you have read the Medical Device Directives and the Essential Requirements Annex 1 & 3 prior to attending this seminar
WHY YOU SHOULD ATTENDBENEFITS OF ATTENDING
- Understand the European Regulatory Guidance
- Know what your Competent Authority expects
- Gain an insight into Notified Bodies considerations on drug/device products
- Learn how to define the approval route for your product
- Clarify the major differences in documentation and approval routes
- Consider quality systems requirements for combination products
- Discover the FDAs Regulatory approach to combination products
- Hear how to deal with Human Tissue Engineered products
- Stay up-to-date on Post Market Surveillance for combinations products.
Drug/Device and Device/Drug Combinations in the EU and USA