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Drug/Device and Device/Drug Combinations in the EU and USA


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Who should attend?

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.

Details

Course overview

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 attend

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.

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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