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

This In-house course provides practical guidance on borderline issues and combination products

In-house Training and Consultancy Services

The demarcation between medicinal products and devices is becoming evermore important. What is more, 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 In-house course will provide practical advice on borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample Programme - Day One

Chairman’s Welcome
Dr. David Jefferys

Introductory Overview

  • Background
  • Life cycle management
  • Exclusivity
  • Patents
    Dr. David Jefferys

European Regulatory Guidance

  • Life expectations of a Competent Authority
  • Impact of the revision to the MDD
  • EMEAs viewpoint
    Dr. Elizabeth Baker

Refreshments

European Regulatory Guidance (continued)
Dr. Elizabeth Baker

Panel Discussion on the EU Regulatory Requirements

Lunch

Defining the Regulatory Approval Route for your Product

  • Product Classification
  • Differences between Device containing ancillary medicinal substances and medicinal products
    Theresa Jeary

Medical Device CE Certification – Notified Body Expectations

  • Devices containing ancillary medicinal substance
  • Devices containing ancillary human blood derivative
  • Post CE Marking expectations and changes
    Theresa Jeary

Discussion

Refreshments

Highlights of Major Differences in Documentation Between

  • Device
  • Drug and device
  • Device and drug
    Theresa Jeary

Quality & Non-Clinical Considerations for Combination Products

  • Quality, pre-clinical and biocompatibility issues; How to address these for combination products
  • What kind of non-conformance can we expect if you combine a drug and device?
    Theresa Jeary

Discussion

End of day one

Sample Programme - Day Two

Review of day one
Dr. David Jefferys

Companion Diagnostics
Dr. David Jefferys

Clinical Trial Considerations
Dr. David Jefferys

FDA’s Approach to Combination Products

  • Requirements for product assignment, pre-market review and post-market regulation
  • Good Manufacturing Practice (GMP) regulation
  • Resources and guidance documents
  • Hints and tips on good approaches
    Mark Kramer

Discussion

Refreshments

FDA’s Approach to Combination Products – (continued)
Mark Kramer

Discussion

Lunch

Human Tissue Engineered Products

  • What are Tissue Engineered and Advanced Therapy Combination Medicinal Products?
  • How are these new borderline products regulated in the EU and US?
  • What are the practical challenges with development of these products?
  • Impact of the proposed Regulation on Medical Devices
    Alison Wilson

Discussion

Refreshments

Post Market Surveillance for Combination Products: Vigilance or Pharmacovigilance?
Dr. David Jefferys

Discussion

Close of meeting