This seminar will address the European and FDA regulatory requirements, help you define the regulatory route for your product and offer practical guidance on Notified Body expectations, clinical trial considerations and post-market surveillance of borderline products. Participants will have an invaluable opportunity to discuss the complex issues involved with key regulatory experts in this field.
Practical Guidance on Borderline Issues and Combination Products
The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing. At the same time, cell therapy and tissue-engineered products are being combined with both pharmaceuticals and medical devices.
PRE-SEMINAR READING: It is recommended that you have read the Medical Device Directive, Essential Requirements Annex 1 and 3 and the relevant sections on combination products in the new Medical Device Regulation prior to attending this seminar.
Benefits of Attending
Understand the European regulatory guidance
Know what your competent authority expects
Gain 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 FDA's regulatory approach to combination products
Hear how to deal with human tissue-engineered products
Stay up-to-date on post-market surveillance for combination products
Agenda
Programme Day One
Chair'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
EMA's viewpoint management
Dr Elizabeth Baker
Panel discussion
EU regulatory requirements
Defining the regulatory approval route for your product
Product classification
Differences between device containing ancillary medicinal substances and medicinal products
Dr Tina Amini
Medical device CE certification - Notified Body expectations
Devices containing ancillary medicinal substance
Devices containing ancillary human blood derivative
Post CE marking expectations and changes
Dr Tina Amini
Highlights of major differences in documentation between:
Device
Drug and device
Device and drug
Dr Tina Amini
Quality and non-clinical considerations for combination products
Quality, pre-clinical and biocompatibility issues and how to address these for combination products
What kind of non-conformance can we expect if you combine a drug and device?
Dr Tina Amini
Discussion session
Programme Day Two
Review of day one
Dr David Jefferys
Clinical trial considerations
How the regulatory pathway for the final marketed product determines the clinical trial regulations to be followed
Clinical Trials Directive 2001/20/EC - medicines
Requirements for clinical development of medical devices
Clinical data requirements and post-marketing surveillance
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
Mark Kramer
Panel discussion
Compare and contrast EU and USA regulations
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 the development of these products?
Impact of the proposed regulation on medical devices
Alison Wilson
Companion diagnostics
How the regulatory guidance impacts companion diagnostics
What to consider
Dr David Jefferys
Post-market surveillance for combination products: vigilance or pharmacovigilance?
Understanding the differences between medical device vigilance and pharmacovigilance
How to handle the challenges posed by combination products