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. 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.
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.
Why you should attend
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.
Programme day one
- Dr David Jefferys
- Life cycle management
European regulatory guidance
- Life expectations of a competent authority
- Impact of the revision to the MDD
- EMA’s viewpoint management
- EU regulatory requirements
Defining the regulatory approval route for your product
- Differences between device containing ancillary medicinal substances and medicinal products
Medical device CE certification - Notified Body expectations
Devices containing ancillary medicinal substance
- Devices containing ancillary human blood derivative
- Post CE marking expectations and changes
Highlights of major differences in documentation between:
- Drug and device
- Device and drug
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?
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
- 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
- How the regulatory guidance impacts companion diagnostics
- What to consider
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
- Pharmacovigilance reporting
- Device vigilance reporting
Mr David Jefferys,
Senior Vice President ,
Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine he worked in clinical and academic medicine, before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.