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.
BENEFITS OF ATTENDING
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.
Dr David Jefferys
European regulatory guidance
Defining the regulatory approval route for your productProduct classification
Medical device CE certification – Notified Body expectations
Devices containing ancillary medicinal substance
Highlights of major differences in documentation between:
Quality and non-clinical considerations for combination products
Review of day one
Dr David Jefferys
Clinical trial considerations
FDA’s approach to combination products
Human tissue-engineered products
Post-market surveillance for combination products: vigilance or pharmacovigilance?
David Jefferys (2-3 Apr 2020, 24-25 Sep 2020)
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.
Elizabeth Baker (2-3 Apr 2020)
Dr Elizabeth Baker is Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA. The unit has responsibility for advising on the drug/device borderline, advising on regulatory aspects of drug/device combinations, and undertaking the assessment of data on the medicinal aspects of these combinations on which the MHRA is consulted by Notified Bodies. She has been involved in all stages of the assessment of abridged, new drug and variation applications for medicinal products particularly those in the ophthalmic, dental, surgical and contact lens care categories. Prior to joining the MHRA she was at Pfizer Central Research from 1979.
Alison Wilson (2-3 Apr 2020)
Alison Wilson is an Independent Regulatory Affairs Consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.
Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.
She is now Principal Consultant at CellData Service who provide strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. She has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.
Tina Amini (2-3 Apr 2020)
Dr. Tina Amini is a pharmacist with a PhD in Pharmaceutics from Aston University. She joined Lloyd’s Register as Senior Technical Specialist in 2018. She has previously worked at BSI as the lead Pharmaceutical Expert and Combination Product Specialist for several years.
Tina has been involved in the classification of borderline products and consultation process with several EU competent authorities for device/drug products. Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry for over 17 years in a variety of disciplines where she took products through from discovery to commercialisation.
|2-3 Apr 2020|
|2-3 Apr 2020||Cavendish Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
Until 24 Jan*
|24-25 Sep 2020|
|24-25 Sep 2020||Rembrandt Hotel, London||GBP 1,499.00
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code