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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
Practical guidance on borderline Issues and combination products
28-29 Apr 2021
Details
Course overview
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 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.
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.
Programme
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
Defining the regulatory approval route for your product
- Product classification
- 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:
- Device
- 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?
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
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
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 Medical Devices Regulation
Companion diagnostics
- 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
Presenters
Tina Amini (More...)
Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at bsi Notified Body, where she was responsible for Device Drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management System (QMS) as the lead auditor.
Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products.
Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry in a variety of disciplines where she took products through from discovery to commercialisation.
Elizabeth Baker (More...)
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.
David Jefferys (More...)
Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, 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 and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.
Andrew Willis (More...)
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.
Book now
Book now
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28-29 Apr 2021 Live webinar |
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28-29 Apr 2021 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 17 Mar* |
Enrol now Limited places to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code