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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
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
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
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
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
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
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
MDR’s Impact on Medicinal Product Directive
Documentation Requirements
Presenters
David Jefferys (More...) (1-2 Nov 2021, 10-11 Mar 2022, 7-8 Jun 2022, 29-30 Sep 2022, 14-15 Dec 2022)
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.
Elizabeth Baker (More...) (1-2 Nov 2021, 10-11 Mar 2022, 7-8 Jun 2022, 29-30 Sep 2022, 14-15 Dec 2022)
Elizabeth 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. Prior to joining the MHRA she was at Pfizer Central Research from 1979.
Tina Amini (More...) (1-2 Nov 2021, 10-11 Mar 2022, 7-8 Jun 2022, 29-30 Sep 2022, 14-15 Dec 2022)
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.
Jonathan Hughes (More...) (1-2 Nov 2021)
Jonathan Hughes, Ph.D., FTOPRA, has over 32 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.
Jonathan has hands-on experience in a variety of therapeutic areas and has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, in-vitro diagnostics, software controlled devices and standalone software (including mobile apps). He has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.
Book now
Book now
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1-2 Nov 2021 Live webinar |
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1-2 Nov 2021 Live webinar |
GBP 1,299.00 EUR 1,859.00 USD 2,098.00 + VAT @ 20.00% |
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to attend Live webinar |
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10-11 Mar 2022 Live webinar |
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10-11 Mar 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 3 Feb 22* |
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to attend Live webinar |
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7-8 Jun 2022 Face-to-face, (venue not yet confirmed) |
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7-8 Jun 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 3 May 22* |
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to attend Face-to-face (venue not yet confirmed) |
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29-30 Sep 2022 Live webinar |
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29-30 Sep 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 25 Aug 22* |
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to attend Live webinar |
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14-15 Dec 2022 Face-to-face, (venue not yet confirmed) |
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14-15 Dec 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 9 Nov 22* |
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to attend Face-to-face (venue not yet confirmed) |
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