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Drug/Device and Device/Drug Combinations in the EU and USA Training Course: face to face & live webinar

Practical guidance on borderline Issues and combination products

24-25 Sep 2020

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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 - day 1

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

Programme - day 2

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 

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 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
  • Pharmacovigilance reporting
  • Device vigilance reporting
    Dr David Jefferys

Presenters

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.

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.

Alison Wilson (More...)

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 (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.

Book now

  attend Face to face attend Live webinar
24-25 Sep 2020, Rembrandt Hotel, London
24-25 Sep 2020 Rembrandt Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 13 Aug*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 13 Aug*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • 3M Poland Manufacturing
  • Allergan Limited
  • Ares Trading SA
  • Astellas Pharma Europe BV
  • Bristows LLP
  • Cochlear Limited
  • CYTON BIOSCIENCES LTD
  • Danish Medicines Agency
  • Dermal Laboratories Ltd
  • FAES Farma SA
  • Ferring International Center SA
  • Ferring Pharmaceuticals A/S
  • Genzyme Ireland Ltd
  • Guerbet
  • Iceblack
  • InQpharm Group Sdn Bhd
  • JensonR+ Ltd
  • MatOrtho Ltd
  • Meda Pharmaceuticals Limited
  • medac GmbH
  • MSD International GmbH
  • NTC S.r.l.
  • PhaRA BVBA
  • Sandoz International GmbH
  • Servier International
  • Takeda Pharma A/S
  • Team Consulting Ltd
  • TEVA
  • The European Medicines Agency (EMEA)
  • Vectura Delivery Devices Ltd

Excellent delivery, very knowledgeable speakers and a great forum altogether. I wanted to gain an understanding of the quality and regulatory aspects of combined devices and I came away very pleased with the delivery, contents, and discussion we had during the course. I believe I am now equipped better to do my job as a quality engineer in a medical devices consulting company. I'd like to thank the speakers for sharing their expertise and experiences in such a graceful and professional manner.

Ana Burman, Quality Engineer, Team Consulting, Sep 19

All my expectations were met, including good venue and excellent organization! It was great to have so many expert speakers from regulatory agencies and notified bodies, which always makes a big difference. I particularly liked the competence of the speakers and their willingness to answer participants' questions, that it was a very interactive course, and that we received hard copies of the presentations.

Beate Schmidt, Consultant Regulatory Affairs, benefits Regulatory Consulting, Sep 19

The course accurately met my expectations with regard to content and quality – it was very good!

Brennan Miles, Senior Consultant, Team Consulting, Sep 19

The course was good and the presenters very experienced and knowledgeable.

Mina Patel, RA Manager, Medtrade Products Limited, Sep 19

A very comprehensive well presented course providing information on classifying combination products & issues to be considered when applying for a licence.

Sally Andrews, Head of Regulatory Affairs, Torbay Pharmaceuticals, Mar 19

Well organised and would recommend to colleagues.

Roisin Slevin, Regulatory Affairs, Veryan Medical Ltd, Mar 19

Excellent training, I've received answers/advice to specific issues

Aleksandra Pajić, Associate PV Project Manager, PrimeVigilance, Oct 18

Being new to the drug device area, the course gave a very good introduction to this field, with clear presentations and expert speaker(s) in the field.

Vasilios Dabouras, GRA CMC Manager , CSL Behring GmbH, Oct 18

Speakers were all skilled in their specific topic and easy to listen to.

Christina Adde, Director Regulatory CMC, Orexo AB, Oct 18

Very informed speakers with vast knowledge.

Christine Fogarty, Regulatory Site Officer (RSO), Sanofi, Oct 18

The course was detailed and presented by individuals who had a wealth of experience within the industry. The information provided was concise and you did not feel overloaded with information. The presentations were delivered at a good pace.

Ashleigh Wilson, PDQA Associate, Teva NI ltd., Oct 18

The speakers were very knowledgeable and willing to answers any question.

Ivona Murvaj, Senior PV Regulatory Associate, PRIMEVIGILANCE ZAGREB D.O.O., Oct 18

Well structured, good information, prepared speakers who answered all our questions.

Cristina Stanca, Senior CMC specialist, Pharmedd Services Ltd, Oct 18

Comprehensive overview of the drug/device and device/drug regulations in Europe and the US. Very clear and engaging presentations given by speakers with a massive experience on the field. Highly recommendable to anyone interested on this topic.

Maria J Fernandez-Lozano, Senior Biologics Development Manager, Diamond BioPharm Limited, Oct 18

The course was well organized and the speakers were highly prepared. I had great insights on the overall process in terms of regulations, differences between FDA and EU as well as upcoming changes.

Valentina Squitieri, Senior Quality Manager, Idorsia Pharmaceuticals Ltd, Oct 18