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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

1-2 Nov 2021

& 10-11 Mar 2022 , 7-8 Jun 2022 , 29-30 Sep 2022 , 14-15 Dec 2022

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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

1-2 Nov 2021
Live webinar
1-2 Nov 2021
Live webinar
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
10-11 Mar 2022
Live webinar
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*
Enrol now
to attend
Live webinar
7-8 Jun 2022
Face-to-face, (venue not yet confirmed)
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*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
29-30 Sep 2022
Live webinar
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*
Enrol now
to attend
Live webinar
14-15 Dec 2022
Face-to-face, (venue not yet confirmed)
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*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • AbbVie Deutschland GmbH&Co.KG
  • AbbVie Ltd
  • AstraZeneca
  • Bayer Healthcare
  • Bespak Europe Limited
  • Biocompatibles UK Ltd
  • Bristows LLP
  • Cambridge Design Partnership
  • Chiesi UK Ltd
  • Coloplast A/S
  • DePuy International Ltd, T/A DePuy CMW
  • Genzyme Ireland Ltd
  • Glide Pharmaceutical Technologies Limited
  • Guerbet
  • Hoffmann-La Roche
  • INSTITUTO GRIFOLS SA
  • Leo Pharma A/S
  • MedAlliance
  • Merck
  • MSD International GmbH
  • Mylan Healthcare GmbH
  • Neuroderm.com
  • Novella Clinical, a Quintiles Company
  • Pfizer R&D UK Ltd
  • Sagentia
  • Team Consulting
  • Team Consulting Ltd
  • Teva Pharmaceuticals Europe B.V.
  • The European Medicines Agency (EMEA)
  • Torbay Pharmaceuticals

Overall very well presented and well thought out. [The speakers] were all very informative and provided very detailed information on the current regulations. A very interesting and worthwhile course.

Mary Day, GMP Medical Device Auditor, Chiesi UK Ltd, Apr 21

All very professional and experts in their field.
Very nice and informative webinar.

Chloë Scheldeman, R&D Manager Scientific Development, 2 Bridge, Sep 20

Good quality content, with hot topics, presented by engaging speakers.

Clara Desvignes, Senior Regulatory Scientist, Voisin Consulting Life Sciences, Sep 20

I am very pleased to attend this webinar. I think that the content is very interesting and the speakers explain themselves in a clear and understandable way.

Silvia Santano Hernandez, Regulatory Affairs Technician, Grifols S.A., Sep 20

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

Brennan Miles, Senior Consultant, 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

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

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

Very informed speakers with vast knowledge.

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

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

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

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