Drug/Device and Device/Drug Combinations in the EU and USA

Practical Guidance on Borderline Issues and Combination Products

19-20 Sep 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

The demarcation between medicinal products and devices is becoming evermore important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating a medicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals and medical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.

PRE-SEMINAR READING It is recommended that you have read the Medical Device Directives and the Essential Requirements Annex 1 & 3 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 one

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
  • EMEAs viewpoint management
    Dr Elizabeth Baker

Panel discussion on the 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 two

Companion diagnostics
Dr David Jefferys

Clinical trial considerations
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
    Mark Kramer

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

Post-market surveillance for combination products: vigilance or pharmacovigilance?
Dr David Jefferys

Book now

19-20 Sep 2019
19-20 Sep 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • AbbVie Ltd
  • Allergan Limited
  • Allergopharma
  • Arthrex Inc
  • Biocompatibles UK Ltd
  • Biogen Idec Ltd
  • Camurus AB
  • Catalent Pharma Solutions
  • DCA Design International
  • DePuy International Ltd, T/A DePuy CMW
  • Ferring Pharmaceuticals A/S
  • GALDERMA Recherche & Developpement
  • Glide Pharmaceutical Technologies Limited
  • JensonR+ Ltd
  • LRQA UK
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicologic A/S
  • Mundipharma Middle East FZ-LLC
  • Novo Nordisk
  • Novo Nordisk A/S
  • NTC S.r.l.
  • Orexo AB
  • Owen Mumford Ltd
  • Pfizer Ltd
  • PhaRA BVBA
  • Presspart Manufacturing Ltd
  • PRIMEVIGILANCE ZAGREB D.O.O.
  • ROWENA-CONSULTING
  • Sandoz International GmbH
  • Teva Pharmaceuticals Europe B.V.

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

Cristina Stanca, CMC specialist, MSD

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

Christina Adde, Director Regulatory CMC, Orexo AB

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

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

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

Aleksandra Pajić, Associate PV Project Manager, PrimeVigilance

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

Very informed speakers with vast knowledge.

Christine Fogarty, Regulatory Site Officer (RSO), Sanofi

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

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.

Excellent training with extremely knowledgable and effective speakers. Really feel like I learned a lot in two days.

Karen Ellis, Drug Safety Compliance Manager, Idorsia Pharmaceuticals Ltd

Excellent combination.

Kristiina Pellas, Senior Pharmaceutical Inspector, Finnish Medicines Agency FIMEA

Obviously [all speakers] have a broad experience (including world experience).

Andy Wydler, Senior R&D Program Manager, Actelion Pharmaceuticals

Very good, interesting, good to have different speakers.

Avital Levertov, ‎Regulatory Affairs Manager , Elcam Medical ACA Ltd.

Great location and speakers. Very professionally organised.

Sandra Item, Head RA & Knowledge Management, ISS AG, Integrated Scientific Services

Great speakers, small audience which makes it easier to get in dialogue with the speakers

Liselotte Buron, Senior Manager, LEO Pharma A/S

Overall very good

Arun Sarda, Global Director, QA & Regulatory Affairs, Presspart Manufacturing Ltd

Overall very good program that addressed my needs and gave a good introduction to the field. Very excellent speakers who were really knowledgeable within their field.

Maria Fullerton, Regulatory Senior Scientist, Lundbeck A/S

Very good speakers, well organised.

Anne Leresche, Manager, Merck Group 

The content was complete, presentation were well understanding and speaker were experts

Eva Marcon, Project Manager - Medical Device, DBV Technologies

I found this course very informative and helpful for my area of work, with speakers giving an in-depth yet concise review of each of the topics provided, in a relatively short time frame. Practical examples from the speakers’ experiences allowed a complete understanding of the topics even when these were outside of area of my practice.

Svetlana Agius, Senior Regulatory Affairs Specialist , Alvogen Development Ltd.

Both the speakers and content were excellent. The quantity of information shared and the discussions they generated helped extend understanding of the subject into real world situations. If anything the speakers maybe needed slightly more time as the final presentations were slightly rushed.

Nicola Jordan, Senior Regulatory Specialist, Biocompatibles UK Ltd

Overall the course was very interesting, however the content seemed to focus more on the device/drug combination than the drug/ device combination which would have been of greater interest for me
there were several topics and information our company is not aware of, I believe that attending the course will help to avoid some mistakes with future submissions and post marketing

Juliane Mayerhofer, Int. Regulatory Affairs Manager, Octapharma Pharmazeutika Produktionsges.m.b.H

Theresa Jeary's talks were very interesting and well structure. She has a deep knowledge.

Maria Jose Hijarrubia Ibrahim, Medical Devices Registers, Grifols S.A

Very well organised and professional

Selenge Erdenechimeg, Quality Engineer, Pfizer Ltd

Very informative and engaging and enjoyable

Claire Whitley, Director - Urology, Neurology & CNS TA, Allergan Ltd

The content of the course is particularly focused on regulatory requirements for a EU and US submission, the presentation were clear and the speaker were very open to discussion, as they tried to address all the question coming from the participants.

Ruben Agazzi, Scientist, Chiesi Farmaceutici S.p.A.

Good course

Cristina Cantù, , NTC Srl

Overall good course- very useful information

Ranjith Palvai, Senior Regulatory Affairs Associate , JNJ

The course was well-organized and interactive. Speakers were knowledgeable in addressed topics within the course.

Dr. Fatima Zaid Abu Zanat, Regional Regulatory Affairs Manager, Mundipharma Middle East FZ-LLC

A well delivered, practical course that would equip you with the knowledge to get a good understanding to market

Debbie East-Nuttall, Business Development Manager, LRQA UK

Brilliant meeting with competent, knowledgeable and engaged speakers. I learned a lot

Christina Hansen, Head of Regulatory Affairs, Coloplast A/S

Would recommend it to others, I liked the course

Theresa Larriba Harboe , , Coloplast AS

Useful starting point

Michael Ambuehl, , Actelion Pharmaceuticals Ltd.

Content was good and speakers quite knowledgeable

Mandeep Singh, Senior Development Scientist, Biocompatibles, BTG

Nice, I would come to another training

Ahmed Abdullah Rajab, , Saudi Food and Drug Authority

Content and presentation was good, speakers mostly very good

Rose Le Doux, Quality Engineer, Pfizer Ltd

Professional!

Agnieszka Studzinska, Clinical Group Coordinator, 3M Poland Manufacturing

Worth time out of office. Well managed and organised day. Good content at level I could understand.

Laura Richards, Senior Researcher, MatOrtho Limited

Very useful but very intense course. Not for novices.

Steve Augustyn, Head of Mechanical Engineering, Team Consulting Ltd