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

Practical Guidance on Borderline Issues and Combination Products

14-15 Mar 2019

& 19-20 Sep 2019

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 21 Dec

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

Presenters

David Jefferys (14-15 Mar 2019)

Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine 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, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.

Elizabeth Baker (14-15 Mar 2019)

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 (14-15 Mar 2019)

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.

Mark Kramer (14-15 Mar 2019)

Dr Mark Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, he was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.

He is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.

Tina Amini (14-15 Mar 2019)

Dr. Tina Amini is a pharmacist with a PhD in Pharmaceutics from Aston University. She joined Lloyd’s Register as Senior Technical Specialist in 2018. She has previously worked at BSI as the lead Pharmaceutical Expert and Combination Product Specialist for several years.

Tina has been involved in the classification of borderline products and consultation process with several EU competent authorities for device/drug products. Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry for over 17 years in a variety of disciplines where she took products through from discovery to commercialisation.

Book now

14-15 Mar 2019
14-15 Mar 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 21 Dec
Enrol now
19-20 Sep 2019
19-20 Sep 2019 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Allergan Limited
  • Alvogen Development Ltd.
  • Baxter AG
  • Bayer Healthcare
  • Besins Healthcare
  • Biogen Idec Ltd
  • BONESUPPORT AB
  • Bristows LLP
  • Coloplast A/S
  • CSL Behring GmbH
  • Ferrer Internacional S. A.
  • Glide Pharmaceutical Technologies Limited
  • Grifols S.A.
  • Guerbet
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicologic A/S
  • Menarini Ricerche
  • Neuroderm.com
  • Novella Clinical, a Quintiles Company
  • Novo Nordisk
  • Philips
  • ROWENA-CONSULTING
  • Sandoz International GmbH
  • Sanofi-Aventis
  • Servier International
  • Syntacoll GmbH
  • Takeda Pharma A/S
  • TEVA Abbotts Park
  • Teva Pharmaceuticals Europe B.V.
  • Vectura Ltd

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

Aleksandra Pajić, Associate PV Project Manager, PrimeVigilance

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.

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

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

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

Very informed speakers with vast knowledge.

Christine Fogarty, Regulatory Site Officer (RSO), Sanofi

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

Excellent combination.

Kristiina Pellas, Senior Pharmaceutical Inspector, Finnish Medicines Agency FIMEA

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

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

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

Overall very good

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

Great location and speakers. Very professionally organised.

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

Very good, interesting, good to have different speakers.

Avital Levertov, ‎Regulatory Affairs Manager , Elcam Medical ACA 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

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

Liselotte Buron, Senior Manager, LEO Pharma A/S

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

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

Eva Marcon, Project Manager - Medical Device, DBV Technologies

Very good speakers, well organised.

Anne Leresche, Manager, Merck Group 

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

Good course

Cristina Cantù, , NTC Srl

Very informative and engaging and enjoyable

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

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

Overall good course- very useful information

Ranjith Palvai, Senior Regulatory Affairs Associate , JNJ

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.

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

Laura Richards, Senior Researcher, MatOrtho Limited

Would recommend it to others, I liked the course

Theresa Larriba Harboe , , Coloplast AS

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

Content was good and speakers quite knowledgeable

Mandeep Singh, Senior Development Scientist, Biocompatibles, BTG

Professional!

Agnieszka Studzinska, Clinical Group Coordinator, 3M Poland Manufacturing

Very useful but very intense course. Not for novices.

Steve Augustyn, Head of Mechanical Engineering, Team Consulting Ltd

Useful starting point

Michael Ambuehl, , Actelion Pharmaceuticals Ltd.

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

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

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