Drug/device combination products represent the next wave of drug delivery devices of increasing complexity. Their development requires the number of technical challenges to consider - integrating drug and device systems, defining the elements of design control, determining quality systems and manufacturing processes. It is also critical to establish a regulatory and clinical strategy from early on in development. Our meeting facilitates a better understanding of both regulatory and practical aspects of developing drug-device combinations, as well as the management of combination products across the total product life cycle.
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 MDR and the impact on combined drug-device products - Latest Status.
Mark A. Chipperfield, M.Sc, B.Eng.(Hons), AMIMechE, MTOPRA,
Company Director and Principal Consultant, Corvus Device, Holmes Chapel, United Kingdom
09:20 Speed Networking
10:00 MDR Art 117 advocacy update.
Bjørg Kaae Hunter,
Department Manager RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk, Søborg, Denmark
10:40 Morning coffee and networking break
11:10 Driving innovation to extend your combination product lifespan – focus on devices for self-injection.
This presentation will start with a market overview and then cover current trends in the self-injection area including as the move towards platform-based developments and the drive for digitalization. Different options for Life Cycle Management of a device combination product will be discussed, such as the addition of further mechanical device features, updates to the industrial design and modular addition of smart / connected functionalities. The talk will end with a case study presenting usability work conducted using eye tracking on a reusable connected add-on for an autoinjector.
Dr. Jakob Lange,
Account Director, Ypsomed, Basel, Switzerland
11:50 Analytical approaches for determination of Leachables and Impurities in Combination Products.
Combination products often contain different types of polymeric construction materials and therefore they are often associated with an increased risk of the presence of Leachables. In many cases large contact surfaces of the different materials are exposed to relatively small volumes of drug formulations which further increases the risk of unwanted interactions.
Moreover, special combination products such as drug eluting stents and other devices with a functional coating are used more frequently. For such products a precise and robust determination of very small levels of coating-related impurities is essential.
In this presentation effective strategies for performing Extractables and Leachables investigations on combination products will be shown including case studies which illustrate the application of such strategies in the daily practice.
In addition, a highly sensitive determination method for volatile and semi volatile impurities will be introduced, which is directly applied to coated devices in order to determine process related impurities in a quantitative way under GMP without the need of complicated, time intensive and often error-prone sample preparation procedures
Dr. Tino Otte,
Senior Scientific Consultant, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland
12:30 Business lunch
13:30 Platform selecting and engaging the right stakeholders in the product development process.
Elise Legendre,
Head of PFS/LVD Late Stage Development, MED Primary Container Development, Sanofi, Rouen, France
14:10 Workshop.
This workshop will provide an overview of the journey and lessons learnt by the first company to achieve a certification of their QMS system and product against the EU MDR. The presentation will be focused in two parts – firstly an overview of the adaptation of the quality system to incorporate and address the elements required under the MDR followed by a discussion and reflection of the challenges and strategies used to successful upgrade and certify an inhaler device platform supporting both commercial and development products.
Marco Prado,
Global Head Quality Medical Devices - NTO BT&A QMS, Novartis Pharma AG, Basel, Switzerland
David Roe,
Global Technical Steward, NTO Manufacturing Science & Technology, Novartis Pharma AG, Basel, Switzerland
15:30 Afternoon coffee and networking break
16:00 Combination product control strategy.
Shruthi Vidyasagar,
Device Development Lead, Device Engineering, GSK, London, United Kingdom
16:40 Panel Discussion
17:30 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 The re-usable Respimat – Eco-friendly Inhaler with robust technical performance and improved usability.
Dr. Raphael Krampe,
Scientist, Boehringer Ingelheim microParts, Ratingen, Germany
09:20 Understanding a device framework - risk management, design controls, and systems complexity.
Davide Mercadante,
Sr. Associate, Product Development Quality (PDQ) – Device Development Quality (DDQ), Biogen, Zug, Switzerland
10:00 Morning coffee and networking break
10:30 Case studies on utilizing human factors in combination products risk management.
James Meehan,
Associate Principal Scientist, AstraZeneca, United Kingdom
11:10 Can a “platform approach” support Human Factors activities?
Nicholas Stones,
Senior Device Manager - Human Factors, Novartis Pharma AG, Basel, Switzerland
11:50 Business lunch
12:50 Medical Device Vigilance system under MDR - Basics and Approach for Implementation.
Fayez Abou Hamad,
MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager, TERUMO EUROPE, Limburg, Belgium
13:30 Development of Drug Device Combination Products: Nonclinical safety requirements.
Dr. Clemens Günther,
Director Nonclinical Safety Consumer Care, Bayer AG, Berlin, Germany
14:10 Beginning with the end in mind – Combination Product Testing
Daniel L. Bantz,
Technology Manager, Packaging & Performance, West Pharmaceutical Services, Inc., Switzerland
14:50 Chairman’s closing remarks and end of day two
15:00 Afternoon coffee and networking break
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Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
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▸AbbVie ▸Ablynx ▸anteris medical ▸AOP Orphan Pharmaceuticals ▸Astellas Pharma ▸AstraZeneca ▸BIOCORP ▸Biogen ▸Boehringer Ingelheim microParts ▸Bristol-Myers Squibb ▸BSI Group ▸Corvus Device ▸Cytel ▸Design Science ▸Eli Lilly ▸Freelancer ▸GSK ▸H&B Electronic ▸H&T Presspart ▸Hanway Associates ▸Janssen ▸LEO Pharma ▸Maetrics ▸Medac ▸Medtronic ▸Nelson Labs ▸Nelson Labs Europe ▸Novartis ▸Orion Corporation - Orion Pharma ▸Pall Life Sciences ▸Pharmathen ▸Progress-PME ▸Regeneron Pharmaceuticals ▸Sanofi R&D ▸Sanofi-Aventis ▸sfm medical devices ▸Sharp Clinical Services ▸Spiegelberg ▸TERUMO EUROPE ▸tesa Labtec ▸Teva ▸UPM Raflatac
chaired a panel discussion with speakers from TERUMO EUROPE, Novartis, anteris medical GmbH, GlaxoSmithKline, AstraZeneca and Corvus Device.
