Drug-device combination products represent the next wave of drug delivery devices of increasing complexity. Their development requires a 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.
The call for speakers is open now.
Please find below the tentative schedule. Speaking sessions will be grouped according to similar themes into blocks and published upon finalizing the agenda, so please check back!
08:30 Registration and Welcome Coffee
09:00 Opening Address from the Chairman
09:10 MDR Article 117 implementation and impact on DDC’s
Serge Mathonet,
Global Regulatory Affairs CMC Biologics - Site Leader, Sanofi R&D, Chilly Mazarin, France
09:50 Speed Networking
10:30 Medicinal product incorporating a drug delivery device component: An Industry Perspective on the EU marketing application technical requirements, regulatory review process and post-approval device related change assessment
CMC dossier content strategy and device Post-approval change management
Dr. Carolyn Gordon,
Director, Regulatory CMC, Global Regulatory Affairs, AstraZeneca, United Kingdom
11:10 Morning coffee and networking break
11:40 Regulatory filings for DDC informed by a control strategy approach
Bjørg Kaae Hunter,
Department Manager RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk, Søborg, Denmark
12:20 Using the delivery system concept to streamline drug/device combination approval in EU in accordance with MDR and article 117 requirements.
Dr. Daniel Latham,
Head – Device Development & LCM, Novartis, Basel, Switzerland
13:00 Business lunch
14:00 TREND REPORTING under MDR – Change and Impact.
Learning outcome:
The participants are expected to have a very good understanding of the Trend reporting requirements for medical device under MDR, to have a better overview of the main changes compared to MEDDEV and to return back home with suitable approach and strategy for implementation.
Fayez Abou Hamad,
MD Vigilance Expert – Pharmacist, Complaint & Vigilance Manager, TERUMO EUROPE, Limburg, Belgium
14:40 Life Cycle Management: Exenatide case study.
Michael Noderer,
Associate Principal Scientist, AstraZeneca, Manchester, United Kingdom
15:20 Afternoon coffee and networking break
15:50 Considerations for different types of drug/device Combination Products.
Mark A. Chipperfield, M.Sc, B.Eng.(Hons), AMIMechE, MTOPRA,
Company Director and Principal Consultant, Corvus Device, Holmes Chapel, United Kingdom
16:30 Lifecycle Management of Combination Products.
Combination products, as the term implies, draw from the pharmaceutical and the medical device industries, and force developers and regulators into a complex and challenging evaluation of opportunities and risks. From a commercial perspective, market players act to prolong the commercial life of a product, counter a competitor’s move, increase the products value by offering additional value to the patient, or simply bring a product up to the standard of care. Whatever the change to the product, a series of regulatory, commercial, or supply chain consequences have to be considered to make the effort successful. The presentation is intended to provide insights into the highly dynamic LCM strategie for biologics and biosimilars.
Dirk Kreder,
Founder and CEO, anteris medical GmbH, Munich, Germany
17:10 Panel Discussion
17:40 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:30 Registration and Welcome Coffee
09:00 Opening Address from the Chairman
09:10 Combination Products - regional similarities and differences in GMP.
Dr. Silke Conrad,
Quality Expert Medical Device, Novartis, Basel, Switzerland
09:50 Risk Management for Combination Medical Devices.
Bijan Elahi,
Award Winning International Medical Device Risk-Mgmt Educator, Consultant and author, Medtronic, Eindhoven, Netherlands
10:30 Morning coffee and networking break
11:00 Integration of drug and device: combination product mindset.
Jussi Haikarainen,
Head of Inhalation Technology, Easyhaler Therapy Area, R&D, Orion Corporation - Orion Pharma, Helsinki, Finland
11:40 Design Control, Human Factors and Risk Management. An integrated approach.
Davide Mercadante,
Sr. Associate, Product Development Quality (PDQ) – Device Development Quality (DDQ), Biogen, Zug, Switzerland
12:20 Entering a new market – aspects of ensuring patient centricity.
Fie Falck Larsen,
Senior Usability Engineer, LEO Pharma, Copenhagen, Denmark
13:00 Business lunch
14:00 Life Cycle Management of the Soft Mist Inhaler Respimat®.
Dr. Raphael Krampe,
Scientist, Boehringer Ingelheim microParts, Ratingen, Germany
14:40 A case study of large-volume device manufacture using a bi-functional membrane.
Henry R. Charlton,
Global Marketing Director – Medical OEM, Pall Corporation, London, United Kingdom
15:00 Drug-device compatibility: Where is the guideline?
Dr. Ir. Lise Vanderkelen,
Department Head Pharma and Microbiology, Nelson Labs Europe, Tervuren, Belgium
15:40 Afternoon coffee and networking break
16:10 Chairman’s closing remarks and end of summit
To register to the summit as Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com
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Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
▸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.
