The global pre-filled syringes market witnesses an exponential growth owing to the increasing prevalence of chronic diseases and the demand for self-administered drugs.
Today’s patient looks for simplicity, personalization and instant connectivity, when it comes to self-administered injections.
In parallel, the evolution of biologic parenterals creates unique demands and challenges for the development of a custom drug delivery device.
08:30 Registration and Welcome Coffee
09:00 Opening Address from the Chairman
09:10 Future of PFS: How evolving market factors are demanding fundamental innovation in PFS technologies.
Harshal Shah,
Vice President, Global Medical Technology Division, Cambridge Consultants, Boston, USA
09:45 Speed Networking
10:25 High volume injectors: technical and usability considerations
Dr. Jakob Lange,
Account Director, Ypsomed, Basel, Switzerland
11:00 Morning coffee and networking break
11:30 EU MDR Art 117 Impact on pre-filled syringe manufacturer
Outline: With the introduction of the EU MDR, pharma companies must ensure readiness for the implementation in May 2020. However, specifically for single integral medical products with a device component such as a pre-filled syring which are in scope via Art 117 there is still many unknowns. This talk will include an industry perspective as well as case studies of how MDR Art 117 readiness can be approached in this time of uncertainty.
Bjørg Kaae Hunter,
Department Manager RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk, Søborg, Denmark
12:05 Risk Management for Injectable Combination Products.
Davide Mercadante,
Sr. Associate, Product Development Quality (PDQ) – Device Development Quality (DDQ), Biogen, Zug, Switzerland
12:40 Business lunch
13:40 Treatment without arm: Balancing risks, time to market and costs.
Anastasie Formey de Saint Louvent,
European Product Manager, BD Medication Delivery Solutions, Switzerland
14:10 Enabling innovation and managing complexity in Pharma
Dr. Daniel Latham,
Head – Device Development & LCM, Novartis, Basel, Switzerland
14:45 Challenges for High Concentration Biologics Drug Products at the Interface of Formulation, Primary Packaging and Application.
Talk will focus on integrated development approach of high concentration Drug-Device Combination Products. Importance of formulation and stability, container-closure system and application in product development. Special consideration for intravitreal injection including particulate requirements, syringeability and handling consideration for dosing.
Dr. Dhananjay Jere,
Senior Principal Scientist, Principal Group Leader, Lonza Drug Product Services, Basel, Switzerland
15:20 Afternoon coffee and networking break
15:50 Stability management for any product, conditioning and excursive thermal profiles.
Dr. Olivier Brass,
Senior Scientist, Lead of Research Unit, Research Dpt, Sanofi Pasteur, Lyon, France
16:25 A generic manufacturer point of view to use PFS.
Dr. Franz Kainz,
Vice President, Global Contract Manufacturing, Fresenius Kabi, Oberursel, Germany
17:00 Panel Discussion
17:30 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 Human Factors Engineering for Medical Device Development
Rémy Vomscheid,
Director, Device Development & Technologies, Ipsen, Grenoble, France
09:45 Pre-filled syringes for intra-vitreal injections.
Alphons Fakler,
Head Medical Device Risk Management Technical Research and Development, Novartis Pharma AG, Basel, Switzerland
10:20 Morning coffee and networking break
10:50 New disposable auto-injectors development: Design considerations to improve usability.
Four main questions for the development and usability considerations of new disposable auto-injectors:
Adrian von Muralt,
Human Factors Engineer, Novartis, Basel, Switzerland
11:25 Innovative Pre-Filled Syringe (PFS) Solutions for Biotech Drugs.
Dr. Nicolas Eon,
Global Product Manager, SCHOTT, St. Gallen, Switzerland
12:00 Risk mitigation strategies and documentation for extractable, leachable and interactions in PFS
Carsten Worsøe,
Principal Scientist, Novo Nordisk A/S, Copenhagen, Denmark
12:35 Business lunch
13:35 Silicone quantification in injectable drugs – New approaches for QC
Silicone quantification by q-NMR is presented as a more sensitive and faster method compared to traditional techniques. Advantages such as the simplified sample preparation, reduced sample quantity and less matrix influence will be highlighted. The application range of the method and the general procedure are explained in detail and case studies are shown. Content:
Dr. Tino Otte,
Managing Director, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland
13:55 The relationship between ICH guidelines for impurities (M7 & Q3) and extractable & leachable thresholds
Dr. Dvir Doron,
Sr. Chemical Toxicologist, Teva Pharmaceutical Industries Ltd., Israel
14:30 Combi filling – challenges and solutions
Klaus Ullherr,
Senior Product Manager, Syntegon Technology, formerly Bosch Packaging Technology, Germany
15:05 Chairman’s closing remarks and end of day two
15:10 Afternoon coffee and networking break
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Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.
