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8th Pre-Filled Syringes, Injection Devices & Parenteral Systems

  • 21st November 2022
  • ONLINE flag ONLINE

The pre-filled syringes (PFS) market demonstrates a constant growth, and the increasing demand for parenteral drug delivery systems is increasing the numerous technical and regulatory challenges.

The 8th Pre-Filled Syringes, Injection Devices & Parenteral Systems event is aimed to highlight advanced development, manufacturing, quality control, and innovations issues and insights, experienced by the pharmaceutical, medical devices, combination products developers, producers, regulatory and control strategy experts, as well as suppliers of the packaging, related materials, and components.

Attend technical presentations, case studies, interact in Q&A and panel discussions, and leverage practical approaches, perspectives, and collaborations at the Pre-Filled Syringes, Injection Devices & Parenteral Systems (#VLpfs) online conference on November 21, 2022.

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About the 8th Pre-Filled Syringes, Injection Devices & Parenteral Systems (#VLpfs by Vonlanthen)

Pre-filled syringes (PFS) market demonstrates a constant growth due to the following factors and trends:

  • Fast adoption of PFS for delivery of biological medicines, including potential for cell and gene therapies
  • Rapid technological advancements and innovations related to PFS products
  • Spreading allergies and infectious diseases, including COVID-19
  • Increasing number of regulatory approvals related to PFS
  • Expanding collaboration and investments opportunities around PFS manufacturing

With the growing demand for parenteral drug delivery, the numerous technical and regulatory challenges are rising, primarily related to:

  • Strengthening regulatory requirements for PFS manufacturing
  • Manufacturing process complexity of PFS
  • Unique requirements in a CGMP environment designed to formulate, filter, and fill parenteral drugs and combination devices
  • New GMP requirements, coming in force with the revised EU GMP Annex 1 “Manufacture of Sterile Products”
  • Risks related to interaction of PFS components with drug products
  • Aseptic processing of parenterals, sterile packaging materials, and protecting sterile products as well as the patients who use them
  • Quality, safety, compatibility, and stability concerns in the parenteral systems, and effectiveness of PFS
  • Application of emerging technologies and developments connected to PFS and innovative parenteral systems

The 8th Pre-Filled Syringes, Injection Devices & Parenteral Systems event is aimed to highlight advanced development, manufacturing, quality control and innovations issues and insights, experienced by the pharmaceutical, medical devices, combination products developers, producers, regulatory and control strategy experts, as well as suppliers of the packaging, related materials, and components.

Attend technical presentations, case studies, interact in Q&A and panel discussions, and leverage practical approaches, perspectives, and collaborations at the Pre-Filled Syringes, Injection Devices & Parenteral Systems (#VLpfs) online conference on November 21, 2022.

WHO SHOULD ATTEND

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

  • Assembling
  • Automation
  • Biologics
  • Bioprocessing
  • Chemistry, Manufacturing and Controls (CMC)
  • Clean Room
  • Combination Products
  • Compatibility
  • Connected Devices
  • Connected Health
  • Connectivity
  • Design & Engineering
  • Device Development
  • Digital Health
  • Drug Delivery Systems (DDSs)
  • Drug Development
  • Drug Packaging
  • eHealth
  • Emulsions
  • Extractables and Leachables (E&L)
  • Filling Process
  • Filtration Process
  • Formulation
  • Glass
  • Good Manufacturing Practice (GMP)
  • Human Factors
  • Injectable Drugs
  • Injectables
  • Injection Devices
  • Integrity Testing
  • Lyophilization
  • Manufacturing
  • Material Science
  • Medical Devices
  • Monoclonal antibodies (mAbs)
  • Needles
  • Packaging
  • Packaging material
  • Parenteral Drugs
  • Parenterals
  • Pharmaceutical Products
  • Pharmaceutical Injectors
  • Plastic
  • Prefilled Syringes
  • Process Development
  • Processing
  • Quality Assurance (QA)l
  • Quality Control (QC)
  • Raw Materials
  • Regulatory
  • Regulatory Affairs
  • Research & Development
  • Risk Management
  • Robotics
  • Safety
  • Safety, Identity, Strength, Purity, Quality (SISPQ)
  • Smart Devices
  • Sterile Drugs
  • Sterile Production
  • Sterile Products
  • Suspensions
  • Syringe
  • Syringes
  • User Experience (UX)
  • Vaccine Product
  • Vaccines
  • Validation
  • Wearable Injectors

Key Practical Learning Points

  • Regulatory CMC and design control considerations for pre-filled syringes (PFS)
  • Practical insights for developing and manufacturing of PFS, injection devices, and parenteral systems
  • Maintaining compliance with GMP requirements and achieving quality, safety, compatibility, and stability standards in the parenteral systems
  • Exploring recent advancements and comprehensive know-how in process and packaging development of PFS
  • Applying emerging tech, digital, and connected health to PFS, and innovative parenteral systems future outlook

Dr. Tieming Ruan, US

Sr. Director of Device Development

Alexion

Tieming Ruan holds his PhD in mechanical engineering from Ohio State University and an MBA from New York University. Currently, he is senior director of device development at Alexion and led different combination product developments such as auto-injector, pre-filled syringe, and on-body delivery system.

Jim Leamon, US

Director of Biologics Device Development

Jim Leamon is a medical device and drug device combination product development leader with over 30 years of experience. He is the director of biologics device development at Jazz Pharmaceuticals and has worked at Windtree Therapeutics. Early in his career, he worked for device/system development companies that support big pharma. Jim has successfully brought new and effective products to market throughout the world and has developed and implemented new engineering, quality control, and manufacturing processes. He is proficient in CMC drug-device combination product leadership as well as strategic planning, operational excellence, quality systems, design engineering, human factors, manufacturing sciences and engineering, and new product and process development. For the past three years, Jim has performed technical presentations on pre-filled syringes and combination products. 

Dr. Vincenza Pironti, IT

Global Subject Matter Expert, Sterile Drug Products

Thermo Fisher Scientific

Vincenza Pironti has more than 15 years of experience in the pharmaceutical industry, with consolidated experience in business development, product development, sterile manufacturing in aseptic conditions, and for terminally sterilised products. She has extensive knowledge of all phases of product development from formulation screenings to sterile product commercial manufacturing, with expertise in the CMC for small molecules and biologics for injectables.

Dr. Iain Simpson, US

Director, Front-End Innovation

Phillips-Medisize

Iain Simpson is a commercial director at Phillips-Medisize, where he is part of a global team developing industry leading solutions and platforms for drug delivery, digital medicine, and connected health.

He has a degree and PhD in physics both from University College London and an MBE in technology management from the Open University. He has published and presented at conferences on drug delivery, digital biomarkers, healthcare technology, and technology licensing. He is an associate lecturer at the University of Cambridge in bioscience enterprise.

Marieta Duvnjak, CH

Scientific Advisor - Global Lead of Innovation Committee in Analytical Research and Development

Novartis

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, The Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device and pharmaceutical industries. Yvonne leads and oversees research activities and helps clients develop key HFE documents for their design history files. Furthermore, she advises and trains clients on how to apply HFE during product development to meet regulators' expectations. Yvonne holds a BSc in industrial design and an MSc in human technology interaction, both from Eindhoven University of Technology (NL).

Joan Malmstrøm, DK

Principal Scientist

Novo Nordisk A/S

Joan Malmstrøm is a principal scientist at Novo Nordisk A/S who holds a PhD in chemistry from the University of Copenhagen and has 20-plus years of experience with structural elucidation of organic molecules using nuclear magnetic resonance spectroscopy (NMR) and mass spectrometry (MS) as analytical tools. The projects she has been involved in at Novo Nordisk A/S range from small molecules (APIs, raw materials/excipients, etc.) up to peptides/proteins and RNA oligos. During the past years one of her main activities has been the development of NMR analytical methods suitable for analysis of all kinds of molecules included in drug development. The analytical methods are applied on all stages of the development pipeline and GMP validated when needed. She has for many years been the NMR laboratory manager, responsible for maintaining the equipment suitable for use both in the development and manufacturing part of the company. This has included both instrument qualification and IT validation. As head of the CMC technology group within analysis and characterisation, she is involved in exploring new technologies and their implementation.

Asmita Khanolkar, US

Senior Director, Cambridge Pharma/Oval

SMC Ltd

Asmita Khanolkar has a master’s degree in materials science and engineering from Worcester Polytechnic Institute in Worcester, MA (USA). With over 25 years of manufacturing experience specialising in the medical device and pharmaceutical industries, she has managed various device projects from concept to commercial launch. Her product portfolio includes single-use, wearable and implantable devices, drug-device, device-biologic combination products for drug delivery, biotech, biotherapeutics, and pharmaceutical applications. She has held various engineering and management roles in new product development, manufacturing engineering, advanced quality planning, operations, supply chain, and product life cycle management. Her current responsibilities include a corporate leadership role supporting multiple sites for bringing complete solutions to the customers, working closely within the Oval Medical Technologies, Cambridge Pharma, and SMC Ltd. global sites in early technical engagement through commercialisation for combination products and pharmaceutical services.

Tiffany Kay McIntire, CH

Principal Human Factors Engineer

Roche

Tiffany McIntire has been working as a human factors engineer for five years, developing delivery systems and labelling strategies in the pharmaceutical industry. After her studies in industrial/organisational psychology, she started her career at Lilly, where she worked on a range of combination products, including dial-and-dose injectors for insulin, autoinjectors, pre-filled syringes, digital products and an emergency inhalation device. After working at Lilly, she jumped across the pond to Germany, joining a recently established device group within Boehringer Ingelheim. While there, she worked to deepen the team's knowledge of HF and improve their quality management system and vendor management. At the beginning of August, she joined the Roche HF team in Basel, Switzerland, to work with the team there, generating external, scientific publications as well as guiding the team towards best practices in HF.

Dr. Jakob Lange, CH

Head of Account & Business Development

Ypsomed AG

Jakob Lange recently started his position as head of account and business development with responsibility for Ypsomed delivery systems' customer relationships and marketing activities.

Prior to his current role, he has held different positions within marketing and sales as well as in R&D project management. He has been with Ypsomed for more than 16 years.

Jakob holds an MSc degree in chemical engineering from the Royal Institute of Technology in Stockholm, Sweden, and a PhD in polymer science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 40 peer-reviewed papers on medical devices, packaging materials, and polymers.

Louise Place, UK

Director, CMC Regulatory Affairs (Devices)

GSK

Originally training as a pharmaceutical scientist, Louise Place has over 14 years’ experience in drug delivery and medical devices with a focus on device technical management and regulatory strategy for EU and FDA submissions.

Louise joined GSK in May 2020 and leads the device team within CMC regulatory with responsibility for global regulatory and advocacy strategy (devices) across the GSK portfolio. With a solid background in inhalation and parenteral combination products from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

Dr. Christian Proff, CH

Senior Verification Engineer, Device and Packaging Development

Hoffmann-La Roche Ltd

Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S) and Darmstadt (D) Universities of Technology, and a PhD from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory), and Switzerland (Paul-Scherrer-Institut). Within device and packaging development at F. Hoffmann - La Roche, he has been working in verification engineering since 2018 on improvements in CCI testing and development of new device test methods.

Dr. Phil Green, UK

Technical Director

Capa Valve Ltd

Dr. Phil Green is a Mechanical Engineer who has worked in both academia and in industry with a focus on innovative start-up companies developing patented technology. Currently Technical Director of Capa Valve Ltd and also lecturing at Coventry University UK with a passion for developing technology which solves human issues in the simplest way which is often the most considerate to the planet’s resources and the environment. Being the principal pioneer of the D30 impact technology earned him a place as a finalist for the European Inventor of the Year (SME category) in 2019 and through his pedagogical activities he encourages and inspires future generations of engineers to share his passion for innovation and entrepreneurship. 

Dr. Tieming Ruan, US

Sr. Director of Device Development

Alexion

Jim Leamon, US

Director of Biologics Device Development

Dr. Vincenza Pironti, IT

Global Subject Matter Expert, Sterile Drug Products

Thermo Fisher Scientific

Dr. Iain Simpson, US

Director, Front-End Innovation

Phillips-Medisize

Marieta Duvnjak, CH

Scientific Advisor - Global Lead of Innovation Committee in Analytical Research and Development

Novartis

Yvonne Limpens, NL

Managing Human Factors Specialist

Emergo by UL

Joan Malmstrøm, DK

Principal Scientist

Novo Nordisk A/S

Asmita Khanolkar, US

Senior Director, Cambridge Pharma/Oval

SMC Ltd

Tiffany Kay McIntire, CH

Principal Human Factors Engineer

Roche

Dr. Jakob Lange, CH

Head of Account & Business Development

Ypsomed AG

Louise Place, UK

Director, CMC Regulatory Affairs (Devices)

GSK

Dr. Christian Proff, CH

Senior Verification Engineer, Device and Packaging Development

Hoffmann-La Roche Ltd

Dr. Phil Green, UK

Technical Director

Capa Valve Ltd

RECORDING

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What our
participants
are saying

It was a fantastic opportunity for pharmaceutical, medical devices, combination products and packaging experts to catch up on the subjects of pre-filled syringes.

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Attendee

I was impressed by the quality of the presentations on parenterals drug delivery systems, especially it was of my interest the regulatory and control strategy block.

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Attendee

It is a first time I was visiting #VLpfs by Vonlanthen, and I am thankful to the Speakers and the Organizers for such a great opportunity to explore the recent considerations around the injection devices, and to meet new potential partners. I am definitely in to participate again.

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