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10th Pre-Filled Syringes, Injection Devices & Parenteral Systems

  • 4th – 5th April 2024
  • Germany flag Germany Munich & Online

The landscape of the pre-filled syringes (PFS) industry is characterised by sustained growth, with a rising demand for parenteral drug delivery systems posing both technical and regulatory challenges.

In response to these dynamic trends, we are delighted to announce the 10th Pre-Filled Syringes, Injection Devices & Parenteral Systems summit, scheduled to take place on April 4-5, 2024, in Munich, Germany. This conference is designed to showcase cutting-edge developments, manufacturing advancements, quality control measures, and innovative solutions encountered by professionals in the pharmaceutical, medical devices, and combination products sectors.

Join a diverse community of developers, producers, regulatory and control strategy experts, as well as suppliers of packaging, related materials, and components. The summit will feature a comprehensive program, including technical presentations, insightful case studies, engaging Q&A sessions, and thought-provoking panel discussions. Attendees will have the opportunity to explore practical approaches, gain valuable perspectives, and foster collaborations that drive the industry forward.

Be a part of the conversation at the forefront of the PFS industry. 

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About the 10th Pre-Filled Syringes, Injection Devices & Parenteral Systems (#VLpfs by Vonlanthen)

Welcome to the 10th Pre-Filled Syringes, Injection Devices & Parenteral Systems Summit (#VLpfs by Vonlanthen), where the dynamic landscape of the PFS industry unfolds.

Driving Forces in PFS Industry Growth:

  • Biological Medicine Revolution: PFS adoption skyrockets for delivering biological medicines, including cutting-edge cell and gene therapies.
  • Tech Marvels: Rapid technological advancements and innovations redefine the PFS landscape, paving the way for enhanced drug delivery systems.
  • Pandemics and Allergies: The global landscape shapes PFS demand, especially with the prevalence of allergies and infectious diseases like COVID-19.
  • Regulatory Green Lights: A surge in regulatory approvals underlines the credibility and safety of PFS applications.
  • Collaboration and Investments: Opportunities abound in collaborative ventures and investments, propelling PFS manufacturing to new heights.

Navigating Technical and Regulatory Complexities:

  • Evolving Regulatory Landscape: Stringent requirements for PFS manufacturing necessitate continuous adaptation to evolving regulatory standards.
  • Manufacturing Intricacies: PFS manufacturing processes face complexities demanding adherence to stringent standards, particularly in CGMP environments.
  • New GMP Mandates: Revised EU GMP Annex 1 introduces new requirements, impacting the formulation, filtration, and filling of parenteral drugs and combination devices.
  • Risk Management: Addressing risks arising from PFS component interactions with drug products is paramount.
  • Aseptic Processing Challenges: Ensuring aseptic processing of parenterals, sterile packaging materials, and safeguarding both products and patients.
  • Quality, Safety, Compatibility: Vigilance against concerns in parenteral systems, ensuring efficacy, compatibility, stability, and overall safety.
  • Embracing Innovation: Application of emerging technologies and developments is crucial for advancing PFS and innovative parenteral systems.
  • Customisation and Patient-Centric Design: Tailoring injection devices to meet the specific needs of patients, including user-friendly designs for self-administration.
  • Sustainability: Growing focus on environmentally friendly materials and sustainable packaging solutions.

10th PFS Summit Highlights:

  • Focussed Insight: Delve into advanced development, manufacturing, and quality control insights crucial for pharmaceutical, medical devices, and combination products.
  • Industry Thought Leadership: Join developers, producers, regulatory experts, and suppliers at the forefront of shaping the future of PFS.
  • Interactive Learning: Engage in technical presentations, case studies, and lively Q&A sessions.
  • Strategic Collaborations: Leverage practical strategies, gain diverse perspectives, and foster collaborations at the summit in Munich, Germany.

Take the opportunity to be part of the dialogue that defines the trajectory of the PFS industry. Secure your spot at the 10th Pre-Filled Syringes, Injection Devices & Parenteral Systems Summit (#VLpfs) for an immersive experience in innovation and collaboration.

Who should attend:

  • Assembling
  • Automation
  • Biologics
  • Bioprocessing
  • Chemistry, Manufacturing and Controls (CMC)
  • Clean Room
  • Combination Products
  • Compatibility
  • Connected Devices
  • Connected Health
  • Connectivity
  • Design & Engineering
  • Design Architect
  • 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
  • Human Factors Engineering (HFE)
  • Industrial Design
  • Injectable Drugs
  • Injectables
  • Injection Devices
  • Integrity Testing
  • Lyophilisation
  • Manufacturing
  • Material Science
  • Medical Devices
  • Monoclonal Antibodies (mAbs)
  • Needles
  • Packaging
  • Packaging Material
  • Parenteral Drugs
  • Parenterals
  • Pharmaceutical Products
  • Pharmaceutical Injectors
  • Plastic
  • Pre-Filled Syringes (PFS)
  • 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
  • Sustainability
  • Syringe
  • Syringes
  • User Experience (UX)
  • Vaccine Product
  • Vaccines
  • Validation
  • Wearable Injectors

Register until February 29

The Early Bird Offer expires in 5 days!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • Cutting-Edge Regulatory Strategies: Unravel the latest regulatory CMC and design control considerations tailored for the ever-evolving landscape of PFS.
  • Innovative Development and Manufacturing Insights: Gain practical, industry-specific insights into the development and manufacturing of PFS, injection devices, and parenteral systems.
  • Ensuring GMP Compliance and Quality Standards: Navigate the complexities of maintaining compliance with GMP requirements, addressing quality, safety, compatibility, and stability standards in parenterals.
  • Process and Packaging Evolution: Explore advancements and gain a comprehensive understanding of the state-of-the-art in process and packaging development for PFS, ensuring you stay at the forefront of industry trends.
  • Designing Sustainable PFS Solutions: Integrating sustainability, enhancing usability, and embracing digitisation for optimal patient compliance and adherence.
  • Future-Ready with Technology: Dive into the application of emerging technologies, digital solutions, and the integration of connected health in the context of PFS.
  • Connected Self-Injection Devices: Using smart PFS to optimise the delivery of drugs and biologics.

Register until February 29

The Early Bird Offer expires in 5 days!

Dr. Marieta Duvnjak, CH

Associate Director - Scientific Advisor I Analytical Research and Development

Novartis

About Speaker

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

About Speaker

Ram Halthore, US

Head of Medical Devices and Combination Products Technical Operations

MSD (Merck Sharp & Dohme Corp.)

About Speaker

Dr. Reza Abedian, CH

Senior Medical Affairs Manager

Gerresheimer

About Speaker

Dr. Deep S Bhattacharya, US

Principal Scientist I Drug Product Design & Development

Pfizer Inc.

About Speaker

Dirk Van Caelenberg, BE

Director, Commercial Development

Advanced Drug Delivery Solutions - BD Medical Pharmaceutical Systems  

About Speaker

Dr Joël Richard, FR

Chief Development Officer

Enterome

About Speaker

Dr. Troels Keldmann, DK

Advisor and Interim Technical Lead

Keldmann Healthcare A/S

About Speaker

Roman Mathaes, CH

Chief Executive Officer

Clear Solutions Laboratories

About Speaker

Ying Wang, UK

Device Development Science Lead, Associate Research Fellow

Pfizer

About Speaker

Glenn Svedberg, SE

Group Sustainability & Technology Director

Nolato

About Speaker

Dr. Nicky Bertollo, IR

CTO & Co-founder

Pharma Latch

About Speaker

Klaus Ullherr, DE

Senior Product Manager

Syntegon Technology

About Speaker

Dr. Markus Balkenhol, DE

Team Leader & Senior Clinical Consultant

AKRA TEAM GmbH

About Speaker

Stefano Pilati, IT

Technical Evaluation and Product Development Coordinator

Stevanato Group

About Speaker

Reto Falk, CH

Director, Account & Business Development

Ypsomed

About Speaker

Thomas Brun, FR

Business Development Services Manager

ZebraSci (a Becton Dickinson Company)

About Speaker

Dr. Marieta Duvnjak, CH

Associate Director - Scientific Advisor I Analytical Research and Development

Novartis

Bringing 10-plus years of industry experience, Marieta Duvnjak is passionate about innovative technology, scientific strategy, innovation, and supporting and connecting people. Marieta is a subject matter expert for in-vitro release method development and in-vitro/in-vivo (cor)relations for long-acting injectables.

Before joining Novartis technical R&D in 2018, she worked on preclinical and clinical development of value-added oral and long-acting generic products at Teva Pharmaceuticals.

Marieta holds a master's degree in drug research and development and PhD in pharmaceutical sciences.

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

Bjarne Sørensen is a director of front-end innovation at Phillips-Medisize, based in the company’s development centre in Denmark. With more than 35 years of experience within product, strategy, and business development, Bjarne has a very visible track record within different business areas. At Phillips-Medisize, he participates in customer projects, typically involving electronic injectors and connected health systems. He is also deeply involved in new electronic platform programs, especially on conceptual, technical, and sustainability aspects.

Ram Halthore, US

Head of Medical Devices and Combination Products Technical Operations

MSD (Merck Sharp & Dohme Corp.)

Ram Halthore has a BS in engineering from the University of Mysore in India and a MS in polymer engineering from the University of Akron, USA.  Ram has over 23 years of experience in the development and commercialisation of medical devices, pharmaceuticals, biologics, and combination products, including contact lenses, ophthalmic devices, pre-filled syringes, inhalation devices, implants, autoinjectors, and on-body injectors. In his current role, Ram is responsible for the lifecycle management of marketed combination products and the commercialisation of new combination products. Before joining Merck, Ram held progressive positions at 3M, Johnson & Johnson, Amgen, and Teva.

Dr. Reza Abedian, CH

Senior Medical Affairs Manager

Gerresheimer

Reza Abedian is currently working as a senior medical affairs manager with Gerresheimer companies. He specialises in medical affairs and clinical research, supporting value-based product development with a strong focus on patient centricity. He holds a PhD in musculoskeletal biomechanics and tissue engineering from Hannover Medical School, laboratory for biomechanics and biomaterials. He has supported several product development/launches and market authorisation of medical devices under FDA, MDD/MDR, and other global market requirements during the past 10 years while having worked in multiple sectors of the medical device and pharma industry.

Since the 2022 fall semester, Reza has been a guest professor at the University of Applied Sciences and Arts Northwestern Switzerland. He is teaching and co-teaching several courses including introduction to QMS, post-market surveillance and combination products module of the masters studies in biomedical engineering at University of Basel.

Dr. Deep S Bhattacharya, US

Principal Scientist I Drug Product Design & Development

Pfizer Inc.

Deep S Bhattacharya has been a principal scientist working with drug product design and development, pharmaceutical R&D (Andover, MA, USA) since November 2019. He received his PhD from the University of Nebraska Medical Center, College of Pharmacy in Pharmaceutical Sciences, with a focus in engineering polymer-protein conjugates and polymeric nanoparticles using computational chemistry, biophysical tools, formulation developments, to in-vivo characterisations in multiple animal models. After joining Pfizer, he has worked with multiple gene therapy, recombinant proteins, and multimodal antibody programs from preclinical through commercialisation. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilising NMR for structural determination of biologics, subcutaneous assessments of biologics, early-stage development of biologics, interfacing with early-stage discovery teams for candidate selection, and business strategies for developments of biopharmaceuticals.

Dirk Van Caelenberg, BE

Director, Commercial Development

Advanced Drug Delivery Solutions - BD Medical Pharmaceutical Systems  

Dirk Van Caelenberg joined BD in 1988 and has since held various roles including sales and product management, key account management, and business development management.

He is currently leading the European business development efforts for BD’s advanced drug delivery solutions, which focusses on partnering with pharmaceutical and biotechnology companies to provide drug delivery solutions and services that help successfully commercialise drug-device combination product therapies.

Dr Joël Richard, FR

Chief Development Officer

Enterome

Dr. Joël Richard is the chief development officer at Enterome, leading CMC, non-clinical, and regulatory activities. He has 30 years of experience in biopharmaceutical R&D, including several previous global senior leadership positions in various biotech and pharma companies, such as MedinCell, Ipsen, Merck Serono, Serono, and Ethypharm. Joël used to be the chief development officer of MedinCell, leading all the drug development operations of the company. Prior to this position, for 10 years Joël led the pharmaceutical development and industrialisation activities of peptides and small molecules for Ipsen.

Joël graduated from Ecole Normale Supérieure (Paris-Saclay, France). He got his PhD in materials science/colloids and interface science from University of Paris and “Habilitation à Diriger les Recherches” (HDR) in chemistry from University of Bordeaux. He also had an entrepreneurial experience, co-funding with professor Jean-Pierre Benoit and leading the Mainelab Company (Angers, France), a drug delivery company specialised in the discovery and development of solvent-free processes for protein delivery systems.

In the past 20 years, Joël has focussed his scientific activities on new formulations and drug delivery systems (such as microspheres, nanoparticles, gelling and self-assembling systems, chemically modified proteins, supercritical fluid technology, etc.), especially for injectable protein and peptide formulations. Joël has published 75 peer-reviewed scientific papers, eight book chapters, and two editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein and peptides formulations, sustained-release formulations, etc.). He is the author of 125 invited international conferences, 50 international communications, and 55 international patent families.

Dr. Troels Keldmann, DK

Advisor and Interim Technical Lead

Keldmann Healthcare A/S

Dr. Troels Keldmann has spent 25 years in the DDS devices and medical devices industry, working cross-functionally covering development, sourcing, innovation, IPR strategy, business development, partnering, and commercialisation. As interim technical lead on injection devices at LEO Pharma A/S, he headed identification, evaluation, and selection of SC injection devices. His prior DDS experience includes co-founding and heading innovative DDS startups, and consulting in DDS devices for pulmonary, nasal, SC (needle/needle-free), and IM delivery. He is an appointed business coach by the European Innovation Council and an industry fellow at Technical University of Denmark. He holds a BSc, MSc and PhD in mechanical engineering and innovation, as well as an MBA.

Roman Mathaes, CH

Chief Executive Officer

Clear Solutions Laboratories

Roman Mathaes is the CEO of Clear Solutions Laboratories. Before that, he was head of pharmaceutical services at Lonza Drug Product Services. In this role, he was responsible for pre-clinical drug product manufacturing for vials, pre-filled syringes, and ampoules. He also led the packaging and combination product development department as well as the lab automation group.

Roman joined Lonza from Roche. He is a pharmacist by training and holds a PhD in pharmaceutical technology from the University of Munich and an MBA. For 10 years he has been a lecturer at the University of Basel (Switzerland) teaching biopharmaceutical product development.

Ying Wang, UK

Device Development Science Lead, Associate Research Fellow

Pfizer

Glenn Svedberg, SE

Group Sustainability & Technology Director

Nolato

Glenn Svedberg has spent 30 years in the manufacturing industry, in managerial and mainly commercial roles. He started at Volvo Group in 1990 as a trainee in purchasing and continued in 1994 to Ericsson as a marketing manager for a production unit. He then moved over to the contract electronics manufacturing industry, where in 1999 he joined Flex in northern Europe, assuming a role as business development director and part of the acquisition team as well as being a key account manager for ABB globally. At Flex he had different roles leading up to becoming managing director for the Scandinavian operations with some 1,400 people in five factories. In 2005 he moved over to the plastic packaging industry and joined Rexam (today part of Berry Global) as a managing director for sites in Sweden and Denmark.

Since 2007 he has been part of Nolato and served as managing director for Nolato Cerbo as well as head of pharma packaging and located in UK for two years when integrating Nolato Jaycare 2012-2014. He is dedicated to lean principles as well as quality and for four years, in parallel to his MD role, he led the medical excellence program across all medical solutions sites, globally. He has a genuine interest in sustainable development and has been laying the foundation for the work leading up to a Ecovadis silver status recognition for Nolato. In June 2021 he assumed the role as group sustainability director at Nolato Group and vice president of business development for medical solutions. Since 2023 he has been heading the technical design centres in three regions: Europe, North America, and Asia.

Dr. Nicky Bertollo, IR

CTO & Co-founder

Pharma Latch

Dr. Nicky Bertollo is a biomedical engineer with over 15 years’ experience in the design, development, preclinical testing, and evaluation of medical devices. He is the inventor of the Latch platform tissue anchorage technology and he’s a medical device innovator with several medical device patents he has led having been licensed. Nicky is a fellow of the New South Wales health medical device commercialisation training program (Sydney, Australia) and holds a BE (mechanical), a masters (biomedical engineering), and a PhD from the University of New South Wales (Sydney, Australia).

Klaus Ullherr, DE

Senior Product Manager

Syntegon Technology

Klaus Ullherr has a degree in engineering and is a senior product manager at Syntegon Technology. In March 2000 he joined Bosch Packaging Technology (which became Syntegon Technology in 2020) as project manager. Since 2002 he has been a product manager for the business field syringes/RTU with global product responsibility. He’s focussed on market analysis, initiating new product developments and business development, and he’s an expert for syringe/nested container processing. He is a member of the PDA and trainer at the PDA syringe training course. Klaus also works as an expert in the DIN/ISO group for primary packaging as well as in the APV, focus group packaging. He’s a member of ISPE and a member of the program committee of the yearly ISPE aseptic conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment.

Dr. Markus Balkenhol, DE

Team Leader & Senior Clinical Consultant

AKRA TEAM GmbH

Markus Balkenhol was educated in dentistry and dental biomaterials sciences. He has several decades of experience in conducting scientific studies, publishing, lecturing, and teaching at different universities. He is an experienced clinical and scientific writer. Markus has comprehensive experience in corporate leadership in the medical device industry. Among others, he was responsible for R&D projects, scientific and clinical affairs and product application. Markus has broad experience in regulatory topics as former clinical expert of a notified body (MDD) and senior clinical consultant of AKRATEAM (MDD & MDR), focussing on clinical and post-market aspects of medical devices including drug device combinations.

Stefano Pilati, IT

Technical Evaluation and Product Development Coordinator

Stevanato Group

Stefano Pilati has a master’s degree in materials engineering at the University of Padova (Italy). He has been working in the primary packaging field for 10 years, focussing on pharmaceutical glass products, combination products, and drug delivery devices. Stefano had the possibility to successfully leading and contributing in developing and commercialising glass vials and pre-fillable syringes for biologic drug products.
With a background in project management in quality assurance, today he leads DCS process development, responsible for overseeing the initial phase of product development projects being the reference for the technical knowledge of processes and materials related to container closure system.

Reto Falk, CH

Director, Account & Business Development

Ypsomed

Reto Falk is a director and leads a team in account and business development for Ypsomed. Reto has extensive experience driving growth as a partner for MedTech, pharmaceutical, and biotech companies.

In 2020, he joined Ypsomed with a focus on fostering and expanding the company’s global customer base.

Reto has more than 25 years of experience in executive global sales and marketing roles with MedTech providers, including Straumann, Camlog, and Geistlich Pharma.

Thomas Brun, FR

Business Development Services Manager

ZebraSci (a Becton Dickinson Company)

Thomas Brun joined ZebraSci (a Becton Dickinson company) in 2021, bringing with him 10 years of experience in medical device and combination product development. He has held various positions, including development engineer, technical lead, and business development. Currently, he is managing the EMEA business development for ZebraSci combination product testing services.

Dr. Marieta Duvnjak, CH

Associate Director - Scientific Advisor I Analytical Research and Development

Novartis

Bjarne Sørensen, DK

Director, Front-End Innovation

Phillips-Medisize

Ram Halthore, US

Head of Medical Devices and Combination Products Technical Operations

MSD (Merck Sharp & Dohme Corp.)

Dr. Reza Abedian, CH

Senior Medical Affairs Manager

Gerresheimer

Dr. Deep S Bhattacharya, US

Principal Scientist I Drug Product Design & Development

Pfizer Inc.

Dirk Van Caelenberg, BE

Director, Commercial Development

Advanced Drug Delivery Solutions - BD Medical Pharmaceutical Systems  

Dr Joël Richard, FR

Chief Development Officer

Enterome

Dr. Troels Keldmann, DK

Advisor and Interim Technical Lead

Keldmann Healthcare A/S

Roman Mathaes, CH

Chief Executive Officer

Clear Solutions Laboratories

Ying Wang, UK

Device Development Science Lead, Associate Research Fellow

Pfizer

Glenn Svedberg, SE

Group Sustainability & Technology Director

Nolato

Dr. Nicky Bertollo, IR

CTO & Co-founder

Pharma Latch

Klaus Ullherr, DE

Senior Product Manager

Syntegon Technology

Dr. Markus Balkenhol, DE

Team Leader & Senior Clinical Consultant

AKRA TEAM GmbH

Stefano Pilati, IT

Technical Evaluation and Product Development Coordinator

Stevanato Group

Reto Falk, CH

Director, Account & Business Development

Ypsomed

Thomas Brun, FR

Business Development Services Manager

ZebraSci (a Becton Dickinson Company)

BROCHURE

Request the 10th Pre-Filled Syringes, Injection Devices & Parenteral Systems brochure and find out the latest topics and ideas that will be shared.

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What our
participants
are saying

The #VLpfs Summit surpassed expectations! Invaluable insights into PFS advancements, regulatory nuances, and collaborative opportunities. A must for industry leaders!

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Attendee

As a regulatory expert, I found the Pre-Filled Syringes Summit by Vonlanthen exceptionally insightful. The discussions on evolving GMP mandates and innovative technologies were enlightening. Kudos to #VLpfs!

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Past

Attendee

A dynamic platform for PFS pioneers! The #VLpfs Summit facilitated meaningful connections, deep dives into manufacturing intricacies, and a forward-thinking approach to the future of parenteral systems.

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Attendee