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PFS & Injectable Drug Devices Europe
13 January - 15 January 2026
PFS & Injectable Drug Devices Europe

Kick off 2026 and set the tone for the year at 18th Annual Pre-Filled Syringes and Injectable Drug Devices Conference!

Join us in London next January where we will unite leaders and innovators from the device development industry. This highly anticipated conference offers unparalleled opportunities to explore the latest advances in combination product technology, share insights, and foster collaboration across a dynamic three-day program.

As part of SAE’s leading Injectable Drug Delivery Series, the event features:

  • Pre-Conference Focus Day: PFS Design for Enhanced Drug Delivery
  • Two-Day Main Conference: Morning keynote plenaries and afternoon parallel topic streams addressing the industry’s most pressing challenges, including:
    • Large-Volume Drug Delivery Solutions
    • Sustainability in Medical Devices
    • Advancements in Primary Drug Container Development and Biocompatibility
    • Digital Health Technologies and Connected Devices

This conference not only provides actionable insights to elevate your injectable device portfolio but also offers invaluable networking opportunities with key players across the industry.

Mark your calendar and be part of this must-attend event in January 2026. We look forward to welcoming you to London!
 

FEATURED SPEAKERS

Abby Lambretti

Abby Lambretti

Senior Scientist II, AbbVie
Andreas  Emmendoerffer

Andreas Emmendoerffer

Principal Regulatory Program Director, Roche
Andrew Chapman

Andrew Chapman

Senior Director, AstraZeneca
Anja Hartmann

Anja Hartmann

Lead Auditor / Product Specialist, TUV SUD Product Service GmbH
Berengere Paris

Berengere Paris

Regulatory Affairs Specialist, RA Devices, Novo Nordisk
Berengere Paris

Berengere Paris

Regulatory Affairs Specialist, RA Devices, Novo Nordisk
Berna Kosekaya

Berna Kosekaya

Regulatory Professional, RA CMC & Devices/RA Device, Novo Nordisk
Cedric Gysel

Cedric Gysel

Chief Changemaker, Be Circular
Charles  Potter

Charles Potter

Project and Technical Leader, Chiesi Ltd
Charles  Potter

Charles Potter

Technical and Project Leader, Chiesi Ltd
Conor O'Neill

Conor O'Neill

Head of Packaging Development and Design, GSK
Courtney Soulsby

Courtney Soulsby

Global Director, Healthcare and Life Sciences, BSI
Credence MedSystems - Senior Representative

Credence MedSystems - Senior Representative

, Credence MedSystems, Inc.
David Harrison

David Harrison

Business Lead, Drug Products and Devices, UCB
David Harrison

David Harrison

Business Lead, Drug Products and Devices, UCB
Farshad Ramazani

Farshad Ramazani

Formulation Project Leader Senior Expert Science and Technology, Novartis Pharma AG
Fatima Bennai-Sanfourche

Fatima Bennai-Sanfourche

Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer
Fatima Bennai-Sanfourche

Fatima Bennai-Sanfourche

Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer
George Moore-Arthur

George Moore-Arthur

Senior Global Regulatory Professional, Novo Nordisk
Jacob Moberg Sandager

Jacob Moberg Sandager

Senior Circular Plastic Engineer, Novo Nordisk
Javad Jabbari

Javad Jabbari

Director Regulatory Affairs RA Device and Combination Products, Ascendis Pharma
Javad Jabbari

Javad Jabbari

Director Regulatory Affairs RA Device and Combination Products, Ascendis Pharma
Jussi Haikarainen

Jussi Haikarainen

Director, Device Development , AbbVie
Kristine Berkenhoff

Kristine Berkenhoff

Head of Laboratory, Boehringer Ingelheim Pharma GmbH & Co. KG
Louise Place

Louise Place

Director, Devices, Global CMC Regulatory Affairs, GSK
Marc Egen

Marc Egen

Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG
Mario Hirth

Mario Hirth

Director Global Verification Testing, AbbVie
MGS - Senior Representative

MGS - Senior Representative

, MGS Mfg. Group, Inc
Rachel Koppelman

Rachel Koppelman

Head of Device Engineering, Sandoz
Rachel Koppelman

Rachel Koppelman

Head of Device Engineering, Sandoz
Richard Crowther

Richard Crowther

Sr Manager Regulatory Affairs, Amgen
Richard Wedge

Richard Wedge

Associate Research Fellow, Pfizer
Sandra Einemann

Sandra Einemann

Customer Relationship Manager, TUV SUD Product Service GmbH
Senior Representative

Senior Representative

, To be confirmed
Simon Wilson

Simon Wilson

Device Development Lead, Pfizer
Soren Skov

Soren Skov

Senior Human Factors Engineer, Roche
Steve Hoare

Steve Hoare

Deputy Director, Partnerships, Medicines and Healthcare products Regulatory Agency (MHRA)
Tarja Nurmi

Tarja Nurmi

Senior Expert, Extractables & Leachables, Bayer
Theresa Jeary

Theresa Jeary

Global Head, Medicinal & Biologics Team, BSI
Theresa Jeary

Theresa Jeary

Global Head, Medicinal & Biologics Team, BSI
Thomas Wejs Moller

Thomas Wejs Moller

Senior RA Policy Director, Novo Nordisk
Tiffany McIntire

Tiffany McIntire

Device Team Leader, Roche
Tony Haythornthwaite

Tony Haythornthwaite

Associate Director Device Engineering, GSK
Tony Haythornthwaite

Tony Haythornthwaite

Associate Director Device Engineering, GSK
Xavier Donnette

Xavier Donnette

Device Program Lead, UCB
Ying Wang

Ying Wang

Device Development Science Lead, Associate Research Fellow, Pfizer

Abby Lambretti

Senior Scientist II, AbbVie
Abby Lambretti

Abby Lambretti, MBA, is a scientist at AbbVie with over 7 years’ experience leading global combination product and drug delivery device development teams across the US and EU. Specializing in therapeutic areas such as aesthetics, neurotoxins, eyecare, and immunology, she drives innovation in microneedle patches, injectables, and prefilled syringes following the principles of design control. In her current role as engineering program manager, Abby is recognized for motivating diverse, cross-functional teams and delivering impactful results, advancing combination product devices from concept to clinical readiness.

Althena Medical - Senior Representative

, Althena Medical
Althena Medical - Senior Representative

Andreas Emmendoerffer

Principal Regulatory Program Director, Roche
Andreas  Emmendoerffer

Andreas Emmendörffer is a Senior Regulatory Affairs Professional with a strong background in Quality Assurance, Operations, and Life Science. As a Medical Doctor and PhD, he has over 25 years of international experience in regulatory affairs and quality assurance, focusing on medicinal products, combination products, and medical devices. His expertise includes immunology, oncology, and ensuring regulatory compliance with global health authorities such as the FDA and EMA.

In his current position as a Principal Regulatory Program Director at Roche, he has been the device regulatory lead for two successful global submissions (ENSPRYNG and EVRYSDI). He also has people leadership responsibilities for global submissions in the fields of ophthalmology, neurology, and oncology. His career is further distinguished by a profound entrepreneurial background with biotech and medtech start-ups and direct leadership of international teams.

Andrew Chapman

Senior Director, AstraZeneca
Andrew Chapman

Andrew Chapman, BEng, MBA, is a Senior Director at AstraZeneca in Biopharmaceutical Development, where he leads technology strategy and the evaluation, development and commercialisation of drug delivery technologies.
With over 21 years of experience developing breakthrough technologies for some of the world's largest pharmaceutical and medical technology companies, Andrew is known for his strategic thinking, clear communication, and adaptive leadership. Holding degrees in both engineering and business he is passionate about improving patients' lives through technological innovation.
Andrew's professional journey includes diverse roles ranging from project leadership to setting and executing organization-wide strategies, along with P&L responsibility for multimillion-dollar divisions. He has led strategic consulting projects in medical devices, connected devices, and digital health for industry leaders such as AbbVie, Roche, CSL Behring, Smith & Nephew, and Zimmer Biomet. Before joining AstraZeneca, Andrew served as Vice President at Sagentia and as Head of Digital Health at the UK government’s Digital Catapult.

Anja Hartmann

Lead Auditor / Product Specialist, TUV SUD Product Service GmbH
Anja Hartmann

I’m a biomedical engineer working at TÜV SÜD Product Service in the department of non-active medical devices as a Lead auditor for ISO 13485, ISO 9001, MDR, MDSAP and other country specific regulations. Furthermore, I’m a Reviewer of Technical Documentation including Clinical evaluation and a Senior Product Specialist for Pen injectors. In addition, I’m the Process Owner of Article 117 MDR and I have a large experience in issuing of NB Opinions for DDCs.

 

Berengere Paris

Regulatory Affairs Specialist, RA Devices, Novo Nordisk
Berengere Paris

I am a Regulatory Affairs Specialist, PharmD with over 12 years of experience in CMC, Device and Drug Device Combination regulatory functions. I have spent the last 5 years at Novo Nordisk specializing as a regulatory device lead in development of device delivery solutions for injectable drugs.
 

Berna Kosekaya

Regulatory Professional, RA CMC & Devices/RA Device, Novo Nordisk
Berna Kosekaya

BioPhorum - Senior Representative

, BioPhorum
BioPhorum - Senior Representative

Cedric Gysel

Chief Changemaker, Be Circular
Cedric Gysel

Charles Potter

Project and Technical Leader, Chiesi Ltd
Charles  Potter

Charles has more than 30 years experience in the drug delivery industry. He has been employed for the last four years as part of the device development team at Chiesi, an Italian family owned pharmaceutical company with a turnover of ~€3bn. Chiesi is a leader in respiratory medicines and has an expanding range of rare disease products which utilize a range of delivery technologies.

However, most of Charles’ career has focused on novel injectable technologies. Following an engineering degree, Charles joined PowderJect Pharmaceuticals and saw it grow from 4 to >1,000 employees. He then founded and was CEO of Glide Pharma for 12 years before working as an independent consultant with a portfolio of companies which were either developing a proprietary drug delivery technology or were selecting a delivery technology for their novel compound.
 

Conor O'Neill

Head of Packaging Development and Design, GSK
Conor O'Neill

I lead the Packaging Development & Design group in GSK R&D’s Drug Product Development department. My group is responsible for the selection of the immediate or primary contact packaging components for GSK’s portfolio of small and large molecule projects in development ensuring the suitability and safety of these components with the drug product through to regulatory filing and market launch.

I am passionate about improving the sustainability perceptions around pharmaceutical and delivery device packaging. Within GSK R&D I am leading the evaluation of novel materials and systems that will enable our corporate intent to reduce the environmental footprint of our products and packaging. I am driven by the ambition to improving the circularity of the devices and packaging we ask our patients to use.

I graduated from the University of Limerick, Ireland, as an Applied Physicist and I joined GSK’s then Device Technology Group in Inhaled Product Development in 2003. I began my career as a Device Technologist supporting and subsequently leading the design verification for the MistPro platform - used for the delivery of the Veramyst/Avamys product. During my career I have worked across the primary and secondary packaging space in both our R&D and Global Supply Chain organisations. I have supported multiple product developments and launches ranging across respiratory treatments, infectious diseases, oncology. and rare diseases.
 

Courtney Soulsby

Global Director, Healthcare and Life Sciences, BSI
Courtney Soulsby

Courtney Soulsby works as a Global Director for the Healthcare and Life Sciences sector team for BSI (British Standards Institution), focusing on healthcare sustainability. Courtney has worked with pharmaceutical and med tech industries and their supply chain for over ten years – with a deep understanding the issues with regulation, environment, security, compliance, quality, and other risk exposures when manufacturing and transporting healthcare products.

Credence MedSystems - Senior Representative

, Credence MedSystems, Inc.
Credence MedSystems - Senior Representative

Crux Product Design - Senior Representative

, Crux Product Design
Crux Product Design - Senior Representative

David Harrison

Business Lead, Drug Products and Devices, UCB
David Harrison

David J Harrison is a business lead, operations head, novelist, and senior director within biopharma and medical devices, although not necessarily in that order. Amongst his sources of inspiration, he lists his wife and family at the very top, not too closely followed by Vonnegut, Murakami, and Bowie.


Over the last twenty-five years, David is delighted to have contributed towards some important medicines, most of which require novel and innovative medical devices, often surrounded by carefully designed eco-systems. He believes in the power of partnerships to create lasting value for patients.


David was the joint recipient of the 2020 PDA Innovation award. His first novel, Recursion, was published in 2021.


You can follow David on LinkedIn (linkedin.com/in/harrisondavid), and Instagram (@davidjharrisonwriter).
 

DCA - Senior Representative

, DCA
DCA - Senior Representative

Farshad Ramazani

Formulation Project Leader Senior Expert Science and Technology, Novartis Pharma AG
Farshad Ramazani

Dr. Farshad Ramazani is a Senior Expert Science and Technology at Novartis Pharma AG in Basel, Switzerland, specializing in parenteral drug development. He has been instrumental in developing several patient-centric long-acting injectable formulations, now in various clinical trial phases. Dr. Ramazani regularly publishes research and review articles in leading pharmaceutical journals and is a co-inventor on three patents on long acting injectables. He received the TRD Culture Award in 2021 and 2023, and the Innovation Award of the Year in 2016 at Novartis. In 2010, he was among the top four candidates nationally to receive a PhD scholarship from the Iranian Health Ministry. He completed his PhD in 2015 at Utrecht University in the Netherlands, focusing on polymeric micro and nanoparticles for local and targeted drug delivery.

Fatima Bennai-Sanfourche

Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer
Fatima Bennai-Sanfourche

Dr. Fatima Bennai-Sanfourche is working currently as Global Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.


Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.


She has more than 20 years of experience in the quality management, Regulatory Affairs and development of medical devices and combination products.


She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays.


In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the pharmaceuticals portfolio.
 

She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP).


She is also leading the project of the implementation of MDR for PH-Bayer AG.


She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according to the medical Device regulation.


Since July 2021 she is also a member of the European Commission Post-Market Surveillance (PMS) task force responsible for the preparation of the MDR PMS guidance according to the Article 83.
 

George Moore-Arthur

Senior Global Regulatory Professional, Novo Nordisk
George Moore-Arthur

George serves as a Senior Global Regulatory Professional at Novo Nordisk, where he leads regulatory strategy across major international markets for digital health and in vitro diagnostic (IVD) products. He holds an MSc in Biotechnology. Before his tenure at Novo Nordisk, George held various positions at the UK regulatory agency (MHRA), focusing on medicinal pharmaceutical product labelling as well as safety and surveillance for a broad range of medical devices, including surgical, wound management, and IVD devices.

Gerresheimer - Senior Representative

, Gerresheimer
Gerresheimer - Senior Representative

Haselmeier - Senior Representative

, Haselmeier GmbH
Haselmeier - Senior Representative

Jacob Moberg Sandager

Senior Circular Plastic Engineer, Novo Nordisk
Jacob Moberg Sandager

Jacob Moberg Sandager is a Senior Circular Plastics Engineer at Novo Nordisk, focusing on Device Manufacturing and Development. He applies his technical expertise to challenge the current status quo regarding the integration of recycled materials into medical devices. His innovative approach has earned him recognition, including the Circular for Zero award, for his significant work in establishing closed-loop recycling in Novo Nordisk's Medical Device production. Through these efforts, Jacob continues to drive sustainability initiatives and promote the responsible use of resources in the medical field.

Javad Jabbari

Director Regulatory Affairs RA Device and Combination Products, Ascendis Pharma
Javad Jabbari

Jussi Haikarainen

Director, Device Development , AbbVie
Jussi Haikarainen

Jussi Haikarainen, M.Sc, has worked on drug-device combination products since 1997 and currently leads Product Engineering Germany at AbbVie and acts as device technical lead roles in Combination Product-projects for both platform and asset-development. Before AbbVie Jussi worked in Device and CMC Lead roles for development and market authorisation for inhaled products at Orion Corporation, Finland. On injectables Jussi gained experience leading SoloStar insulin pen-program at Sanofi, Frankfurt 2004-2006 through development, industrialisation and regulatory approval-phases. Besides the technical aspects Jussi also has considerable DPI formulation development experience as well as regulatory experience on CTD module 3 and regulatory proceedings.

Kristine Berkenhoff

Head of Laboratory, Boehringer Ingelheim Pharma GmbH & Co. KG
Kristine Berkenhoff

• Pharmacist by education
• PhD in pharmaceutical technology on stabilization of proteins in solid form for subcutaneous administration
• Several years experience in manufacturing of parenterals
• Since 2017 primary packaging and process development of parenterals (NBEs and NCEs) at Boehringer Ingelheim with focus on Pre-filled Syringes for use in combination products
 

Louise Place

Director, Devices, Global CMC Regulatory Affairs, GSK
Louise Place

Marc Egen

Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG
Marc Egen

Marc is a polymer chemist by training and joined Boehringer Ingelheim more than 20 years ago. He was working in various positions at the interface between Development and Operations. Dealing mostly with pharmaceutical technology, manufacturing, and packaging processes, he gained experience in inhalation drug product development, solids manufacturing, launches and transfers, and solids and parenteral packaging development.

Mario Hirth

Director Global Verification Testing, AbbVie
Mario Hirth

Mario Hirth, Ph.D., leads the Global Verification and Testing Team for Devices and Combination Product Development at Development Sciences, AbbVie. Since joining AbbVie in 2013, he has held various roles in Small Molecule and Biologics Drug Product Development before transitioning to the Devices and Combination Product Development function. Dr. Hirth has been instrumental in broadening the team's scope and expertise, successfully establishing capabilities for integrated self-administration delivery systems such as Pre-filled Syringes, Auto-Injectors and On-Body-Delivery systems. In his current position, he is leading teams in the US and in Germany to drive development and verification activities for delivery systems.

 

MGS - Senior Representative

, MGS Mfg. Group, Inc
MGS - Senior Representative

Nemera - Senior Representative

, Nemera
Nemera - Senior Representative

Rachel Koppelman

Head of Device Engineering, Sandoz
Rachel Koppelman

Rachel is currently working as Head of Device Engineering for Sandoz, developing medical devices and combination products for Sandoz’s pipeline of generic and biosimilar drug products. Prior to Sandoz, Rachel headed up Bespak’s Innovation Team developing novel drug delivery devices, with a strong focus across innovation, new product development and early stage manufacturing of new injectable devices. Rachel started her career in technology consultancy, working across multiple industries and many different disciplines, including technical problem solving, IP and Human Factors. Rachel holds a Masters Degree from the University of Cambridge in Natural Sciences, Physics.
 

Richard Crowther

Sr Manager Regulatory Affairs, Amgen
Richard Crowther

Richard has experience with a variety of companies (Procter & Gamble, GSK and Merck) but has spent the last 20 years with Amgen. At Amgen, Richard has lead teams in the engineering function, supporting drug substance manufacturing and later moved into process development, supporting drug product manufacturing. With his move back to the UK, Richard joined regulatory affairs, supporting device projects in the EU.

Richard Wedge

Associate Research Fellow, Pfizer
Richard Wedge

Sandra Einemann

Customer Relationship Manager, TUV SUD Product Service GmbH
Sandra Einemann

After completing of my pharmacy degree, I worked in the pharmaceutical industry for several years. In this role, my responsibilities included developing and reviewing drug dossiers and obtaining regulatory approval for drugs and drug-device combinations before joining the medical technology (MedTech) industry. I`ve now worked at a Notified Body (TÜV SÜD) for 3 years, taking care of a key account customer and I am also responsible for Article 117 MDR services.

 

Sanofi - Senior Representative

, Sanofi
Sanofi - Senior Representative

Senior Representative

, BioPhorum
Senior Representative

Simon Wilson

Device Development Lead, Pfizer
Simon Wilson

Soren Skov

Senior Human Factors Engineer, Roche
Soren Skov

Steve Hoare

Deputy Director, Partnerships, Medicines and Healthcare products Regulatory Agency (MHRA)
Steve Hoare

Tarja Nurmi

Senior Expert, Extractables & Leachables, Bayer
Tarja Nurmi

I run the E&L Knowledge and Service Team at Bayer. We serve and support globally our project teams, working with marketed combination products and developing medical devices. My 15 years of analytical experience in the academic research group of nutritionists, epidemiologists, public health experts and medical doctors is of great benefit in understanding the chemical behavior of drug products during a long-term contact with plastic and rubber components. Since starting at Bayer over 8 years ago, I have created practical solutions in our laboratory to confirm the safety of plastic and rubber materials together with our toxicologists.

Theresa Jeary

Global Head, Medicinal & Biologics Team, BSI
Theresa Jeary

Thomas Wejs Moller

Senior RA Policy Director, Novo Nordisk
Thomas Wejs Moller

Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products.
He has extensive experience with regulating medical devices in Denmark and Europe, and he comfortably balances between business aims and regulatory demands.
As a former Director of Medical Devices in the Danish Medicines Agency and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety.
Thomas has been elected Chair of the Competent Authorities for Medical Devices (CAMD). And has experience in national and international arenas—Europe with the EU commission, EMA, Notified Bodies, Authorities, and patient organisations.
Thomas holds a master’s degree in political science from the University of Copenhagen. He has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience.

Tiffany McIntire

Device Team Leader, Roche
Tiffany McIntire

Tony Haythornthwaite

Associate Director Device Engineering, GSK
Tony Haythornthwaite

Tony Haythornthwaite is an Associate Director at GSK in the Device Engineering team. After starting a career in orthopaedic medical devices, conducting research into the wear of total knee replacements and developing implants and instruments for the foot and ankle, Tony has been working in combination product development for the last 5 years. He has worked on the development of respiratory and parenteral devices, overseeing a team of device project leads who have delivered several successful NBOps since implementation of the MDR.
 

Xavier Donnette

Device Program Lead, UCB
Xavier Donnette

Xavier Donnette is a program manager and development engineer with over 20 years of experience in the field of mechanical engineering, particularly within the medical device industry. Holding a Master’s degree in Mechanics from the prestigious École Nationale Supérieure d'Arts et Métiers (ENSAM) in France, Xavier has specialized in developing combination products and devices such as dry powder inhalers (DPI), nasal pumps, and insulin pens. His career has spanned multiple leadership roles, managing both technical and multidisciplinary teams across a variety of projects.


Xavier’s professional journey began in 2000, where he took on roles ranging from design engineer to mechanical project manager for major companies like Aptar, PSA and EADS. Over the years, his expertise in design, risk management, and compliance with industry standards has enabled him to lead complex projects from conceptualization to production, including obtaining intellectual property patents.


Currently, Xavier serves as device program lead in Switzerland for UCB, specializing in the development of Auto-injectors, On-Body Delivery Systems and other medical devices. He oversees sterility control, mechanical and electronic assessments, manages supplier relationships, and ensures adherence to standards.


In addition to his technical knowledge, Xavier is also recognized for his project management skills, having successfully led teams in international environments, including assignments in Sweden and Germany.
 

Ying Wang

Device Development Science Lead, Associate Research Fellow, Pfizer
Ying Wang

Zeon - Senior Representative

, Zeon
Zeon - Senior Representative

sponsors

Conference agenda

clock

8:00

Registration & Coffee

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8:50

Chair's Opening Remarks

Charles Potter, Project and Technical Leader, Chiesi Ltd

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9:00

Regulatory expectations for the Development and Lifecycle of Drug-Device Combination Products

Javad Jabbari

Javad Jabbari, Director Regulatory Affairs RA Device and Combination Products, Ascendis Pharma

  • Key considerations in early-stage development of pre-filled syringes and combination products, including human factors, risk management, and EDDOs
  • Strategies for aligning design control documentation with global regulatory expectations (EU MDR, NBoP, FDA, etc.)
  • clock

    9:30

    Building a Robust Device Control Strategy: From Concept to Quality Execution

    Tony Haythornthwaite, Associate Director Device Engineering, GSK

  • Approaches for establishing a harmonised framework for device critical functions addressing all development stages to ensure consistency and reliability
  • Integrating device strategy with quality by design (QbD) and leveraging QbD principles to embed quality into device development from the outset, improving risk management and regulatory readiness
  • Applying the strategy in practice: Case Study demonstrating real-world implementation of a device control strategy, highlighting lessons learned and measurable outcomes
  • Prioritising control points that impact patient safety, product performance, and regulatory compliance to drive meaningful quality assurance
  • clock

    10:00

    Session Reserved for Sponsor

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    10:30

    Morning Networking Break

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    11:00

    Industry’s focus on bespoke development for new drug delivery products delays new drugs getting to patients and increases costs

    Senior Representative

    Senior Representative, , BioPhorum

  • Improving quality documentation streamlines processes and manages information more effectively
  • Educating stakeholders and working with regulators showcases the benefits of platform approaches
  • The benefits of platform approaches can outweigh the risks and challenges
  • Greater alignment between industry and regulators means faster regulatory approval with reduced delays
  • clock

    11:30

    Session Reserved for Sponsor

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    12:00

    Fireside Chat: Keeping Up with the Evolving Drug Delivery Landscape and Looking to the Future and Beyond

  • Exploring how patients will manage their own health by the end of 2025 and its impact on drug delivery and device design, including self-injection device demand
  • Streamlining interactions and promoting effective collaboration between teams across device and drug development, and commercial stage support
  • Javad Jabbari

    Javad Jabbari, Director Regulatory Affairs RA Device and Combination Products, Ascendis Pharma

    Rachel Koppelman, Head of Device Engineering, Sandoz

    Theresa Jeary

    Theresa Jeary, Global Head, Medicinal & Biologics Team, BSI

    David Harrison, Business Lead, Drug Products and Devices, UCB

    clock

    12:30

    Networking Lunch

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    13:30

    Five Years of MDR for Combination Products: Lessons, Timelines & Industry Expectations

    Theresa Jeary

    Theresa Jeary, Global Head, Medicinal & Biologics Team, BSI

  • Insights from five and a half years of MDR implementation and adaptation
  • How evolving processes impact regulatory approval for combination products
  • An update on Notified Bodies expectations from documentation and timeline refinements
  • Industry Engagement: Timing Matters
  • clock

    14:00

    Session Reserved for Sponsor

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    14:30

    EDDO in Focus: Progress, Perspectives, and Pathways Forward

    Berengere Paris, Regulatory Affairs Specialist, RA Devices, Novo Nordisk

  • How teams are aligning design outputs with EDDO definitions to meet regulatory expectations
  • Integrating EDDOs across drug-device development to ensure consistent performance and quality
  • Strategies for harmonising specifications and controls between stakeholders
  • Anticipating international alignment and building scalable compliance frameworks
  • clock

    15:00

    Afternoon Networking Break

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    15:30

    Utilising AI in Injectable Device Development

    Fatima Bennai-Sanfourche, Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer

  • Sharing experiences on how AI is being used to optimise design, testing, report writing and decision-making across device programmes
  • clock

    15:30

    Strategic Partnerships in Injectable Drug Delivery: Aligning External Networks

    David Harrison, Business Lead, Drug Products and Devices, UCB

  • Exploring how pharma companies can build and sustain high-value partnerships with CMOs and device developers to support innovation, scalability, and performance
  • Discussing strategies for aligning to ensure mutual value creation, operational excellence, and long-term collaboration
  • clock

    15:30

    Driving Sustainability in Device Design

    Charles Potter, Project and Technical Leader, Chiesi Ltd

  • Practical strategies for reducing environmental impact across the device lifecycle—from materials to end of life
  • Key trade-offs in sustainable design, including reusability, human factors, and the integration of electronics
  • clock

    15:30

    Navigating EDDO Guidance

    Javad Jabbari

    Javad Jabbari, Director Regulatory Affairs RA Device and Combination Products, Ascendis Pharma

  • Examining the clarity and direction in EDDO guidance
  • Addressing regulatory challenges related to EDDO integration
  • clock

    17:00

    Chair’s Closing Remarks and Close of Day One

    Charles Potter, Project and Technical Leader, Chiesi Ltd

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    7:30

    Registration & Coffee

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    8:10

    Chair's Opening Remarks

    Fatima Bennai-Sanfourche, Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer

    clock

    8:20

    Integrated Combination Product Development Strategies

  • Introduction to combination product delivery systems and related development challenges
  • Streamlining combination product development by leveraging platform approaches
  • Successful combination product development by program management excellence
  • Mario Hirth, Director Global Verification Testing, AbbVie

    Jussi Haikarainen, Director, Device Development , AbbVie

    Abby Lambretti, Senior Scientist II, AbbVie

    clock

    9:00

    Collaborative Pathways to Bespoke Medical Device Innovation

    Rachel Koppelman, Head of Device Engineering, Sandoz

  • Outlining Sandoz’s approach to optimising off-the-shelf medical devices through collaboration with medical device developers
  • Aligning device functionality with drug characteristics to enhance delivery, safety, and patient experience
  • Unlocking speed, flexibility, and innovation through integrated cross-functional partnerships
  • Case studies highlighting key challenges, breakthroughs, and measurable impact from collaborative device development
  • clock

    9:30

    Session Reserved for Gold Sponsor Crux Product Design

    Crux Product Design - Senior Representative

    Crux Product Design - Senior Representative, , Crux Product Design

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    10:00

    Updates in Regulatory CMC for Injectable Combination Products

  • Aligning global expectations: FDA, EMA, and ISO convergence on device-drug interface requirements
  • Addressing sustainability in CMC: integrating recyclability, responsible material sourcing, and environmental impact into development strategy
  • Integrating human factors and usability data into CMC submissions for device-led therapies
  • Strengthening lifecycle CMC readiness: change management, post-approval variations, and digital traceability
  • Louise Place

    Louise Place, Director, Devices, Global CMC Regulatory Affairs, GSK

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    10:30

    Morning Networking Break

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    11:00

    Applying Regulatory Reliance Pathways for Drug-Device Combinations

    Andreas Emmendoerffer, Principal Regulatory Program Director, Roche

  • Overview on global harmonization efforts for drug-device combinations
  • WHO Regulatory Reliance Pathways
  • Concrete example on how these Regulatory Reliance Pathways were applied for two combination products
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    11:30

    Session Reserved for Gold Sponsor Althena Medical

    Althena Medical - Senior Representative

    Althena Medical - Senior Representative, , Althena Medical

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    12:00

    Rethinking Sustainability: Designing Meaningful Change in Injectable Drug Delivery Systems

    Conor O'Neill, Head of Packaging Development and Design, GSK

  • Sharing insights on the 'Pack of the Future' initiative, grounded in research of current industry practices and environmental impact
  • Exploring how platform designs contribute to inertia in device innovation—and where opportunities for disruption lie
  • Reviewing strategies for embedding sustainability into early-stage design and development
  • Highlighting how broader industry awareness and collaboration can accelerate meaningful change in combination product sustainability
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    12:30

    Session Reserved for Gold Sponsor MGS

    MGS - Senior Representative

    MGS - Senior Representative, , MGS Mfg. Group, Inc

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    13:00

    Advancing Sustainability from Concept to Execution in Medical Device Development

  • Practical insights and tools to equip teams with actionable guidance for integrating sustainable practices and materials into development workflows
  • Managing and reviewing trade-offs between usability, performance, cost, and environmental impact
  • Building circular business models and potential strategies for reshaping industry operations to prioritise reuse and longevity
  • Moving beyond collection and disassembly to integrating recovered materials back into production
  • Steve Hoare

    Steve Hoare, Deputy Director, Partnerships, Medicines and Healthcare products Regulatory Agency (MHRA)

    Thomas Wejs Moller, Senior RA Policy Director, Novo Nordisk

    Cedric Gysel

    Cedric Gysel, Chief Changemaker, Be Circular

    Charles Potter, Technical and Project Leader, Chiesi Ltd

    Conor O'Neill, Head of Packaging Development and Design, GSK

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    13:30

    Networking Lunch

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    14:30

    Chair's Opening Remarks

    Mario Hirth, Director Global Verification Testing, AbbVie

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    14:40

    Optimising Large Volume Injections: Formulation, Usability, and Device Functionality

    Sanofi - Senior Representative

    Sanofi - Senior Representative, , Sanofi

  • Innovations in formulation and container systems for large volume injections
  • Usability considerations for patient-centred drug delivery
  • Device functionality improvements for enhanced safety and efficiency
  • Regulatory perspectives on formulation and delivery system integration
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    15:10

    Session Reserved for Nemera

    Nemera - Senior Representative

    Nemera - Senior Representative, , Nemera

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    15:40

    Meeting Evolving Patient and Market Needs vs Regulatory Requirements

    Xavier Donnette , Device Program Lead, UCB

  • Aligning device design with patient and indication-specific needs and drawing upon this to design the right clinical studies
  • Navigating development complexities with device partners: Overcoming regulatory hurdles, technical documentation gaps, and global component shortages through early, transparent collaboration
  • Ensuring drug product compatibility, ergonomic design, and essential performance alignment while embedding sustainability and recyclability
  • Future-Proofing for Emerging Therapies: Anticipating next-generation requirements, administration routes, and volume delivery to meet the demands of diverse therapeutic pipelines
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    16:10

    Afternoon Networking Break

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    16:40

    Designing Patient-Centric Long-Acting Injectable Formulations

    Farshad Ramazani, Formulation Project Leader Senior Expert Science and Technology, Novartis Pharma AG

  • Challenges associated with long-acting injectable formulations
  • Innovations within injectable formulation focusing on volume and viscosity
  • Insight into long-acting injectable development: from small to large scale manufacture
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    17:10

    Session Reserved for Sponsor

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    17:40

    Autoinjectors for High-Volume Delivery: Integrating Human and Technical Needs

    Soren Skov

    Soren Skov, Senior Human Factors Engineer, Roche

  • The growing need for autoinjectors to accommodate larger volumes while ensuring ease of use and patient comfort
  • Balancing technical and human needs for delivery time optimization for high-volume delivery
  • Highlighting strategies to ensure usability and safety in high-volume autoinjector platforms
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    18:10

    Chair’s Closing Remarks and Closing of Day One

    Mario Hirth, Director Global Verification Testing, AbbVie

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    14:30

    Co-Chair's Opening Remarks

    Steve Hoare

    Steve Hoare, Deputy Director, Partnerships, Medicines and Healthcare products Regulatory Agency (MHRA)

    Conor O'Neill

    Conor O'Neill, Head of Packaging Development and Design, GSK

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    14:40

    Creating a Circular Loop in Healthcare: Recycling Used Prefilled Pens into New Devices

    Jacob Moberg Sandager, Senior Circular Plastic Engineer, Novo Nordisk

  • Sustainability – Environmental benefits of collecting and recycling devices
  • Collection and Sorting – ReMed: How Novo Nordisk is collecting and sorting takeback devices today
  • Quality – Ensuring product integrity with recycled materials
  • Traceability – Maintaining control over materials in production
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    15:10

    Session Reserved for Credence MedSystems

    Credence MedSystems - Senior Representative

    Credence MedSystems - Senior Representative, , Credence MedSystems, Inc.

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    15:40

    Navigating Global Compliance and Sustainability Mandates for Pharmaceuticals

    Fatima Bennai-Sanfourche, Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer

  • Understanding global compliance
  • Sustainability mandates in the pharmaceutical industry
  • Compliance challenges
  • Strategies for aligning with evolving regulations
  • Integrating sustainability into regulatory planning
  • Future outlook
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    16:10

    Afternoon Networking Break

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    16:40

    Consensus Standards to Drive Scaled Circularity for the Medical Device Industry

    Courtney Soulsby, Global Director, Healthcare and Life Sciences, BSI

  • Overall market and public perceptions on circularity of medical devices and need for trust (based on recent research with Cambridge University)
  • Standards subcommittee and links with European advisory group on medical device sustainability
  • UK Design for Life programme – role of standards and regulation
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    17:10

    Session Reserved for Haselmeier

    Haselmeier - Senior Representative

    Haselmeier - Senior Representative, , Haselmeier GmbH

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    17:40

    Circular Solutions for a Greener Future

    Cedric Gysel

    Cedric Gysel, Chief Changemaker, Be Circular

  • Strategies for embedding eco-friendly solutions in device design and manufacturing
  • Implementing closed-loop systems to minimise waste and maximise resource efficiency
  • Innovating business models for circular devices by transforming packaging and intermediate materials to extend product life cycles
  • Global expansion of circular initiatives: Lessons from Janssen’s Circular Device program and its impact on pharmaceutical sustainability
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    18:10

    Co-Chair’s Closing Remarks and Closing of Day One

    Conor O'Neill, Head of Packaging Development and Design, GSK

    Steve Hoare

    Steve Hoare, Deputy Director, Partnerships, Medicines and Healthcare products Regulatory Agency (MHRA)

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    8:00

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

    Andrew Chapman, Senior Director, AstraZeneca

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    9:00

    The Impact of Device Selection on Injectable Drug Approval

    Richard Crowther, Sr Manager Regulatory Affairs, Amgen

  • Understanding the influence of device selection on clinical and commercial approval pathways
  • Addressing regulatory complexities and timeline implications when pairing drugs with standalone delivery systems
  • Key steps for streamlined approval with practical approaches to navigating MDR requirements and minimising delays in clinical trials
  • Recommendations on reducing regulatory burdens and improving efficiency in injectable device development
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    9:30

    Risk Management: Between – and even within – companies, common hazards and harms can be scored in different ways, leading to confusion, questions and delays to new drug approvals

    Richard Wedge

    Richard Wedge, Associate Research Fellow, Pfizer

  • Developing a library of common hazards and harms will help to streamline (harmonize) ratings across sponsors, CDMOs, suppliers
  • Submissions will be ‘de-risked’ – with more consistent and predictable results
  • Applying common approaches to common, drug-agnostic hazards and harms showcases an industry that is coordinated and consistent, and willing to work together
  • Aligning with suppliers further demonstrates the end-to-end value in reducing redundancies, building efficiencies, and getting valuable medicines to patients
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    10:00

    Session Reserved for Gold Sponsor

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    10:30

    Morning Networking Break

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    11:00

    Clinical Evaluation Plans and Reports: Breaking Silos and Building Bridges

    Tiffany McIntire

    Tiffany McIntire, Device Team Leader, Roche

  • Overview of the CEP and CER requirements
  • Connecting ISO14971 requirements with the CEP and CER
  • Harmonizing processes across Clinical and Device
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    11:30

    Article 117 in Practice: Optimising Submissions for Drug-Device Combination Products

  • Best practices and recommendations on how to prepare compliant documentation
  • Reviewing common pitfalls in Article 117 submissions and how to avoid delays in the review process
  • Clarifying expectations for General Safety and Performance Requirements (GSPRs) and how they align with the device’s intended use in the DDC
  • Practical strategies to streamline collaboration between pharma and device developers for faster, more predictable approvals
  • Anja Hartmann, Lead Auditor / Product Specialist, TUV SUD Product Service GmbH

    Sandra Einemann, Customer Relationship Manager, TUV SUD Product Service GmbH

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    12:00

    Harnessing AI to Accelerate Combination Product Development: From Submission to Clinic

    Ying Wang

    Ying Wang, Device Development Science Lead, Associate Research Fellow, Pfizer

  • Leveraging AI in design controls and GMP workflows
  • Using predictive modelling to simulate device performance and drug delivery outcomes
  • Exploring AI-driven bioavailability forecasting and virtual patient modelling
  • Enabling in silico clinical trials to streamline regulatory submissions and reduce timelines
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    12:30

    Panel Discussion: Optimising Drug-Device Combination Product Development with AI

  • Leveraging AI to streamline and speed up drug-device combination product development
  • Securing and integrating AI: strategies for safely incorporating AI technologies into healthcare systems
  • Measures for ensuring patient safety and ethical AI application
  • Future outlook: Predictions on AI-driven advancements and regulatory trends in drug-device development
  • Fatima Bennai-Sanfourche, Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth, Bayer

    Andrew Chapman, Senior Director, AstraZeneca

    Ying Wang

    Ying Wang, Device Development Science Lead, Associate Research Fellow, Pfizer

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    13:00

    Networking Lunch

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    14:00

    Chair's Opening Remarks

    Marc Egen, Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG

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    14:10

    Air Transport Simulation Study of Pre-Filled Syringes

    Kristine Berkenhoff, Head of Laboratory, Boehringer Ingelheim Pharma GmbH & Co. KG

  • Definition of sterility barrier of container closure systems
  • Methods to assess plunger stopper movement under vacuum conditions
  • Case study: air transport simulation of PFS
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    14:40

    Session Reserved for Zeon

    Zeon - Senior Representative

    Zeon - Senior Representative, , Zeon

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    15:10

    Strategic Pathways for Combination Products in a Shifting Regulatory Landscape

    Berna Kosekaya

    Berna Kosekaya, Regulatory Professional, RA CMC & Devices/RA Device, Novo Nordisk

  • Global regulatory updates on combination products
  • Understanding combination products in EU: definitions and frameworks
  • Challenges and strategic pathways for regulatory professionals
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    15:40

    Afternoon Networking Break

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    16:10

    Maximising Safety and Efficiency in E/L Strategy

    Tarja Nurmi, Senior Expert, Extractables & Leachables, Bayer

  • Designing robust Extractables and Leachables studies that meet regulatory expectations while supporting platform device strategies
  • Understanding how product-specific characteristics influence the analytical evaluation threshold and guide risk-based decision-making
  • Reviewing study results and exposure calculations to ensure accurate, product-relevant safety assessments
  • Translating toxicological evaluations data into actionable insights that support safe, efficient product approvals
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    16:40

    Session Reserved for Sponsor

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    17:10

    ISO 10993-1:2025 — Identified Challenges and Impact on New and Legacy Combination Products

    BioPhorum - Senior Representative

    BioPhorum - Senior Representative, , BioPhorum

  • The impact of the standard on legacy combination products
  • Changes in categorization and what it means for combination products
  • How to navigate the integration of ISO 14971 principles
  • Overall impact of the standard – the good, the bad, and the ugly
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    17:40

    Chair’s Closing Remarks and Closing of Day Two

    Marc Egen, Head of Primary Packaging & Process Development, Boehringer Ingelheim Pharma Gmbh & Co. KG

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    14:00

    Chair’s Opening Remarks

    Simon Wilson

    Simon Wilson, Device Development Lead, Pfizer

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    14:10

    Designing Connected Devices That Patients Actually Want

    Simon Wilson

    Simon Wilson, Device Development Lead, Pfizer

  • Highlighting how the pharmaceutical industry must evolve to meet patient expectations in a digitally connected world
  • Demonstrating the value of co-creating with patients to design experiences that drive adherence, satisfaction, and trust
  • Exploring what makes a connected experience truly great—beyond just building an app
  • Offering a fresh perspective on product design, drawing unexpected inspiration from other industries
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    14:40

    Session Reserved for Gerresheimer

    Gerresheimer - Senior Representative

    Gerresheimer - Senior Representative, , Gerresheimer

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    15:10

    Personalised Health in Practice: Digital Innovation in Injectable Drug Delivery

    George Moore-Arthur, Senior Global Regulatory Professional, Novo Nordisk

  • Examining developments in the use of digital technologies in optimising injectable therapies through personalised, data-driven treatment approaches
  • Discussing strategies for navigating global regulatory submissions for digital health-enabled medical devices, with a focus on compliance and market access
  • Highlighting case studies showcasing successful integration of digital ecosystems across the injectable device lifecycle
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    15:40

    Afternoon Networking Break

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    16:10

    Connected Autoinjector Development: Empowering Patients and Driving Better Clinical Outcomes

    Senior Representative

    Senior Representative, , To be confirmed

  • Key challenges and pitfalls encountered during development and key takeaways for future development
  • Purpose-driven connectivity: How to determine when connectivity adds real value, and when it doesn’t—anchored in measurable patient outcomes
  • Ensuring digital features enhance adherence, engagement, and clinical results without overcomplicating the user experience
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    16:40

    Session Reserved for DCA Design

    DCA - Senior Representative

    DCA - Senior Representative, , DCA

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    17:10

    Stream Closing Panel: Connecting the Dots – Unlocking the Full Potential of Digital Tools in Injectable Platforms

  • Reflecting on key themes from the stream—ranging from device connectivity to data-driven user support—and how they collectively shape the future of patient experience
  • Challenges and opportunities in aligning digital tools across platforms, ecosystems, and stakeholders for seamless user journeys
  • Exploring emerging trends, unmet needs, and collaborative pathways to accelerate development in the field
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    17:40

    Chair’s Closing Remarks and Closing of Day Two

    Simon Wilson

    Simon Wilson, Device Development Lead, Pfizer


    Senior Scientist II
    AbbVie
    Althena Medical
    Principal Regulatory Program Director
    Roche
    Senior Director
    AstraZeneca
    Lead Auditor / Product Specialist
    TUV SUD Product Service GmbH
    Regulatory Affairs Specialist, RA Devices
    Novo Nordisk
    Regulatory Professional, RA CMC & Devices/RA Device
    Novo Nordisk
    BioPhorum
    Chief Changemaker
    Be Circular
    Project and Technical Leader
    Chiesi Ltd
    Head of Packaging Development and Design
    GSK
    Global Director, Healthcare and Life Sciences
    BSI
    Credence MedSystems, Inc.
    Crux Product Design
    Business Lead, Drug Products and Devices
    UCB
    Formulation Project Leader Senior Expert Science and Technology
    Novartis Pharma AG
    Global Senior Director for QA & RA Compliance, Medical Devices, Combination Products & eHealth
    Bayer
    Senior Global Regulatory Professional
    Novo Nordisk
    Gerresheimer
    Haselmeier GmbH
    Senior Circular Plastic Engineer
    Novo Nordisk
    Director Regulatory Affairs RA Device and Combination Products
    Ascendis Pharma
    Director, Device Development
    AbbVie
    Head of Laboratory
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Director, Devices, Global CMC Regulatory Affairs
    GSK
    Head of Primary Packaging & Process Development
    Boehringer Ingelheim Pharma Gmbh & Co. KG
    Director Global Verification Testing
    AbbVie
    MGS Mfg. Group, Inc
    Head of Device Engineering
    Sandoz
    Sr Manager Regulatory Affairs
    Amgen
    Associate Research Fellow
    Pfizer
    Customer Relationship Manager
    TUV SUD Product Service GmbH
    BioPhorum
    Device Development Lead
    Pfizer
    Senior Human Factors Engineer
    Roche
    Deputy Director, Partnerships
    Medicines and Healthcare products Regulatory Agency (MHRA)
    Senior Expert, Extractables & Leachables
    Bayer
    Global Head, Medicinal & Biologics Team
    BSI
    Senior RA Policy Director
    Novo Nordisk
    Device Team Leader
    Roche
    Associate Director Device Engineering
    GSK
    Device Program Lead
    UCB
    Device Development Science Lead, Associate Research Fellow
    Pfizer

    Gold Sponsors

    Sponsors

    Exhibitors

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    Advisory Board Letter

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    Past Speaker Interview - Michael Kuehler

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    Sponsors and Exhibitors


    Althena Medical

    Gold Sponsors
    http://www.althenamedica.it/

    Althena Medical is an Italian company specialized in the development and production of medical devices in the pharmaceutical field (pre-fillable syringes, oral liquid dispensers, droppers, etc.). In our catalogue we currently have COP pre-fillable syringes in several volumes. We also offer filling service and turn-key products.

    We work for small, medium and big brands for which we have designed, created and produced patented products.

    We differ from our competitors because we are flexible, reliable and we develop medical devices on demand very quickly.

    100% Made in Italy!



    Crux

    Gold Sponsors
    https://www.cruxproductdesign.com/

    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom and Cambridge, Massachusetts, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems.



    MGS

    Gold Sponsors
    http://mgsmfg.com

    A global provider of healthcare contract development and manufacturing solutions, MGS provides the right balance to drive vital innovations: robust, vertically integrated global capabilities combined with the strong customer focus and seamless collaboration of an agile partner. That’s why we’re the healthcare CDMO of choice for today’s leading Pharma, Diagnostic and MedTech companies.


    Sponsors


    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    DCA

    Sponsors
    https://www.dca-design.com/

    DCA offer comprehensive design, development and analysis solutions for the medical devices industry.

    Our multidisciplinary team offers an integrated, evidence based service focused on helping our clients achieve success through great product design.

    With a wealth of experience in developing leading injection devices for global markets, DCA’s work includes: variable dose pen injectors, single and multi-fixed dose injectors, disposable and reusable products, autoinjectors, wearable patch injectors, large volume injectors, connected and electro-mechanical devices.

    Our portfolio encompasses mass-market injectors that are manufactured in multi-billions, as well as lower volume devices targeting specific user populations and regional market needs. Alongside device design, we provide comprehensive support for industrialisation/production and create innovative instructions and product packaging solutions.

    Since 2000 our team have created over 1,700 granted patents for our clients. In the last 10 years we have received over 100 major design awards and supported our clients to launch more than 100 new products. We can provide expert support for device strategy, usability, due diligence, connectivity, mechanical engineering, electronics, medical device software, industrial design, UX/UI development, prototyping, industrialisation/production support, packaging and instruction design. We are certified to ISO13485 and work to ISO14971, IEC62304 and IEC62366.



    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical primary packaging, drug delivery systems and digital solutions. Gerresheimer ensures that medicines reach patients safely and can be administered reliably. With around 12,000 employees and 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets with a focus on the pharma industry.



    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.



    Owen Mumford

    Sponsors
    http://www.ompharmaservices.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.

    Exhibitors


    Harro Höfliger

    Exhibitors
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.

    The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production.



    Kern Liebers

    Exhibitors
    https://www.kern-liebers.com/en

    KERN LIEBERS, a medium-sized family company based in southwest Germany, is a global technology leader for the engineering and production of highly complex metal components and hybrid assemblies at over 40 locations around the world. Specialized in tailor made SMART SPRINGS and SMART PARTS for specific drug delivery systems.

    SMART SPRINGS - Customized Intelligent Power Packs Design elements as trigger mechanism for drug administration and energy storage in drug delivery systems. Global manufacturer and engineering partner of wire springs, wave springs and flat springs.

    SMART PARTS – Customized, Highly Complex Components Design elements for all kind of safety-relevant functions. Global manufacturer and engineering partner of stamped-bent parts, micro-stamped components, assemblies and laser welded parts.

    Billions of safety-relevant metal components have been manufactured since the 19th century at KERN LIEBERS. The function of these structural elements ensures the highest level of protection for human life with an upward trend. There are many parallels of safety-relevant parts with regard to highest requirement of reliability and an absolute mode of functionability in all industries, especially in the medical industry. KERN LIEBERS proves this time and again through perfectly customized engineering solutions together with the customer, manufacturing expertise and an awareness of individual, visionary solutions.



    Kymanox

    Exhibitors
    https://www.kymanox.com/

    Kymanox® is your life science solutions partner with a diverse team of experts who know how to connect the dots and make sure you have the right end-to-end solutions for your modern medicine development & commercialization challenges.

    We are experts in providing our clients in the combination products, biologics, pharmaceutical, and medical device industries with support from early development to post-market. We help bring products from bench to patient.



    SHL Medical

    Exhibitors
    http://www.shl-medical.com

    SHL Medical is a pioneering leader in self-injection solutions, such as autoinjectors. Driven by our purpose of “enabling patients’ independence”, we partner with leading pharma and biotech companies to develop self-injection systems and digital solutions that enhance patients’ treatment experience and quality of life. Our customers benefit from our proven track record and scalable, global manufacturing excellence, with locations in Switzerland, USA, Sweden, and Taiwan. By focusing on innovation, we challenge the status quo and shape the future of state-of-the-art drug delivery. We cover the entire drug delivery value chain, providing piece of mind through our end-to-end services, from design, development, to final assembly, labeling, and packaging.


    Smithers

    Exhibitors
    https://www.smithers.com/en-gb/home

    Smithers Medical Device Testing supports medical device and pharmaceutical manufacturers in bringing innovative, compliant, and high-performing products to market through expert, independent testing services. Operating from accredited laboratories in the USA, UK, and Europe, Smithers offers a comprehensive range of services including extractables and leachables (E&L) studies, functional testing for medical and combination devices, packaging validation, and advanced materials testing. With deep technical expertise and a commitment to the highest quality standards, Smithers partners with clients at every stage of the product lifecycle—from early R&D through regulatory submission and beyond—to ensure performance, efficacy, and global market readiness.



    Stevanato

    Exhibitors
    https://www.stevanatogroup.com/en/

    Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes, and services that address customer needs across the entire drug life cycle at each of the development, clinical, and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation, and its engineering excellence are central to its ability to offer value-added solutions to clients. To learn more, visit: www.stevanatogroup.com


    teamtechnik

    Exhibitors
    https://www.teamtechnik.com/en/medtech

    At teamtechnik, we have been living automation since 1976. As part of the Dürr Group, we are specialists in assembly and functional test systems. Globally, with more than 1,100 Employees, teamtechnik develops sophisticated production systems for high-tech products in the fields of e-mobility, medical technology and new energy. Our slogan… WE LIVE AUTOMATION.

    Our customers have to manufacture sophisticated injection products in large quantities. This requires highly accurate assembly and functional test processes. teamtechnik has developed a unique expertise in this area and provides reliable assembly solutions for pre-assembly, final assembly and function testing - the complete production chain from a single source.



    Terumo

    Exhibitors
    https://www.terumopharmaceuticalsolutions.com/en-EMEA

    As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

    Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.

    We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.

    Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.

    We listen. We question. We deliver.



    UPG International

    Exhibitors
    http://www.upgintl.com/market/healthcare/

    UPG International is a global CMO of precision medical devices and components. It has facilities in the UK, US, Mexico and China with precision plastics injection moulding, precision metal machining, ISO Class 7 cleanroom, electronics integration, assembly, logistics capabilities. We focus on drug delivery devices, IVD consumables, surgical arterial stent delivery and other instruments. We can assist with new product development as well handling existing high-volume product manufacture.


    Media Partners


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    ONdrugDelivery

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides readers throughout global pharma/biopharma with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: ondrugdelivery.com/subscribe


    pharmaphorum

    Official Media Partner
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    The Medicine Maker

    Official Media Partner
    https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

    The Medicine Maker is a print and digital publication as well as a weekly newsletter. At The Medicine Maker, we bring people into the limelight, showcasing the industry’s success stories and examining its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward. Register for your FREE print or digital magazine or subscribe to our newsletter here! https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo


    Drug Development and Delivery

    Official Media Partner
    http://drug-dev.com/

    Drug Development & Delivery, including its exclusive Specialty Pharma section, is a print publication, conference organizer (Drug Development Networking Summit), and online content provider exclusively committed to advancing the applied science, technology, and related business practices of pharmaceutical and biological drug development, reporting on formulation design, bioavailability and solubility enhancement, drug delivery and platform technologies, life cycle management, compound-enabling strategies, business development, outsourcing services, and partnerships and collaborations. Through insightful scientific, business, news, and technology-related formats, Drug Development & Delivery provides pharmaceutical professionals with practical solutions to the issues, opportunities, and challenges in the ever-evolving drug development communities. We complement your business development initiatives, connecting you with and influencing the audiences that matter most to you: investors, business partners, technology and service seekers, and regulatory agencies.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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