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Pre Filled Syringes East Coast
April 24 - April 25, 2023
Pre Filled Syringes East Coast

SAE Media Group’s 10th Annual Conference
Pre-Filled Syringes East Coast
April 24- 25, 2023 | Boston, USA
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The 10th annual Pre-Filled Syringes East Coast conference will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the pre-filled syringes industry, helping attendees to secure global success for their devices.

The past year has seen significant developments in the injectables landscape with the evolving regulatory landscape, accelerating opportunities in digitilization and simulation to improve device design efficiency, and increased opportunities for connectivity to improve the user experience.


Furthermore, with a growing need for circular economy, this year’s conference will assess case studies of sustainable approaches for device packaging and life cycle management, while panel discussions, FDA and BioPhorum addresses will evaluate current and upcoming combination product guidelines and the potential for harmonization.

As part of SAE Media Group’s leading drug delivery portfolio of events, this event will bring you the key insights you need to expand and enhance your injectable device portfolio and the opportunity to network with senior players throughout the industry.


We hope to welcome you to this must attend event in April 2023.
 

FEATURED SPEAKERS

Alie Jahangir

Alie Jahangir

Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
Andrew Susott

Andrew Susott

Director of Human Factors / User Experience, Global Device & Packaging Development, Novartis
Christian Liebl

Christian Liebl

Senior Innovations and Process Manager, Schreiner MediPharm
Deep S Bhattacharya

Deep S Bhattacharya

Senior Scientist Formulation and Process, Development- Biotherapeutics, Pfizer
Edwin Lyons

Edwin Lyons

Associate Director – Head of Medical Devices, CSL Behring
Ellie Younger

Ellie Younger

Head of Sustaining Engineering, Biogen
Eric Houde

Eric Houde

Senior Manager Combination Products, Regeneron
Hiroki  Hasegawa

Hiroki Hasegawa

Researcher, Mitsubishi Gas Chemical Company, Inc
James Leamon

James Leamon

Director Device Development, Device Development
John Barr Weiner

John Barr Weiner

Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
John Merhige

John Merhige

Chief Commercial Officer, Credence MedSystems
John Schalago

John Schalago

Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
Joyce Zhao

Joyce Zhao

Director, Combination Product, Takeda
Katja Klenner

Katja Klenner

Sr Engineer III, Biogen International GmbH
Kirk Roffi

Kirk Roffi

Senior Scientist, Pfizer
Konrad Betzler

Konrad Betzler

Vice President Quality, Haselmeier
Larry Atupem

Larry Atupem

Strategic Business Development Manager, Zeon Specialty Materials
Lauren Ziegler

Lauren Ziegler

Senior Director Medical Devices, Novartis
Laurent Dionet

Laurent Dionet

Head of Packaging Development , Biogen International GmbH
Ludovic Gil

Ludovic Gil

R&D Senior Engineer - Product Engineering, BD Medical - Pharmaceutical Systems
Lynne Liao

Lynne Liao

Sr. Engineer, Device Development, Alexion Pharmaceuticals
Matthew  Ondeck

Matthew Ondeck

Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals
Ning Yu

Ning Yu

Director, Product and Technology Development, Biogen
Scott Nunn

Scott Nunn

Director, Device Development, Gilead Sciences, Inc
Shruti Parikh

Shruti Parikh

Associate Director Product Development, Takeda Pharmaceuticals
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Tony Wasilewski

Tony Wasilewski

Vice President, Pharmaceutical Development Services, Apiject

Alie Jahangir

Sr. Principal Engineer, Product Quality Management, Johnson & Johnson
Alie Jahangir

Dr. Jahangir is an innovative, and cross functional team leader at Janssen Pharmaceutical in charge of E2E development and execution of Quality Management Systems for complex Biologic-Device Combination Products. He has championed the development and global launch of several safe, effective and functional combination products. With a unique multidisciplinary technical background along with 15 years of experience in Quality, R&D, and Regulatory Affair, Alie’s passion lies in enablement of new emerging technologies into practical solutions with direct impact on patients’ therapeutic journey and their well-being. He is currently engaged in integrating emerging digital and advanced devices modalities, with bold mission to revamp the Pharma’s existing quality infrastructure that utilizes more digital and data analytic capabilities to address patients’ unmet needs, more efficiently. Prior to Janssen, He has led a successful R&D career, managing, developing, and commercializing advanced polymeric technologies in consumer, oil & gas, and medical devices industries. Dr. Jahangir is also an Adjunct Professor at the Department of Bioengineering at Temple University in Philadelphia. He holds a Doctorate and Master’s degree in Polymer & Biomedical Engineering from University of Toronto and Dalhousie University and completed a Post-Doctoral Fellowship at Harvard School of Public Health in Boston.

Andrew Susott

Director of Human Factors / User Experience, Global Device & Packaging Development, Novartis
Andrew Susott

Andrew Susott is the Director of Human Factors and User Experience at Novartis Pharmaceuticals. Andrew has a passion for leading people in the development of patient centric medical devices. With over 20 years experience in the medical device/pharmaceutical industry, Andrew has led multiple teams to successfully launch multiple products globally.
Andrew holds a BA of Mechanical Engineering from Purdue University and has previously worked for Ethicon Johnson & Johnson in various functions including manufacturing, quality assurance, quality engineering and project management. He is a servant leader who is passionate about the patient’s experience and developing associates.
Andrew enjoys spending time and traveling with his wife and two daughters. In his spare time he likes playing sports, coaching his daughter’s soccer team and working on home improvement projects.

Christian Liebl

Senior Innovations and Process Manager, Schreiner MediPharm
Christian Liebl

Christian Liebl started 2009 at Schreiner MediPharm's global headquarters in Munich/Germany as a Product Manager.
In 2011 he relocated to their new US facilities in Blauvelt, NY, to establish the US Product Management and Development Department.
In 2018 Christian changed into Schreiner's Innovations and Business Development group. As Senior Innovations and Process Manager, he is working closely with key customers to solve unique challenges and to identify their future needs.
He is also on the Board of Directors at Rx-360. This international consortium addresses pharmaceutical and medical device supply chain security in relation to public health concerns and patient safety.

Deep S Bhattacharya

Senior Scientist Formulation and Process, Development- Biotherapeutics, Pfizer
Deep S Bhattacharya

Deep S Bhattacharya is a senior scientist working with DPDD since November 2019. He received his Ph.D. 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 characterizations in multiple animal models. After joining Pfizer, he has worked with DMD gene therapy, CD80, p40-TL1A bispecific, and currently leading CpG/Alhydrogel adjuvant program for C.Diff and Tetra-Fab LTβR programs. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilizing 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 understanding business strategies for developments of biopharmaceuticals. He also is involved group functions involving CPED DPDD and new colleague recruitments efforts with the St. Louis DPDD.

Edwin Lyons

Associate Director – Head of Medical Devices, CSL Behring
Edwin Lyons

Edwin is the head of delivery system development in the ‘Primary Packaging and Medical Device’ group in CSL Behring. Edwin has over 20 years experience in the design and development of drug-device combination products and a diverse range of medical devices. Edwin has a M.Eng.Sc in Biomedical Engineering from the University of Galway, Ireland and an M.B.A from Loughborough University, UK. Edwin is an active member of the BioPhorum ‘Essential Performance Requirements (EPR)’ workstream that is a cross-industry collaboration to consider the interpretation, identification, and control of EPRs for drug delivery systems.

Ellie Younger

Head of Sustaining Engineering, Biogen
Ellie Younger

Ellie Younger (she/her) has worked in a variety of medical device areas as a development lead for 18 years, but always with an eye towards usability and science based decision making techniques. Ellie has a degree in Master of Human Factors Engineering from Wright State University and a Master’s of Engineering Management from Tufts. She is currently a medical device project lead with Biogen supporting both drug delivery and digital health initiatives. In her spare time, she volunteers as an organizer with Arisia (pron. ah REE sha), a local science fiction convention.

Eric Houde

Senior Manager Combination Products, Regeneron
Eric Houde

Eric is a Senior Manager in Combination Products development group at Regeneron. Eric has over 20 years of experience in medical device and combination products development. Eric has held roles in R&D device development, Project Management, Quality Systems, and process implementation engineering. Eric has successfully developed and commercialized many products from product inception all the way to full commercial scale up. Additionally, he has successfully rolled out large organizational initiatives and large complex products that required cross collaboration to meet company objectives effectively and efficiently.

Hiroki Hasegawa

Researcher, Mitsubishi Gas Chemical Company, Inc
Hiroki  Hasegawa

Mr. Hiroki Hasegawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2013 and a Master Degree of Science in 2015 from Osaka University.
Since April 2015 he has been working for Mitsubishi Gas Chemical Company, Inc. and in charge of macromolecular science, especially in composition development of thermosetting resin.
Since 2018 he has joined a development team of multilayer plastic vial & syringe for biologics.

James Leamon

Director Device Development, Device Development
James Leamon

Jim is a medical device and drug device combination product development leader, an engineering director, and a manufacturing manager. He is experienced in working across functions and business groups in varying organizations. Jim has successfully brought new and effective products to market throughout the world and has developed and implemented new engineering, quality control and manufacturing processes. Jim has led product development, and contract engineering teams. He is highly experienced and proficient in CMC drug-device combination product leadership as well as strategic planning, design engineering, manufacturing engineering and new product and process development.

Jim is also a community leader in social justice and feeding the hungry. As treasurer of a non-profit organization, he has used his strategic planning and financial management skills to help people in need. This correlates well with his career drive to improve the lives of cancer patients and those with other life threatening diseases.
 

John Barr Weiner

Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
John Barr Weiner

John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a B.A. from Princeton University and a J.D. with honors from the Columbia University School of Law.

John Merhige

Chief Commercial Officer, Credence MedSystems
John Merhige

John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi. He came to Sanofi upon its acquisition of Pluromed, which John joined in its early stages and where he was a member of the executive management team leading the Company’s sales and marketing efforts. Prior to Pluromed, John founded Prelude Devices to target early-stage medical device technologies for development and commercialization.

John Schalago

Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
John Schalago

John is Regulatory/Quality/Clinical professional with over 30 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. John has extensive experience with global health authorities as well as with CDRH, CBER, and CDER managing submission strategies, HA interactions and submissions. John has a diverse background which includes expertise in combination products, software-controlled medical device submissions including, sensors (implantable, minimally invasive and in-vitro diagnostics, and software as a medical device, including, mobile applications and web-based clinical decision software.

Joyce Zhao

Director, Combination Product, Takeda
Joyce Zhao

Dr. Zhao has more than 10 year experience on medical device development including combination product device such as Autoinjector, Wearable/Patch injector, Pen Injector, Prefill Syringe (PFS), as well as needle technology, and other drug delivery devices. Currently Dr. Zhao is the Associate Director of Combination Product Development at Takeda Pharmaceuticals, prior to Takeda, Dr. Zhao was an Associate Director at Dr. Reddy’s Laboratories responsible for all device development activities. Prior to Dr. Reddy’s, Dr. Zhao has been with Becton Dickinson and Company (BD) at Franklin Lakes, NJ USA for 9 years. Her work at BD was focused on drug delivery systems. She was the technical lead and project leader at R&D for various device development projects and has hands on experience on device concept, design, characterization, analysis and manufacturing.
Dr. Zhao holds a Ph.D in mechanical engineering from University of Washington, Seattle, WA USA.
 

Katja Klenner

Sr Engineer III, Biogen International GmbH
Katja Klenner

Katja Klenner works as Senior Engineer III in the Global Packaging Development team at Biogen, based in Baar (CH). After completing studies in packaging engineering at the Berlin University of Applied Sciences, she held several positions in the cosmetics industry focusing on customer-centric and cost-effective packaging solutions for almost 20 years. Taking a fresh start in her career, Katja joined Biogen 3 years ago and has since taken on responsibility for several packaging development projects, both for new projects and life cycle projects for biologics. and combination products.

Kirk Roffi

Senior Scientist, Pfizer
Kirk Roffi

As a senior scientist at Pfizer, Kirk contributes to packaging and process development for injectable biologics. Kirk's background is in Chemical Engineering and he is currently a graduate student at the University of Massachusetts Lowell. Recent scientific interests include modelling of drug delivery systems and process equipment.

Konrad Betzler

Vice President Quality, Haselmeier
Konrad Betzler
  • Graduated in Pharmacy from the University Tübingen
  • More than 20 years leadership experience in Quality Management within the Pharmaceutical and Medical Device Industry and Pharmaceutical Distribution, i.a. at Catalent and McKesson
  • VP Quality with overall responsibility over Quality Management, Quality Assurance, Regulatory and Risk Management at Haselmeier
  • As Qualified Person involved in releasing Investigational Medicinal Products and Combination Products

Larry Atupem

Strategic Business Development Manager, Zeon Specialty Materials
Larry Atupem

Larry Atupem is the Business Development Manager at Zeon Specialty materials with responsibility of Cyclic Olefin Polymer business in North America. He also assists with ZEON’s strategic interests in the region looking for new opportunities in the diagnostic space. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a B.S. in Chemical & Biological Engineering from Tufts University and MBA from Boston University.

Lauren Ziegler

Senior Director Medical Devices, Novartis
Lauren Ziegler

Lauren Ziegler is Senior Director, Medical Devices, leading strategic projects in Regulatory Affairs at Novartis. During the past 7 years at Novartis, she has experience working on Combination Products, novel drug delivery devices and Software as a Medical Device (SaMD), including digital therapeutics and AI/ML-based clinical decision support software. She has a B.S.M.E. degree in Mechanical Engineering and an M.B.A in Pharmaceutical Marketing and has over 20 years of industry experience.

Laurent Dionet

Head of Packaging Development , Biogen International GmbH
Laurent Dionet

Laurent Dionet leads the Global Packaging Development team at Biogen based in Baar (CH). He started his career as a formulation chemist at DuPont in the Agro-pharmaceutical sector. The interaction of drug products with plastic packaging and their environmental impact interested him early on and inspired him to join packaging development. He gained broad experience in different positions in different companies (Dow-Agrosciences, Novartis and Roche). 3 years ago, Laurent joined Biogen where he initiated packaging projects with a focus on innovation and sustainability. He is also part of Biogen’s Initiative “Healthy Climate, Healthy Life®”. His motto: Develop for the benefit of the Patient and the Environment.

Ludovic Gil

R&D Senior Engineer - Product Engineering, BD Medical - Pharmaceutical Systems
Ludovic Gil

Ludovic Gil currently works as a Senior R&D Engineer in BD Medical - Pharmaceutical Systems on Pre-Filled Systems, based in Le Pont-de-Claix, France.
His main areas of research are the following:
- Continuum modeling of parenteral drug administration
- Multiphysics couplings in solids and poromechanics
- Deep-cold storage of medical devices
His education:
- PhD in “Mechanics of fluids and solids, acoustics” from the “Institut Polytechnique de Paris” (Ecole Polytechnique), Palaiseau, France
- Master of Science degree in Space Engineering from the California Institute of Technology, Pasadena CA, USA
- French engineer degree (focus on Mechanical Engineering) from the Ecole Polytechnique, Palaiseau, France
 

Lynne Liao

Sr. Engineer, Device Development, Alexion Pharmaceuticals
Lynne Liao

Lynne Liao is a Sr. Engineer in Device Development at Alexion, AstraZeneca Rare Disease Unit. She is responsible for characterizing drug delivery devices and combination products from early stage technology selection to product development and commercialization. She has 6 years of R&D and Product Development experience in the medical device industry with the focus on test method development, device characterization and process development.

Matthew Ondeck

Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals
Matthew  Ondeck

Matthew is a Senior Manager of Regulatory Affairs at Regeneron Pharmaceuticals in the Combination Product Regulatory Affairs Department and handles portfolio development for oncology, general medicine, infection disease, and hematology programs within the company. Prior to joining Regeneron, Matthew was a Team Lead and Reviewer within FDA/CDRH for 5 years, specializing in combination products and drug delivery systems. He also has contributed to several international technical standards defining testing requirements for drug delivery systems.

Ning Yu

Director, Product and Technology Development, Biogen
Ning Yu

Ning Yu is Director, Product and Technology at Biogen, leading the device design and development team. Ning has been working in the field of drug delivery device for the past twelve years, with broad experience on syringes, auto injectors, pen injectors, needle safety, wearable pumps, IV kit, and monitoring devices. Ning has worked on combination products from both the medical device and biopharma sides. Prior to entering the drug delivery device world, Ning worked on orthopedic implants and computer hard drives. Ning has a BS in Mechanical and Electrical Engineering, MS and PhD in Mechanical Engineering from University of Illinois at Urbana-Champaign. Ning is currently a member of the ISO/TC 84 working groups.

Scott Nunn

Director, Device Development, Gilead Sciences, Inc
Scott Nunn

Scott Nunn is responsible for Device Engineering at Gilead Sciences in Foster City, CA. Scott is passionate about developing products to improve patient’s lives. Gilead’s combination product portfolio includes both development and commercial combination products developed to treat grievous illnesses.

Scott has been working in the pharmaceutical industry for 16 years and has experience in development of various parenteral drug delivery devices. In his free time, Scott enjoys spending time with his family, working on home renovation projects and spending time outdoors.

Shruti Parikh

Associate Director Product Development, Takeda Pharmaceuticals
Shruti Parikh

Shruti Parikh is the Packaging Design Lead, Takeda Pharmaceuticals based out of Massachusetts, USA, where she is leading and building Industrial Design, Sustainable Design and Patient-Centric Design capabilities across the company.
As the design lead in packaging development Shruti and her team works towards the remit to integrate design across the company’s consumer, medical device, and pharmaceuticals sectors. In addition to helping improve the lives of the patients using Takeda products every day, the Design team is also focused on improving the environmental impact by reducing the carbon footprint of Takeda packaging.
Specifically, Shruti is passionate about challenging people and organizations to think differently. She loves to dig into global macro trends and translate its potential to redesign products and systems. Impatient for action, she wants to help build an inclusive future that allows us all to thrive socially, ecologically and economically. She is an advocate for a circular economy and is constantly looking to connect with individuals who believe they too can make a positive impact in the world.

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Theresa Scheuble

Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.
Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.

Tony Wasilewski

Vice President, Pharmaceutical Development Services, Apiject
Tony Wasilewski

Tony is the Vice President of Pharmaceutical Development Services at ApiJect. Spanning 25 years of expertise in the pharmaceutical industry, Tony has spent much of his career focused on the development and launch of generic injectables. Prior to joining ApiJect, he was Vice President of Program Management & Business Development at Fresenius Kabi. Tony held positions in a range of functional areas in his career, including 503B outsourcing, new product development, aseptic manufacturing, and R&D. Tony holds a M.S. in Product Design and Development from Northwestern University and a Bachelor of Science in Chemistry from Northern Illinois University.

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Chairman's Opening Remarks

Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson

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9:10

A regulatory round up from the office of combination products

John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA

  • An insight into the office of combination products current focus with regard to pre-filled syringes and injectable drug delivery devices
  • Updates and clarifications on current projects including:
  • Reliability guidance for emergency use injection systems
  • Essential performance requirements
  • Human factors studies
  • ICH Q9
  • Bridging studies guidance
  • Looking to the future, what can we expect from the office of combination products; evaluating feedback from industry and assessing needs for clarified or updated guidance
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    9:50

    Combination Product Essential Performance Requirements; Interpretation and Control Strategy Development – A BioPhorum Appraisal

  • Interpretation and classification of EPR’s along the lines of ICH Q9 
  • Challenges to define and identify EPRs during the development of a combination product
  • Applying EPR’s during device development and manufacture via control strategies. Review of an acceptable test plan or control strategy for each EPR, including evaluation of potential substitute testing and reducing burden on batch-release testing.
  • Traceability matrix demonstrating all the essential performance requirements have been adequately verified and validated 
  • Anticipated feedback in response to FDA Q1 2023 draft-guidance
  • Eric Houde, Senior Manager Combination Products, Regeneron

    Edwin Lyons, Associate Director – Head of Medical Devices, CSL Behring

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    10:30

    Panel Discussion: Evaluating the pre-filled syringes and injectables drug devices regulatory landscape

  • Delving into the FDA’s efforts towards harmonization and convergence
  • Key challenges in multi-market launches, industry examples and experiences
  • Where are we seeing challenges in consistencies across jurisdictions internationally and across the EU
  • How can the FDA and industry align to improve processes for engaging with regulatory bodies
  • John Barr Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA

    John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson

    Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals

    Joyce Zhao, Director, Combination Product, Takeda

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    11:10

    Morning Coffee

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    11:40

    Regulatory considerations for large volume injectors: autoinjectorscompared to on body delivery systems

    John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis

  • Drawing on previous projects and a review of FDA approvals
  • What are the complexities that need to be addressed and the similarities and nuances between autoinjector and wearable systems
  • Perspectives from individual device development stages and how do the regulatory considerations of each impact development strategy?
  • Assessing user needs and reviewing when the preferred large volume delivery system has been different to original assumptions
  • Impacts from health authorities in the US and the EU
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    12:20

    High dose/ high volume Subcutaneous Drug Delivery Systems - Patient Preference Study (PPS)

  • High dose/ high volume subcutaneous drug delivery project objective
  • Patient Preference Study (PPS) creation and its role in achieving the project objective
  • Implementing IMI PREFER in PPS design
  • Lauren Ziegler , Senior Director Medical Devices, Novartis

    Andrew Susott, Director of Human Factors / User Experience, Global Device & Packaging Development, Novartis

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    13:00

    Enhancing Primary Containers With Smart Labelling Solutions

    Christian Liebl, Senior Innovations and Process Manager, Schreiner MediPharm

  • Enhancing Primary Container With Smart Labelling Solutions
  • Digital and Analog Tamper Evidence / Proof of Sterility
  • Enhanced UV protection to mitigate photo instability
  • Significantly reduce Oxygen ingress in polymer containers
  • Enhance RFID performance
  • And much more!
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    13:30

    Networking Lunch

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    14:30

    Collaboration to meet market demand for dual chamber drug/device combination products: Combining innovation in drug delivery devices and pharmaceutical contract manufacturing

  • The need for various Dual Chamber solutions to meet ‘Ready-to-Use’ requirements
  • Trends in Dual Chamber applications: Reconstitution and Sequential injection
  • Credence MedSystems and Bryllan: The capabilities the collaboration provides to pharmaceutical manufacturers 
  • Accelerated scaling approaches to meet increased industry demand for dual chamber syringe technologies
  • John Merhige, Chief Commercial Officer, Credence MedSystems

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    15:00

    Assessing the industry landscape and growing advances for subcutaneous delivery of high-dose and high-volume biologics

    Deep S Bhattacharya, Senior Scientist Formulation and Process, Development- Biotherapeutics, Pfizer

  • The challenges and opportunities for subcutaneous delivery of high dose/volume biologics
  • The potential to apply novel subcutaneous technologies to several therapeutic areas through collaborations across industry
  • Summarizing key patient and HCP perceptions of high dose/volume subcutaneous delivery
  • Insights into developing subcutaneous technologies that could further facilitate high dose/volume subcutaneous administration
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    15:40

    A Glass Alternative: ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) for Pre-Filled syringes

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials

  • Key Benefits of COP for Medical Devices 
  • Case Study on Delamination: COP Syringe vs Glass Syringe 
  • Case Study on Protein Adsorption/Aggregation and its effect on Immunogenicity
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    16:10

    Afternoon Tea

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    16:40

    Latest data for multilayer plastic vial

    Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc

  • Multilayer plastic vial
  • Oxygen barrier for stabilization of biologics
  • Ultraviolet light barrier for stabilization of biologics
  • Extremely low inorganic extractables & pH stability
  • Low risk of breakage at extremely low temperature
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    17:10

    Use of Weibull Analysis to Estimate Time of Needle Clogging in Pre-filled Syringes Filled with Fast Drying Propensity Drug Produc

    Lynne Liao, Sr. Engineer, Device Development, Alexion Pharmaceuticals

  • Specific drug product formulations could have a propensity to rapidly dry, which may cause needle clogging either at the point of use (once the needle shield is removed) or upstream (during the syringe filling process).
  • This study was designed to characterize the time for prefilled syringes to clog after the needle shield was removed.
  • A Weibull analysis was used to predict the time to clog. This approach allowed for product reliability to be directionally established (and the risk of rapid drying to be assessed) with limited samples.
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    17:50

    Chairman’s Closing Remarks and Close of Day One

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson

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    18:00

    End-of-Day-One Networking Reception

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson

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    9:10

    Digital Transformation’s Impact on Quality Engineering and Combination Products

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson

  • Quality 4.0 provides an effective framework to transition from a compliance-based, reactive, error-prone, and siloed Quality Management System (QMS) to the one that is proactive, integrated, efficient, and most importantly patient centric, thanks to current digital tools.
  • Adoption of Quality Management System would result in process and systems agility, efficiency, and flexibility, while breaking the silos in product development and validation.
  • Digital transformation will improve efficiency and productivity of Combination Product's Development and Qualification
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    9:50

    Investigating Factors that Affect Plunger Stopper Motion During Simulated Shipping of Pre-Filled Syringes

    Kirk Roffi, Senior Scientist, Pfizer

  • During high-altitude shipping of pre-filled syringes, pressure differentials can cause the elastomer stopper to move unintentionally
  • This motion represents a risk to container closure integrity and drug product sterility
  • We applied laser displacement sensors to measure stopper motion in real-time under laboratory conditions 
  • A physical interpretation is developed by comparing experiments with 1) a frictionless ideal gas model (Boyle’s Law), and 2) a dynamic model in Matlab-Simulink that uses empirical friction laws to represent the elastomer-glass and elastomer-silicone oil contacts inherent to the lubricated interference fit
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    10:30

    Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson

  • Advancements in Drug Delivery – Convergence of Drug Product Development and Medical Technology
  • Historical review of various routes of administration
  • Role of the Patient driving changes in delivery approaches
  • Convergence of Drug Development and Minimally Invasive procedures
  • Examples of Current and Future Technologies
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    11:10

    Morning Coffee

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    11:40

    Device Development for Long Acting Injectables

    Scott Nunn, Director, Device Development, Gilead Sciences, Inc

  • Patient Drivers for Long Acting Injectables
  • How have long-acting injectable devices evolved in recent years
  • Formulation and device considerations for long acting injectables
  • Common pitfalls and challenges in long-acting combination product design
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    12:20

    Digital Integration of Medical Devices

    Ning Yu, Director, Product and Technology Development, Biogen

  • Considering human-centred design and producing devices tailored to improve adherence
  • Case studies on the use of digital solutions
  • Challenges with regulatory guidance
  • How to capture novel opportunities in digital health
  • The future of digital systems and increasing acceptance
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    13:00

    Challenges and Root Cause Mechanisms for Container Closure Integrity During Freeze/Thaw Cycles in Deep-Cold Storage of Pre-filled Systems

    Ludovic Gil, R&D Senior Engineer - Product Engineering, BD Medical - Pharmaceutical Systems

  • The emergence of new drug technologies, such as mRNA (messenger ribonucleic acid), has driven increased demand for delivery solutions capable of withstanding deep-cold storage conditions sometimes down to -80°C [1]. While significant data exist for deep-cold storage in vial format [2,3], not much information is available for the pre-filled syringe (PFS) format. 
  • Since PFS serve as both storage container and final delivery system, additional requirements such as plunger-stopper break-loose and gliding forces, and stability of the syringe’s lubrication must be evaluated after Freeze-and-Thaw (F/T) cycle [4]. In addition, container closure integrity (CCI) must be maintained during F/T cycle and storage, including stopper movement during multiple F/T cycles. Previous studies have demonstrated that maintaining CCI down to -80°C in glass PFS is one of the main challenges as the plunger stopper-barrel sealing tightness is significantly impacted by rubber glass transition [4, 5, 6]. 
  • In this study, we confirm that the rubber Tg is one of the main parameters determining the CCI performance in deep-cold storage conditions. Moreover, we show that additional physics need to be accounted for to characterize the complex coupled mechanisms of CCI breach.
  • clock

    13:30

    Networking Lunch

    clock

    14:30

    Unlocking Blow-Fill-Seal Technology for Prefilled Injectables

    Tony Wasilewski, Vice President, Pharmaceutical Development Services, Apiject

  • Creating the Next Generation of Prefilled Injectables
  • Evolution of Delivery Devices to Address User Needs
  • Key Considerations When Transitioning to a Novel Device
  • The Future of Connectable Components, Designed to Provide Flexibility for a Wide Range of Injection Needs
  • clock

    15:00

    Innovation in Drug Delivery Combining Human Factors and AI

    James Leamon, Director Device Development, Device Development

  • New developments in Drug Delivery
  • Human Factors impact on device development and human safety
  • Artificial Intelligence and Human Factors
  • The New Needs for the next generation Delivery Device
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    15:40

    Releasing pen injectors as combination products for clinical trial use: regulatory, QA and QC aspects

    Konrad Betzler, Vice President Quality, Haselmeier

  • Regulatory hiking map
  • Drug Product and Pen Injector Development in parallel
  • Pen Injectors as combination products
  • Requirements for releasing a batch for clinical trial use
  • Controlling finished batch compliance
  • clock

    16:10

    Afternoon Tea

    clock

    16:40

    Design for Sustainability - Pharmaceutical Packaging & Medical Devices

    Shruti Parikh, Associate Director Product Development, Takeda Pharmaceuticals

  • The current landscape and industry movement towards sustainable practices
  • The role LCAs can play in strategic decision making at the corporate level
  • Design for sustainability process
  • Trends & Case Studies
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    17:20

    Finished Good Packaging Development for Device and Combination Product

    Ellie Younger, Head of Sustaining Engineering, Biogen

  • Key packaging challenges related to device selection and impact to the supply chain
  • Case study: Sustainable Packaging as a LCM project for a commercial PFS product
  • Development of new pharma packaging standard
  • clock

    18:00

    Chairman’s Closing Remarks and Close of Day Two

    Alie Jahangir, Sr. Principal Engineer, Product Quality Management, Johnson & Johnson


    Sr. Principal Engineer, Product Quality Management
    Johnson & Johnson
    Director of Human Factors / User Experience, Global Device & Packaging Development
    Novartis
    Senior Innovations and Process Manager
    Schreiner MediPharm
    Senior Scientist Formulation and Process, Development- Biotherapeutics
    Pfizer
    Associate Director – Head of Medical Devices
    CSL Behring
    Head of Sustaining Engineering
    Biogen
    Senior Manager Combination Products
    Regeneron
    Researcher
    Mitsubishi Gas Chemical Company, Inc
    Director Device Development
    Device Development
    Associate Director for Policy and Product Classification Officer
    Office of Combination Products, FDA
    Chief Commercial Officer
    Credence MedSystems
    Executive Director, Senior Global Program Director Regulatory Affairs
    Novartis
    Director, Combination Product
    Takeda
    Sr Engineer III
    Biogen International GmbH
    Senior Scientist
    Pfizer
    Vice President Quality
    Haselmeier
    Strategic Business Development Manager
    Zeon Specialty Materials
    Senior Director Medical Devices
    Novartis
    Head of Packaging Development
    Biogen International GmbH
    R&D Senior Engineer - Product Engineering
    BD Medical - Pharmaceutical Systems
    Sr. Engineer, Device Development
    Alexion Pharmaceuticals
    Senior Manager Regulatory Affairs
    Regeneron Pharmaceuticals
    Director, Product and Technology Development
    Biogen
    Director, Device Development
    Gilead Sciences, Inc
    Associate Director Product Development
    Takeda Pharmaceuticals
    Head of Design & Innovation
    Johnson & Johnson
    Vice President, Pharmaceutical Development Services
    Apiject

    Sponsors

    Exhibitors

    Official Media Partner

    Pre-Filled Syringes East Coast Preliminary Attendee list

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    Pre Filled Syringes East Coast 2023 Brochure

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    Past Attendee List

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    Pre-filled Syringes and Injectable Drug Devices Worldwide Survey 2022

    Download

    Short Programme

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    Long Programme

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    Speaker Biographies

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    Conference Chair Invitation Letter

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    Sponsors


    ApiJect™

    Sponsors
    https://info.apiject.com/industry-events

    ApiJect™ is a global medical technology company creating the future of pharmaceutical injections.

    Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume. 

    Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.  

    The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.



    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    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.


    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.



    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Schreiner MediPharm

    Sponsors
    http://www.schreiner-medipharm.com

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.


    ZEON

    Sponsors
    http://www.zeonex.com

    ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns.

    Exhibitors


    Exela

    Exhibitors
    https://www.exelapharma.com

    Exela Pharma Sciences, established in 2005 is a US based specialty pharmaceutical company located one hour west of Charlotte Douglas International Airport in Lenoir, North Carolina. Exela has two distinct and separate business units, a Finished Drug Products organization, manufacturing proprietary and generic sterile injectable products and a Contract Development and Manufacturing Organization (CDMO). Both businesses leverage significant cGMP sterile injectable manufacturing capabilities with capacity in liquid vials, lyophilized vials, pre-filled syringes, and IV bags. Exela has a proven track record of program execution under intense time pressures with exceptional service.

    The CDMO business is fully capable of meeting the manufacturing of pharmaceutical and biotech industry needs. Exela offers end to end contract manufacturing capabilities, from analytical development to large scale cGMP manufacturing, along with automated inspections, labeling and packaging services. Exela can also provide a dedicated team to address your warehousing, storage, and global distribution needs. Exela has the capacity for commercial supply in the tens of millions of units.

    For more information, or to receive a quote on our CDMO services, please contact Matt Delaney, VP Business Development for Exela at 512-922-2839, or by email at: gdelaney@exela.us.



    MESA LABS

    Exhibitors
    https://mesalabs.com/

    Known globally for our experience and expertise, Mesa Labs manufactures ANSI/AAMI/ISO-, and USP-compliant indicators for a wide range of sterilization modalities. Our products and custom solutions offer convenient and consistent ways to validate and monitor the compliance of your processes and products.



    Nipro PharmaPackaging

    Exhibitors
    http://www.nipro-group.com

    Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform. Through our personnel, products, and services, Nipro PharmaPackaging enables you to provide a safer and healthier administration to your customers. Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 35,000 employees worldwide, Nipro serves the Pharmaceutical, Medical Device, and Pharmaceutical Packaging industries.


    Noble

    Exhibitors
    https://www.gonoble.com/

    Noble and Metaphase an Aptar pharma company, provide expertise and the “voice of the patient” in product design, user-experience research, human factors, along with tailored training & on-boarding solutions to help our clients Ideate, Validate, and Educate throughout the product development process. In addition, Noble manufactures and commercializes training devices. These devices mimic the exact feel, force, and function of drug delivery devices such as autoinjectors, prefilled syringes, onbody, nasal and pulmonary devices in order to increase patient adherence and confidence and decrease usage errors. Noble was founded in 1994 and is based in Orlando, Florida. For more information, visit www.gonoble.com.



    Owen Mumford

    Exhibitors
    http://www.owenmumford.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.

    For more information please visit https://www.ompharmaservices.com/



    Raumedic

    Exhibitors
    http://www.raumedic.com

    RAUMEDIC serves Pharma / Biopharma / Cell and Gene Therapy - with first class tubing for fluid transfer and fluid handling applications.

    Benefit from Raumedic's 70+ years of experience as a single source tubing supplier - with an in-house materials department, in-house product development and tried and trusted manufacturing expertise at five different production sites in three countries.

    With Raumedic as your supplier, you can count on:

    Standards compliance and validation

    Biocompatibility

    Low extractable values

    Increased flow rates / Cell Growth yield

    Discover innovative tubing from Raumedic - In stock and ready to ship!

    • Standards compliance and validation

    • Biocompatibility

    • Low extractable values

    • Increased flow rates / Cell Growth yield

    • Platinum cured Silicone Tubing

    • Platinum cured Braided Silicone Tubing (high pressure)

    • Thermoplastic Elastomer Tubing (TPE)

    • Tubing sets - bespoke customer design



    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.


    Media Partners


    ASD MEDIA

    Official Media Partner
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.


    Pharmiweb

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

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    On Drug Delivery

    Official Media Partner
    http://www.ondrugdelivery.com/subscribe

    ONdrugDelivery provides 30,000 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: www.ondrugdelivery.com/subscribe.


    Pharmaceutical Technology

    Official Media Partner
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    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.


    American Pharmaceutical Review

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

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    evvnt Ltd

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

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    Drug Discovery Today

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

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmaceutical Outsourcing

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

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    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


    Gene Therapy Net

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

    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    World Pharma News

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


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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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