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SMi are proud to announce the 8th Pre Filled Syringes East Coast virtual conference taking place on 26th and 27th April 2021.

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.

This comprehensive overview will help attendees understand the changing global market and the challenges faced within the industry. The upcoming conference will cover key topics driving the industry including: advancing development for drug delivery devices, regulatory updates including the FDA draft guidance on bridging studies, connectivity and digital health for combination products and compatibility for drug delivery systems.
 

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.


We look forward to welcoming you to the conference in April 2021.

 

Pre-Filled Syringes East Coast will explore industry updates and considerations for PFS platforms and integrated development. Gain insights into the industry acceleration towards connectivity following the pandemic through case studies on connected devices and virtual studies. Hear from leading regulatory experts on international guidance, EU MDR, bridging studies and convergence opportunities. Delve into real world examples of advancing injectable device development and global health priorities for pre-filled syringes.

 

The SMi Virtual Conference Platform will deliver the following benefits:

  • Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
  • Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
  • Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
  • Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality


 

  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

Previous attendees include:

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc;
 

Conference programme

8:30 Chair's Opening Remarks

Susan Neadle

Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson

8:40 Combination Products Integrated Development

Susan Neadle

Susan Neadle, Senior Director, Global Value Chain Quality Design, and Head, Combination Products CoP, Johnson & Johnson
View Bio

  • Combination Products Regulations are evolving globally 
  • One consistent undercurrent to this dynamic regulatory environment is the drive for successful practices and control strategies throughout the combination product lifecycle, to assure public health, ensuring risk is commensurate with product complexity and patient needs 
  • In this presentation we’ll review combination products integrated development and risk management considerations and essential performance requirements to support robust product development and lifecycle management

     

  • 9:30 A holistic overview of the injector system development process

    Michael Song

    Michael Song, Associate Director, Takeda

  • An insight into the key stages of device development for pre-filled syringes and combination products
  • How a better understanding of cross functional activities beyond device development can allow for a more integrated approach
  • Considerations in device development strategy
  • A future outlook of pre-filled syringes development and guidance for a more integrated device portfolio strategy 
  •  

    10:10 Morning Break and Virtual Exhibitor Hall Open

    10:40 Optimizing development for pre-filled syringes platforms

  • An industry outlook on platforms for pre-filled syringes
  • Documentation creation and management strategies, challenges, and considerations throughout life of program
  • User population definitions and human factors studies as a one-size-fits-all approach
  • Use of characterization and DV&V to support the platform program and project teams
  • Challenges and limitations of testing and potential solutions

     

  • Kathleen Gove

    Kathleen Gove, Senior Device Development Engineer, Regeneron Pharmaceuticals
    View Bio

    Matthew McKay

    Matthew McKay, Device Development Engineer, Regeneron Pharmaceuticals
    View Bio

    11:20 Changes to human factors studies in response to the pandemic

    Young Chun

    Young Chun, Lead, Human Factors and User Research, Takeda Pharmaceutical Company Limited
    View Bio

  • Identifying whether a study can be run as remote and when is an in-person study needed?
  • Process considerations and ensuring reliable remote studies
  • Examples, challenges and key takeaways from in-person studies during the pandemic
  • Assessing regulatory requirements and can we expect remote studies to continue post-pandemic?
  • 12:00 Global health priorities for prefilled delivery devices

    Courtney Jarrahian

    Courtney Jarrahian, Portfolio Leader, Packaging and Delivery Technologies, PATH
    View Bio

  • Use of prefilled delivery devices to meet public health priorities in low- and middle-income countries
  • Opportunities and value proposition for prefilled vaccines and essential medicines
  • Pathways to introduction of new compact, prefilled, autodisable devices in low-resource settings
  • Novel combination product technologies, including dual-chamber delivery devices and microarray patches
  • 12:40 Networking Break and Virtual Exhibitor Hall Open

    13:40 Improving subcutaneous injection for chronic care settings – Working together to innovate for impact

  • Understand how early collaboration enables us to build the right product the first time by designing around needs first rather than existing technology and its constraints
  • Explore how the default use of ½” staked needle prefilled syringes has impeded combination product innovation and imposed unnecessary constraints on drug manufacturers
  • Examine how an 8 mm staked needle prefilled syringe addresses the industry’s unmet needs:
  • Increase injection device design space, focusing on solutions with high viscosities and volumes
  • Reduce the injection/needle-related anxiety
  • Reduce the risk of accidental intramuscular injection (important consideration for risk management planning)
  • Maintain acceptable injection force and time for high-volume and high-viscosity drugs
  • Maintain needle mechanical resistance (needle bending and buckling)
  • Simplify user injection technique
  • Herve Soukiassian

    Herve Soukiassian, Senior program leader - Chronic therapeutics segment, Becton Dickinson (BD)
    View Bio

    Danielle Laiacona

    Danielle Laiacona, Device Development Engineer, Regeneron Pharmaceuticals, Inc.
    View Bio

    14:20 Evolving PFS and combination product regulations beyond the US

    Sally Wixson

    Sally Wixson, Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices, Janssen Research & Development
    View Bio

  • An update on the EU MDR: How has industry been adapting, considerations for dossier revisions and challenges around notified body opinion
  • Evolving international expectations beyond EU for combination products
  • Considerations for co-packaged combination products with stand-alone elements
  • Guidance on harmonizing documentation for international requirements
  • 15:00 Afternoon Break and Virtual Exhibitor Hall Open

    15:30 Lifecycle Management for Combination Products - An Industry Perspective

    Krystin Meidell

    Krystin Meidell, Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen
    View Bio

  • Overview of regulatory change assessments
  • Requirements and guidance in the US and upcoming rules in the EU
  • Case Study Example
  • Key considerations when conducting lifecycle management changes

     

  • 16:10 Combination Products Bridging Study Landscape and a Case Study

    Tieming Ruan

    Tieming Ruan, Sr. Director of Combination Products, Alexion Pharmaceuticals

  • Industry strategies to ensure correct bridging of clinical trials
  • Foreseeable effects of FDA draft guidance on bridging studies
  • A Case Study of combination products bridging study
  • 16:50 Chair’s Closing Remarks and Close of Day One

    8:30 Chair's Opening Remarks

    8:40 Notified body perspective on platform approaches and European recognition of platforms

    Julia Frese

    Julia Frese, Director, TUV SUD Japan Ltd.

  • How has the pre-filled syringes and combination products industry evolved in the use of platforms
  • Current notified body guidance and requirements for combination product platforms
  • Where do European regulations stand on recognition of platforms

     

  • 9:20 Convergence opportunities for combination products

  • Key differences and similarities between international regulations, standards and guidance for combination products
  • Explore opportunities and strategies for convergence in the combination products space, amidst ongoing efforts of convergence for devices, drugs and biologics across jurisdictions
  • Regulatory Implications of a digital future
  • Susan Neadle

    Susan Neadle, Senior Director, Global Value Chain Quality Design, and Head, Combination Products CoP, Johnson & Johnson
    View Bio

    Theresa Jeary

    Theresa Jeary, Technical Specialist & Scheme Manager, BSI
    View Bio

    Julia Frese

    Julia Frese, Director, TUV SUD Japan Ltd.

    Kristina  Lauritsen

    Kristina Lauritsen, Combination Products Regulatory Advisor, FDA/CDER
    View Bio

    10:00 Morning Break and Virtual Exhibitor Hall Open

    10:30 EU MDR and Article 117 Lessons Learned

    Theresa Jeary

    Theresa Jeary, Technical Specialist & Scheme Manager, BSI
    View Bio

  • An overview of current timelines and considerations for the 1 year delay
  • Examples and key takeaways from applications so far
  • Common pitfalls in documentation and reporting
  • Notified Body guidance on do’s and don’ts for a successful application

     

  • 11:10 An MHRA update on pre-filled syringes regulatory guidance

    11:50 The acceleration towards connectivity for pre-filled syringes and combination products

    Kristina  Lauritsen

    Kristina Lauritsen, Combination Products Regulatory Advisor, FDA/CDER
    View Bio

  • The pre-filled syringes industry’s continued growth and commitment in advancing the use of technology, software and wearables
  • A review of current regulatory guidance for PFS and combination products
  • A review of current guidance for connected devices and FDA’s new digital health center of excellence
  • The future of digital health in the PFS industry; what has changed in the past year and the key regulations to be considered
  • 12:30 Networking Break and Virtual Exhibitor Hall Open

    13:30 Connected Combination Products: The Industry Perspective

    Megan K. Doyle

    Megan K. Doyle, Global Policy Lead, Combination Products, Digital Health, and Diagnostics, Amgen
    View Bio

  • The industry is moving to incorporate digital components into combination products to improve the patient experience.
  • Connected Combination Products are one way to accomplish this, but few have been approved to date.
  • This presentation will address challenges in the development and review of connected combination products and other digital health priorities, from the industry perspective
  • 14:10 Technical Overview of COP for Prefilled Syringes

    Larry Atupem

    Larry Atupem, Sr Business Development Specialist, Zeon Specialty Materials

  • Key properties of COP
  • Case Study (New): 
  • Protein Adsorption of Abatacept – COP vs Glass
  • Immunogenicity test of the aggregates
  • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass
  • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • Leachable data on COP syringes
  • 14:50 Afternoon Break and Virtual Exhibitor Hall Open

    15:20 Biocompatibility of a Medical Device Combination Product: Prefilled Syringe as a Foundation for Other Delivery Devices

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
    View Bio

  • Foundational principles of biocompatibility of medical device/combination products
  • Regulatory expectations for biocompatibility 
  • Biocompatibility of a prefilled syringe
  • Biocompatibility of other delivery devices using the prefilled syringe as a foundational element
  • 16:00 A Holistic Industry Outlook of Testing and Development for Pre-Filled Syringes

    Prem Ganapathy

    Prem Ganapathy, Director, Head, Medical Device Test and Design Lab, Takeda
    View Bio

  • Takeda’s current portfolio of pre-filled syringes
  • Current device testing processes throughout the pre-filled syringes landscape
  • How can we improve current processes to ensure optimized PFS device testing and development?

     

  • 16:40 Chair’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Christine Lynn Lanning

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
    Courtney Jarrahian

    Courtney Jarrahian

    Portfolio Leader, Packaging and Delivery Technologies, PATH
    Danielle Laiacona

    Danielle Laiacona

    Device Development Engineer, Regeneron Pharmaceuticals, Inc.
    Herve Soukiassian

    Herve Soukiassian

    Senior program leader - Chronic therapeutics segment, Becton Dickinson (BD)
    Julia Frese

    Julia Frese

    Director, TUV SUD Japan Ltd.
    Kathleen Gove

    Kathleen Gove

    Senior Device Development Engineer, Regeneron Pharmaceuticals
    Kristina  Lauritsen

    Kristina Lauritsen

    Combination Products Regulatory Advisor, FDA/CDER
    Krystin Meidell

    Krystin Meidell

    Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen
    Matthew McKay

    Matthew McKay

    Device Development Engineer, Regeneron Pharmaceuticals
    Megan K. Doyle

    Megan K. Doyle

    Global Policy Lead, Combination Products, Digital Health, and Diagnostics, Amgen
    Prem Ganapathy

    Prem Ganapathy

    Director, Head, Medical Device Test and Design Lab, Takeda
    Sally Wixson

    Sally Wixson

    Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices, Janssen Research & Development
    Susan Neadle

    Susan Neadle

    Senior Director, Global Value Chain Quality Design, and Head, Combination Products CoP, Johnson & Johnson
    Theresa Jeary

    Theresa Jeary

    Technical Specialist & Scheme Manager, BSI
    Tieming Ruan

    Tieming Ruan

    Sr. Director of Combination Products, Alexion Pharmaceuticals
    Young Chun

    Young Chun

    Lead, Human Factors and User Research, Takeda Pharmaceutical Company Limited

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
    Christine Lynn Lanning

    Dr. Christine Lynn Lanning is a Distinguished Scientist in Safety Assessment at Merck. In this role, she provides oversight of the biocompatibility of medical devices and medical device combination products. She has a PhD from Duke University in Pharmacology/Toxicology and is Six Sigma Green and Black Belt Certified. She has been at Merck over 20 years with experience with both drug and device development. She has authored over 200 scientific reports and over 50 regulatory submissions.

    Courtney Jarrahian

    Portfolio Leader, Packaging and Delivery Technologies, PATH
    Courtney Jarrahian

    Courtney Jarrahian oversees a portfolio of projects at PATH advancing vaccine and pharmaceutical packaging and delivery technologies and is co-leader of the Microarray Patch Center of Excellence. In collaboration with private- and public-sector partners, she implements projects to develop, assess, and introduce combination products and medical devices, with a focus on user-centered design, technical development, human factors evaluation, health economics, manufacturing, regulatory pathways, and commercialization. She also serves on the World Health Organization’s (WHO) Immunization Practices Advisory Committee (IPAC) delivery technologies working group and is a member of PATH’s Research Ethics Committee.

    Danielle Laiacona

    Device Development Engineer, Regeneron Pharmaceuticals, Inc.
    Danielle Laiacona

    Danielle Laiacona is a Device Development Engineer with Regeneron’s Combination Products New Technologies Management team, where she leads collaboration projects with medical device partner companies to identify innovative delivery solutions for Regeneron’s patients. Danielle earned her MS in Biomedical Engineering from Binghamton University with a focus on skin biomechanics

    Herve Soukiassian

    Senior program leader - Chronic therapeutics segment, Becton Dickinson (BD)
    Herve Soukiassian

    Hervé Soukiassian joined BD-Pharmaceutical Systems business 12 years ago and is currently the leader for Product Development pertaining to Prefillables Syringes for Chronic therapeutic segment. He has also contributed actively within the PDA – currently engaged in the PDA task force “Achieve Zero visible particles injecting into patients”- and is one of the co-author of the Technical report 73 “Prefilled Syringe User Requirements for Biotechnology Applications”. Prior to joining BD, Herve worked for 13 years at Hewlett Packard in various positions gaining experience and developing expertise in the field of process engineering – learning and applying key concepts of Total Quality Control, Design for Manufacturing, Just in Time, Single Minute Exchange of Die, Theory of constraint. He later joined the board of Directors of ActiCM, a start-up company associated with the “Commissariat a l’Energie Atomique (CEA)” and specialized in optical Coordinate Measurement Machines.
    Herve graduated from the "Institut National des Sciences Appliquées" of Lyon as a mechanical & industrial engineer. He also holds a master’s degree in material sciences.
     

    Julia Frese

    Director, TUV SUD Japan Ltd.
    Julia Frese

    Kathleen Gove

    Senior Device Development Engineer, Regeneron Pharmaceuticals
    Kathleen Gove

    Kathleen Gove graduated from Clarkson University in 2012 with a BS in Mechanical Engineering and a minor in Biomedical Engineering. Kathleen completed her doctorate in biomedical engineering from Dartmouth College in 2017 and went on to work in product development in the field of Orthopedics. Kathleen then joined Regeneron in 2019 as a senior device development engineer working on clinical programs and leading platform initiatives to improve the speed to clinic for project teams.

    Kristina Lauritsen

    Combination Products Regulatory Advisor, FDA/CDER
    Kristina  Lauritsen

    Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.

    Krystin Meidell

    Senior Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen
    Krystin Meidell

    Krystin Meidell works with the Regulatory CMC Medical Devices and Combination Products group at Biogen where she has supported combination product regulatory strategy for the past two years, including digital health. Prior to joining Biogen, Krystin’s experience includes global regulatory and analytical roles in active medical devices and software, drug delivery, and diagnostics. She holds a Bachelor of Science degree in Chemical Engineering from Carnegie Mellon University.

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Larry Atupem

    Matthew McKay

    Device Development Engineer, Regeneron Pharmaceuticals
    Matthew McKay

    Matt graduated from Lehigh University in 2017 with a BS in Bioengineering- Biopharmaceutical Engineering. Upon graduation, Matt worked at BD as a new product development engineer working on a wearable, on-body injection system. In 2018, Matt started at Regeneron as a device development engineer. During his time at Regeneron, Matt has worked on clinical and commercial product developments as a technical lead and currently works on the platform initiative.

    Megan K. Doyle

    Global Policy Lead, Combination Products, Digital Health, and Diagnostics, Amgen
    Megan K. Doyle

    Megan Doyle is an attorney with more than 10 years advising on matters pertaining to the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s in public health from Johns Hopkins University. After seven years in the medical device practice at Hogan Lovells, she joined Amgen as a Senior Counsel for Health Regulatory. For four years, she counseled Amgen on drug, device, combination product, and diagnostic matters. In particular, she advised product teams developing new, innovative delivery devices and digital health solutions. She also served as the law department companion diagnostic lead, advising on the co-development process for teams developing targeted therapies that require a companion diagnostic. Currently, she is a Director in Amgen’s Global Regulatory and R&D Policy group, where she is the Global Policy Lead for Diagnostics, Digital Health, and Combination Products.

    Michael Song

    Associate Director, Takeda
    Michael Song

    Prem Ganapathy

    Director, Head, Medical Device Test and Design Lab, Takeda
    Prem Ganapathy

    Prem Ganapathy currently works as the Head of the Medical Device Test and Design Lab, where he is responsible for managing and overseeing Takeda’s internal medical device testing laboratory and external testing partners .Prem has a background in Biomedical engineering and is a Medical device professional with over 17 years of combined experience in Product development, manufacturing and operations , where his experience last 10 years spans drug delivery and insulin delivery systems.

    Sally Wixson

    Associate Director Regulatory Affairs, CMC. Combination Products and Medical Devices, Janssen Research & Development
    Sally Wixson

    Sally Wixson has over 20 years’ industry experience, working for the past 7 years in Regulatory Affairs preparing and executing global regulatory strategies and submissions for medical devices, drugs, and drug-device combination products in a variety of fields including: ophthalmology, cardiovascular, metabolism, immunology, and neurology.
    Sally has also held various roles in Regulatory Affairs and Preclinical R&D at Ethicon, Dr. Reddy’s Laboratories, Allergan, Integra LifeSciences, Merck, and Schering-Plough. Sally is Regulatory Affairs Certified (dual certified in drugs and medical devices), holds a MS and BS in Animal Science and Veterinary Medical Degree, and is an American College of Laboratory Animal Medicine Diplomate.
     

    Susan Neadle

    Senior Director, Global Value Chain Quality Design, and Head, Combination Products CoP, Johnson & Johnson
    Susan Neadle

    Susan Neadle has been working in the health care industry for almost 30 years. Her distinguished career includes integral leadership roles in R&D, Quality Engineering, and Quality Management Systems, spanning pharmaceuticals, medical devices, and consumer products. In her current role, Sr. Director, Global Value Chain Quality Design at Johnson & Johnson, she serves as Chair of J&J’s cross-sector Design Council, advancing world-class practices in product and process design and development to drive speed, simplification and robustness in development of customer-centric health care solutions across J&J. She also leads J&J's Combination Products cross-sector Community of Practice. Among several achievements, Susan led the team that defined and implemented the business model for Janssen (J&J’s Pharmaceutical sector) to meet Combination Products health authority regulations . Further, she has applied her Design and Process Excellence Blackbelt skills to drive and develop significant new products and business impacts. Her leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, J&J’s highest honor for innovation excellence. Susan holds numerous patents and publications, and frequently speaks in public venues. She is actively engaged in several industry working groups on a range of Combination Products topics, including ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, PDA and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice, and as Vice-Chair of the Combination Products Coalition PMSR Working Group. Prior to J&J she held R&D and commercialization roles at IBM, Unilever, and Organon Teknika. Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowship in the American Academy of Optometry.

    Theresa Jeary

    Technical Specialist & Scheme Manager, BSI
    Theresa Jeary

    Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

    Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.

    In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.

    More recently Theresa has worked as a consultant to the Medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations and re-joined BSI in August 2020, working as a technical specialist in the Medicinal and Biologics Team.

    Theresa is a regular presenter on combination products and Article 117 and regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.

    Tieming Ruan

    Sr. Director of Combination Products, Alexion Pharmaceuticals
    Tieming Ruan

    Young Chun

    Lead, Human Factors and User Research, Takeda Pharmaceutical Company Limited
    Young Chun

    Young J. Chun, Ph.D. is an associate director at Takeda Human Factors and User Research group.
    Young is leading human factors activities and providing technical leadership to support the development of devices and combination products for delivery of Takeda’s wide portfolio of drugs and biologics.
    Before joining Takeda, Young was at Biogen where she led human factors engineering activities and research throughout product development life cycle for various medical devices / drug delivery combination products in various platforms and led a SaMD (Software as a Medical Device) project. Prior to Biogen, Young worked as a human factors researcher and investigated Musculoskeletal Disorders (MSDs) and mental stress of automotive assembly line workers in the automobile industry and improved thousands of tasks and processes for the assembly lines. Young also edited a book ‘Industrial Standardization’ published by Korea National Open University Press and delivered a couple dozens of talks and presentations at national and international conferences.
    Young obtained her doctorate degree in Industrial Engineering from Texas Tech University, with specialty of Ergonomics/Human factors and holds M.E. and B.E. in Industrial and Informational Engineering received from Hongik University in Seoul, South Korea. She is an official member of Alpha Pi Mu and Human Factors Ergonomics Society and holds a Six Sigma Green belt.

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    VENUE

    Online Virtual Event

    Online Virtual Event , USA

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Sponsors


    BD Medical - Pharmaceutical Systems

    Sponsors
    http://drugdeliverysystems.bd.com

    As a partner of choice for the pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of ready-to-use drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems, self-injection systems and connected solutions that ensure smooth delivery, regardless of drug complexity, viscosity and dosing volume. We offer our expertise and resources to support their product launch and life cycle management through consultative, analytical and clinical services to help ensure drug compatibility and seamless systems integration, while accelerating time-to-market and reducing risk.

    More information available @ drugdeliverysystems.bd.com

    Contact us @ drugdeliverysystems.bd.com/contact-us



    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


    Almac Group

    Exhibitors
    http://www.almacgroup.com

    Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms (vials, ampoules, pre-filled syringes, auto-injector pens) includes:
    • - Pack design and prototype generation
    • - Labeling, assembly and secondary packaging
    • - Complex kit assembly
    • - Temperature sensitive storage
    • - Serialization
    Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner.


    PHC Corporation

    Exhibitors
    http://www.phchd.com/global/

    PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries.


    Polyplastics – TOPAS

    Exhibitors
    https://topas.com

    Polyplastics is the leading maker of TOPAS COC (cyclic olefin copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes, vials and cartridges. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission.


    Weiss-Aug

    Exhibitors
    http://www.weiss-aug.com/

    The Weiss-Aug Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery components and sub-assemblies.

    With specialized knowledge and state-of-the-art equipment, The Weiss-Aug group delivers the latest technologies for Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery.



    ZwickRoell

    Exhibitors
    www.zwickroell.com

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

    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.


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/PMEAST20

    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.


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    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.


    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

    Media Partners


    pharmaphorum

    Supporting Media Partners
    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


    Gate2Biotech

    Supporting Media Partners
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Pharmaceutical Technology

    Supporting Media Partners
    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.


    Pharmiweb

    Supporting Media Partners
    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.


    Pharma network magazine

    Supporting Media Partners
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    Drug Discovery Today

    Supporting Media Partners
    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.


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    pharmanews hq

    Supporting Media Partners
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the 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. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Pharmacircle

    Supporting Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Biocompare

    Supporting Media Partners
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    World Pharma News

    Supporting Media Partners
    http://www.worldpharmanews.com/



    Mednous

    Supporting Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmaceutical Outsourcing

    Supporting Media Partners
    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.

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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, SMI 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@smi-online.co.uk

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