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SMi Group presents its 6th Annual Pre-Filled Syringes East Coast 2019 Conference and Exhibition taking place on 8th, 9th April in Boston.
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.

This year’s agenda includes the following:
- New digital technology trends including the case-studies of wearable's and evaluation of connectivity.
- Regulatory Processes and Challenges, including home-based administration and compliance within a fast-changing landscape.
- Human factor studies, including live tests for usability, risk mitigation, needle safety with a patient centric focus.
- Innovative designs and drug delivery systems including device combination product challenges.
- The future of PFS, next generation syringes, biologics and addressing the emerging challenges of chemical compatibility.
- Interactive panel discussions led by industry experts.
- Development within injectables translated into device management.

 

With expectations of a huge growth in the Prefilled syringes and a prediction of the global market to reach $6.6 billion by 2020, this event is not to be missed.
Developing on our annual success, this event assembles an international audience with industry and regulation experts. With a rapidly expanding patient demographic, we need to ensure that the PFS industry is ready for the new generation of drugs. This event is critical to help you stay on top of the evolving market trends and the dynamic PFS environment.
 

Highlights and hot topics include:
- Evaluation of  human factor studies and patient centric devices.
- Manufacturing issues and successful outsourcing
- The future of PFS, with focus on wearables and connectivity
- Evaluation of regulatory changes and product troubleshooting
- Cybersecurity
- Large volume delivery systems

This event will surely provide a much-needed in-depth insight into the PFS field
 

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:
• Pre-filled Syringes
• Autoinjectors
• Wearables
• Device Engineering
• Human Factors
• CMC
• Injectables
• Sterile Manufacturing
• Packaging
• Regulatory Affairs
 

Aegerion; Alexion Pharmaceuticals; Alkermes; Alnylam Pharmaceuticals; Amgen; Aptar Pharma; Astrazeneca; Battelle; Baxter Healthcare; Bayer AG; BCM Group LLC; BD; BD Medical - Pharmaceutical Systems; Biogen; Biogen Idec; Catalent Biologics; Continuum; Covestro; Datwyler Pharma Packaging Usa; Drug Delivery Business News / WTWH Media; Drug Delivery Experts; Eli Lilly and Company; Fresenius Kabi USA; GSK; GSK Pharma; iO Lifesciences; Janssen; kaleo, Inc.; Key Tech; Luitpold Pharmaceuticals; Luitpold Pharmaceuticals Inc; Matchstick; MedImmune Inc; Merck; Minapharm Pharmaceuticals; Mitsubishi Gas Chemical America Inc; Mitsubishi Gas Chemical Company; Momenta Pharmaceuticals; Momenta Pharmaceuticals Inc; Nemera; Nipro PharmaPackaging; NN Precision Engineered Products; Novartis; Novo Nordisk A/S; Nypro; Otsuka Pharmaceuticals Co Limited; Owen Mumford; Owen Mumford Ltd.; Pfizer; PFIZER, INC.; Plastic Ingenuity Inc; Regeneron; Regeneron Pharmaceuticals Inc; Regeneron Pharmaceuticals, Inc.; Sagentia Ltd; Sanofi; Sanofi Pharmaceuticals; Schott AG; Schreiner Group LP; Schreiner Medipharm; Shire Pharmaceuticals Group; Shire US Inc; SHL - Pharma; Smithers Rapra; STERIS Corporation; STERIS FINN-AQUA; Suttons Creek Inc; Takeda; Takeda Pharmaceuticals International Co.; Terumo Europe N.V.; Terumo Pharmaceutical Solutions; Teva Pharmaceuticals USA; Topas Advanced Polymers; Worrell; Zafgen, Inc.; zebrasci inc; ZEON; Zeon Chemicals L.P.;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dhairya Mehta

Dhairya Mehta, Director of Device and Combination Products, Shire

9:10 An overview of the Regulatory Processes and Challenges within the constantly evolving Pre-filled syringes market

Tina Kiang

Tina Kiang, Deputy Director Science and Policy, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, FDA (Subject to Final Confirmation)

- Thorough update on new regulatory guidelines and how to successfully comply.
- Strategy control for combination products 
- Drug and device requirements for innovative designs.
- Challenges in applying device software regulation.
- Incorporating patient centricity into regulatory requirements. 
 

9:50 The Impact of EU Medical Device Regulation on Combination Products and the Industry Challenges

Hemal Mehta

Hemal Mehta, Manager, Global CMC-RA, Medical Devices and Combination Products, Janssen Pharmaceutical Incorporated
View Bio

• Overview of EU Medical Device Regulation (MDR), which becomes effective 26 May 2020
• Impact of EU MDR Article 117, which requires Notified Body review of the device constituent of single-entity combination products
• Challenges in interpreting Article 117 requirements, industry’s approach to addressing this uncertainty, and recent developments
 

10:30 Morning Coffee: Sponsored by Zeon

11:00 Comparing radiation modalities

Larry Nichols

Larry Nichols, CEO, Steri-Tek
View Bio

• Differences with electron beam, gamma and x-ray with Case studies
• Irradiation of the product with gamma
• E-beam advantages - less colouration and less degradation
• Disadvantages of e-beams.  Gamma has better penetration and can penetrate dense products
• Introduce own research
 

11:40 Challenges of integrating Combination Product Development into the drug development Process

Amit Khanolkar

Amit Khanolkar, Director, New Product Development Quality Engineering, Janssen
View Bio

• Life cycle management of products and common hurdles at each step
• Troubleshooting the big technical challenges in development and manufacturing 
• Successful integration of human factor studies
 

12:20 Networking Lunch

13:20 Partnering in the Development and Commercialization of Combination Products

Carl  Dabruzzi

Carl Dabruzzi, Senior Manager, Product Management, West Pharmaceutical Services
View Bio

• Not all handheld injectors need to look and feel the same
• Satisfying the need for a platform of wearable on-body injection systems
• Integrated Solutions: Focus on what you’re good at and let your partner do the rest
• Your partner’s engagement shouldn’t end when the product is launched
 

14:00 21st century cures act and how this new law has transformed digital health

Linda Ricci

Linda Ricci , Associate director for digital health, Office of device evaluation FDA (Subject to Final Confirmation)

• The fine line as to what is and what is not a device and how to interpret the law 
• Examples of developments that are not classed as devices
• Connectivity, regulations and prediction of tighter manufacturing controls
 

14:40 Evolution of regulatory strategy - creating a roadmap to define strategy and mitigate risks

John Schalago

John Schalago, Head of GRA Devices and Applications, Emd Serono
View Bio

15:20 Afternoon Tea: Sponsored by Zeon

15:50 Human Factors Considerations Throughout Pre-Filled Syringe Development

Nick Zampa

Nick Zampa, Sr Engineer Technical Development Human Factors & Risk Management, Biogeneral Incorporated
View Bio

• Early Human Factors techniques and tools for understanding user perspective and user needs
• How to ensure a human factor study is representative of use in everyday life, certifying that studies are truly patient centric
• Linking Risk Management and compliance with good design for the end user.
• Approaches and applications of different types of human factor studies throughout development with successful case-studies
 

16:30 Medical Apps: The User Interface is the Product

Molly Story

Molly Story , Head of Global Usability Engineering and Rism Management, Sanofi
View Bio

• Identifying the primary users
• Identifying the use cases and controlling the use-related risks
• Iterative (Agile) formative testing to ensure the app satisfies the user needs
• Final (summative) human factors validation testing
 

17:10 Translation of Market research and user needs to commercial project product specification

Sara Waxberg McNew (Subject to Final Confirmation)

Sara Waxberg McNew (Subject to Final Confirmation), Director Human Factors & Industrial Design Delivery Device r&D, Eli Lilly

• Ethnigraphics and a human factor exploration
• Translating the data into quantifiable specific requirements for engineering developments
• Requirements for testing and how to determine sample size and ethnigraphics
• Collaboration between design and human factors and bridging psychology and user satisfaction
 

17:50 Panel Discussion: Evaluation of the Medical Device Single Audit Program (MDSAP) – who has joined and what are the implications for the medical device industry

Dhairya Mehta

Dhairya Mehta, Director of Device and Combination Products, Shire

Molly Story

Molly Story , Head of Global Usability Engineering and Rism Management, Sanofi
View Bio

John Schalago

John Schalago, Head of GRA Devices and Applications, Emd Serono
View Bio

18:30 Chairman’s Closing Remarks and Close of Day One

Darin Oppenheimer

Darin Oppenheimer, Executive Director, Head Drug Device Centre of Excellence, Merck & Co.

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Darin Oppenheimer

Darin Oppenheimer, Executive Director, Head Drug Device Centre of Excellence, Merck & Co.

9:10 Overview of plastic vs glass and assessing the big shift towards favoring plastic

9:50 The best plastic syringe for biologics

Shota Arakawa

Shota Arakawa, Researcher , Mitsubishi Gas Chemical Company, Inc.
View Bio

• Assessing the downfalls of glass focusing on drug interference examples 
• Introduction of advanced polymer materials that are biocompatible with other components of the syringe
• Oxygen permeability for glass vs plastic 
• Innovative device systems to improve gas barrier 
 

10:30 Morning Coffee

11:00 Innovation amongst the silicon free movement

Senior Representative

Senior Representative, Name to be Confirmed, GSK

• Modifications of silicon and case studies
• Protein biologics and how to prevent aggregation and adsorption of the peptide
• Improving the gliding of the plunger without compromising efficacy
 

11:40 Cyclo Olefin Polymer (COP) – Technical Data Update

Toshiro Katayama

Toshiro Katayama, Product Manager, Zeon Chemicals L.P.
View Bio

• Key Properties of COP
• Case study:  Biologics formulation for COP syringe optimized to eliminating use of surfactant.
• Case study:  Study on Protein adsorption/aggregation – COP vs glass
• Case study:  Study on delamination with glass syringe vs COP syringe
• Leachable data on COP syringes with various chemicals
 

12:20 Networking Lunch

13:20 Mechanical compatibility, assessing the functionality and critical components between drug delivery devices with PFS

Joyce Zhao (Subject to final Confirmation)

Joyce Zhao (Subject to final Confirmation) , Device Lead, Combination Product Device Development, Takeda Pharma Ceuticals International

14:00 Challenges in developing high concentration formulations for combination products

Ramin Samadani

Ramin Samadani, Scientist, MedImmune
View Bio

• Importance of viscosity on injection force
• Excipients used to reduce intermolecular interactions
• Effect of shear thinning on injection time
 

14:40 Ensuring package design and product integrity, with common PFS complaints and potential adverse events

15:20 Understanding the supply chain with acute evaluation of CMO’s

Ismael  Del Pilar (Subject to final confirmation)

Ismael Del Pilar (Subject to final confirmation) , Supplier Relationship Excellence Lead Syringe Systems, Amgen Manufacturing Inc

• Ensuring CMO’s understand specific manufacturing technologies and regulatory processes. 
• Examples of how choice of CMO directly affects revenue 
• Outsourcing to CMOs and potential challenges 
• Does outsourcing always increase the efficiency of the supply chain?
 

16:00 Afternoon Tea: Sponsored by Zeon

16:40 Design device strategy for successful implementation of connected devices

Cedric Gysel

Cedric Gysel, Staff Device Engineer, Janssen

• Case study of i-smart, a smart blister tracking device
• Connectivity and data strategy for choosing the right programs
• Setting up the all-important device development programs
• Process of reorganising funding and financing for device development platforms
 

17:20 Early stage device development and understanding cyber security.

Michael Song

Michael Song, Sr. Manager, Drug Delivery and Device Development, Medimmune
View Bio

• De-risk evaluation in terms of early stage device development
• Digital estimations in terms of challenges for patience use and product integrity. 
• Case study evidence to advise against rushing digital tools to the market and how to ensure they are robust enough
• Advice on cyber security with new devices and the challenges within field.
 

18:00 Competition from alternative drug delivery systems and the future of PFS

Steve Bowman

Steve Bowman, Device Program Lead, Shire US Inc
View Bio

• Updates on microneedles, wearables and nanopatches
• Why choose to invest in nanotechnology and microneedles?
• Connectivity, where will we be in 10 years time?
• Global market trend predictions for PFS
 

18:40 Panel Discussion: GDPR and it’s implications on digital health

Darin Oppenheimer

Darin Oppenheimer, Executive Director, Head Drug Device Centre of Excellence, Merck & Co.

Sudeshna Dutta Ray

Sudeshna Dutta Ray, Senior Engineer Advanced Device Technology, Amgen Incorporated

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Sponsors and Exhibitors

VENUE

Sheraton Boston Hotel

39 Dalton Street, Boston, MA, USA

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

HOTEL BOOKING FORM

Sponsors and Exhibitors


Aptar Pharma

Sponsors and Exhibitors
http://www.aptar.com/pharma

Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


Harro Höfliger

Sponsors and Exhibitors
http://www.hoefliger.com

Harro Höfliger is located in Southern Germany with over 1250 employees. With an extensive portfolio of technical platforms, Harro Höfliger offers customer specific, special solutions for growing market segments, innovative products and new drug delivery systems. Its technology platforms and turnkey system solutions are always precisely tailored to the needs of the customer. This 100% customer focus and a high level of innovation have earned the company a leading market position. With a worldwide sales and service network. A member of Excellence United.


Mitsubishi Gas Chemical

Sponsors and Exhibitors
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 and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


Owen Mumford

Sponsors and Exhibitors
http://omdevicesolutions.com

Owen Mumford offer an integrated design and build service from a broad base of proven self-injection and blood-sampling platform devices and intellectual property. Find out more at omdevicesolutions.com or contact us at devicesolutions@owenmumford.co.uk


Steri-Tek

Sponsors and Exhibitors
http://www.steri-tek.com

Steri-Tek is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, pharmaceutical and other industries. Steri-Tek is a ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed facility. Particularly with sensitive materials and complex devices, Steri-Tek has developed a proprietary system for optimizing E-beam/X-Ray sterilization of drugs/biologics in combination devices, pre-filled syringes, implantables, bioabsorbables and other complex products.


West Pharmaceutical Services, Inc.

Sponsors and Exhibitors
http://www.westpharma.com/

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 net sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.


ZEON

Sponsors and Exhibitors
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.

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Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

HOTEL BOOKING FORM

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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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