SMi Group's 8th annual Prefilled Syringes 2016 conference & exhibition is Europe's leading event.

1. KEY BENEFITS FOR 2016:
• Spotlight case study from F.Hoffmann-La Roche on usability
challenges of PFS on combination products
• Amgen to demonstrate how human factor engineering can
reduce risks by design
• Sanofi R&D showcases the path to auto injectors
• Allergan explains their safety assessment of E&L when
developing PFS drug products
• GSK presents how to conduct thorough visual inspection of PFS
• Hear from regulator and join interactive discussions
to benchmark your PFS strategy against peers’
SMi Presents the 8th Annual Conference and Exhibition on...
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS
Tuesday 26th January 2016, Copthorne Tara Hotel, Kensington, London, UK
27-28
JAN
2016Copthorne Tara Hotel, Kensington, London, UK
Pre-Filled Syringes
www.pre-filled-syringes.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Group Booking Package Available.
For further information, please contact Fateja Begum on Tel +44 (0) 20 7827 6184
or email fbegum@smi-online.co.uk
Pre-filled Syringes: Development,
Packaging and Regulatory Considerations
Workshop Leader:
Horst Koller, CEO, HK Packaging Consulting GmbH
8.30am – 12.30pm
Bridging the Gap -
From Formulation to PFS Device Engineering
Workshop Leader:
Jean-Rene Authelin, Global Head, Pharmaceutical Engineering, Sanofi R&D
1.30pm – 5.30pm
CHAIRS FOR 2016:
Stephen Barat,
Executive Director, Non-Clinical & Translational
Sciences, Safety Assessment & Bioanalysis,
Allergan
Alphons Fakler,
Senior Packaging Expert,
Novartis Pharma AG
EXPERT SPEAKER PANEL INCLUDE:
• Jean-Rene Authelin, Global Head, Pharmaceutical
Engineering, Sanofi R&D
• Dominique Lavergnat, Senior Device Development
Engineer, F.Hoffmann-La Roche Ltd.
• Valerie Fenster, Sr. Manager, Human Factor Engineering,
Amgen
• Paul Kinsey, Product Leader - Visual Inspection & Leak
Detection, GSK
• Maedeh Bigdeli, Production Manager (Aseptics),
Barts Health Pharmaceuticals
BOOK BY 30TH SEPTEMBER AND SAVE £400 | BOOK BY 30TH OCTOBER AND SAVE £200 | BOOK BY 30TH NOVEMBER AND SAVE £100
Sponsored by
Accelerating the PFS Development Journey: The A-Z Guide to Develop
a Safe, Patient-Centric and Commercially Viable Drug Delivery Device!
@SMIPHARM
#PFSSMI
ImagecourtesyofNoxilizer

2. Directors, VPs, Chiefs, Heads, Principals, Managers of
• Pre-Filled Syringes/ PFS/ Injectable
• Scientist
• Medical/ Development/ Design/
Drug Device Engineering
• Sterile Manufacturing/
Packaging/ Production/
Operations
• CMC
• R&D
• Bioprocessing/
Bio-production
• QA/ QC
• Visual Inspection
• Safety Assessment
• Business Development
WHO SHOULD ATTEND:
8th Annual Pre-Filled Syringes
Day One | Wednesday 27th January 2016
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Alphons Fakler, Senior Packaging Expert, Novartis Pharma AG
INNOVATION AND DEVICE DEVELOPMENT
9.10 OPENING ADDRESS
How Do Patient-Needs Drive an Efficient Device Development
Process?
• Obtaining design inputs that inform and direct decisions
• Concept selection in a crowded and competitive device
technology market
• Identifying unmet patient-needs that drive development
David Blakey, Device Engineering, GSK R&D
9.50 Multi-Layer Plastic Syringe for Oxygen-Sensitive Drug
• Prevent oxidation of medicinal solution
• Low protein (medicinal solution) adsorption
• Low silicone pre-fillable syringe
Shun Ogawa, Research Manager,
Mitsubishi Gas Chemical Company, Inc.
10.30 The Path to Enhancing Medical Devices from Pre-Filled Syringes
to Auto Injectors
• The physics involved
• Modelling of the AI, IJT distribution
• Estimation of the variability
• Impact of the design methodology
Jean-Rene Authelin, Global Head, Pharmaceutical Engineering,
Sanofi R&D
11.10 Morning Coffee & Networking Break
11.40 The Update of Biologics, A Rising Demand for Innovative Safety
Systems
• Homecare and biologics, a growing trend in parenteral
• What technical challenges does it raise?
• Review of innovative safety solutions
Adrien Tisserand, Category Manager - Parenteral, NEMERA
HUMAN FACTORS ENGINEERING
12.20 REAL LIFE CASE STUDY: Assessing How to Reduce Risks by Design
Instead of Introducing Controls
• Reviewing the challenging concepts in terms of human factor
studies
• What training should be undertaken to ensure risk
management regarding human factors e.g. needle stick
injuries?
• What data can be shared on this? What observations can be
made?
Valerie Fenster, Sr. Manager, Human Factor Engineering, Amgen
13.00 Networking Lunch
14.00 SPOTLIGHT CASE STUDY: Review Usability Challenges of PFS and
How Human Factor Study Can Support the Setting of Specification
and Selection of a Rigid Needle Shield (RNS) Design
• Usability of combination products as a key factor for self-
administrated drug - challenges for PFS
• How human factor study can support and define design
inputs?
• Patient group study to asses performances of RNS on outer
design to reduce usability risks
Dominique Lavergnat, Senior Device Development Engineer,
F.Hoffmann-La Roche Ltd.
14.40 Human Factors (HF) Testing of Pre-Filled Syringes (PFS)
• What do regulators want from HF data?
• If I am using an existing PFS, what HF data do I need to
generate?
• HF validation studies for PFS - top tips
Richard Featherstone, Managing Director,
Medical Device Usability Ltd.
15.20 Human Factors Engineering Q&A for the Regulator
Vikas Jaitey, Deputy Manager & Pharmaceutical Assessor,
Licensing Division, MHRA
15.30 Afternoon Tea & Networking Break
MANUFACTURING - FROM START TO FINISH (PART1)
16.00 Designing for Sterilisation: Materials, Packaging and Other
Considerations
• Sterilisation methods, with focus on temperature sensitive
products
• Material and packaging selection
• Regulatory aspects of using novel, non-traditional
sterilisation methods
Stephen Morley, Vice President, Sales & Service, Europe,
NOXILIZER Inc.
16.40 Filling Accuracy a Key Concern to Be Reviewed
• How to ensure real-time filling accuracy
• Exploring the aseptic filling process in more detail,
specifically with low fill volumes
• Assessing how to fill high-viscosity formulations for dosing
accuracy
Speaker to be announced shortly
17.10 PANEL DISCUSSION: The Importance of Needle
Stick Protection - Assessing the Safety
• How can we enhance devices to reduce needle
stick injuries?
• What necessary steps are being taken to ensure a successful
safe pre-filled syringe for the end-user
• Reviewing protection mechanisms for consideration to
prevent needle stick injuries
Moderated by:
Alphons Fakler, Senior Packaging Expert,
Novartis Pharma AG
Panellist:
Richard Featherstone, Managing Director,
Medical Device Usability Ltd.
17.50 Chairman's Closing Remarks and Close of Day One
Register online at: www.pre-filled-syringes.com • Alternatively fax

3. 8th Annual Pre-Filled Syringes
Day Two | Thursday 28th January 2016
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Stephen Barat, Executive Director, Non-Clinical & Translational
Sciences, Safety Assessment & Bioanalysis, Allergan
COMBINATION PRODUCTS
9.10 OPENING ADDRESS
Pre-Filled Syringes: Understanding the Regulatory Challenges
• Prefilled syringes regulated as a medicinal product or a
medical device in EU (combination products - definitions
and examples)
• Regulatory pathways and data expected in the registration
dossier
• Usability studies - human factor engineeringclarity on
what’s expected?
Vikas Jaitey, Deputy Manager & Pharmaceutical Assessor,
Licensing Division, MHRA
MANUFACTURING - FROM START TO FINISH (PART2)
9.50 New Technologies and Market Trends for Cartridge
Components
• Market overview for container solutions
• Cartridges, a packaging solution used for biological drugs
• Cartridge components and next generation component
development - functional, chemical and quality
requirements
• Nested ready to use cartridge solutions
• New machine concepts - all in one
• Applications and delivery devices in combination with
cartridges
Christa Jansen-Otten, Director, Prefillable Syringe Systems
Platform, Europe, West Pharmaceutical
10.30 Morning Coffee & Networking Break
11.00 Conducting thorough Visual Inspection and Catching the
Problem before Recall
• Overview of requirements and regulatory expectations
• Certification, qualification and validation
• Practical considerations for ‘difficult to inspect’ products
Paul Kinsey, Product Leader - Visual Inspection & Leak
Detection, GSK
11.40 Infusing Solutions for Fast Track Registration
• How introducing 'simulated studies' during the
development of large volume polymer prefillable syringes
can help gain development time
• A robust data package to support market authorisation
application: Design control, HF engineering and clinical
studies
• How an original regulatory approach can assist with
securing drug regulatory pathway
Amandine Chiarello, North America & Europe Product
Manager, BD Medical - Pharmaceutical Systems
12.20 Networking Lunch
SAFETY ASSESSMENT
13.20 KETNOTE ADDRESS: Aseptic Services in the NHS
• Overview of aseptic services provided
• Dose banding and the future of aseptic services for the NHS
• Requirements of PFS and validation
Maedeh Bigdeli Soltani, Production Manager (Aseptics)
Barts Health Pharmaceuticals
14.00 IN THE SPOTLIGHT CASE STUDY: Bringing an Auto Injector to Market
• What are the challenges of bringing an auto injector the
market and maintaining supply?
• Assessing the stability and packaging elements, what’s
required?
• How can we enhance supply chain robustness in compliance
with the device regulatory review
Speaker to be announced shortly
14.40 Afternoon Tea & Networking Break
15.10 Safety Assessment of Leachables when Developing Pre-Filled
Syringes Drug Products
• An overview of leachables and need for safety assessment
will be presented
• Current best practices for safety evaluation as related to
the development of a pre-filled syringe combination drug
product will be discussed with examples
• Final PQRI best practice recommendations for leachable
safety assessment will be covered
Stephen Barat, Executive Director, Non-Clinical & Translational
Sciences, Safety Assessment & Bioanalysis, Allergan
15.50 PANEL DISCUSSION: Implementing GMP for PFS
Manufacturing and Logistics
• Zero tolerance - how to ensure complete sterile
operating environment?
• Assessing logistics’ impact on PFS and drug stability for
intended markets
• What if? Preparing for the worst and contamination:
How to manage the risks and what is the contingency plan?
Moderated by:
Stephen Barat, Executive Director, Non-Clinical & Translational
Sciences, Safety Assessment & Bioanalysis, Allergan
Panel will also be joined by speakers of the day
16.30 Chairman’s Closing Remarks and Close of Day Two
your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Leading Media Partner Supported by

4. HALF-DAY PRE-CONFERENCE WORKSHOP A
Tuesday 26th January 2016 | 8.30am – 12.30pm | Copthorne Tara Hotel, Kensington, London, UK
Pre-filled Syringes: Development,
Packaging and Regulatory Considerations
Workshop Leader: Horst Koller, CEO, HK Packaging Consulting GmbH
Overview of the Workshop:
This half-day workshop course will provide an overview of relevant aspects
regarding the development of a pre-filled syringe system. It will also focus on
the secondary packaging around the primary packaging container while
giving an insight of relevant regulatory topics.
Key Benefits of Attending:
The participants will learn how processes involved in primary packaging
manufacturing, filling and processing will influence quality and how to use
relevant equipment to guarantee reproducible quality. Participants will gain
a conclusive summary from various perspectives ranging from R&D,
technical, quality and regulatory compliance - which are all crucial to the
success of building a PFS system.
HALF-DAY PRE-CONFERENCE WORKSHOP B
Tuesday 26th January 2016 | 1.30pm – 5.30pm | Copthorne Tara Hotel, Kensington, London, UK
Bridging the Gap - From Formulation to PFS Device Engineering
Workshop Leader: Jean-Rene Authelin, Global Head, Pharmaceutical Engineering, Sanofi R&D
Programme
8.30 Workshop registration and morning coffee
9.00 Workshop leader introduction
9.10 Development of a PFS-System
• A holistic plan and considerations from vial to a PFS
• Latest advancements in secondary packaging system
and what needs to be aware of?
10.30 Morning Coffee & Networking Break
11.00 Regulatory Aspects - it’s not just about compliance
• Classification of a PFS
• Everyone is talking about extractables and leachables
but what are they and how to demonstrate data?
• Testing requirements and who should be in charge?
12.00 Discussion - Q&A
12.30 Closing Remark from Workshop Leader and
End of Morning Workshop
About the Workshop Leader:
Horst Koller is the CEO of HK Packaging Consulting GmbH.
Prior to becoming a consultant, Horst worked for Abbott
Diagnostic and SCHOTT Pharmaceutical Packaging with over
20 years’ industry experience. His consulting company is
focusing on technical, regulatory and QM-support around primary and
secondary packaging systems including medical devices.
Horst is an active member within the Technical ISO Committees TC76
and TC84, as well as a reputable figure in the PFS sector. He holds an
Engineering degree in Biotechnology from the University of Applied
Sciences in Mannheim, Germany.
About the Organisation:
HK Packaging Consulting provide expert advisory services for
development and production of primary and secondary
packaging in the pharmaceutical industry and medical devices,
ranging from technical to regulatory and QM-support areas.
Overview of the Workshop:
With tighter budget and timeline, formulation and drug device
teams need to work much more closely to ensure an optimised
downstream process -especially with a more complex biological
drug product. This workshop will give both formulation scientists
and device engineers an in-depth understanding on key
attributes affecting drug and device performance, which help
them select the best strategy when designing PFS.
The second half of the workshop will focus on the emerging
trend of auto injectors. The workshop leader will lead an
interactive discussion with participants to evaluate and assess
individual device’s advantages and weaknesses to enable
better decision making.
Key Benefits of Attending:
This half-day workshop will complement the plenary
conference and offer a much more intimate
classroom environment to attendees to learn and
discuss critical factors on biological drug formulation
and PFS device design strategy. Through interactive
discussion, delegates will gain a much more detailed
understanding of PFS, and mitigate risks in downstream
processing.
About the Workshop Leader:
Jean René Authelin is the Global Head of Pharmaceutical
Engineering at Sanofi R&D. He has an Engineering degree in
chemical Engineering from ENSIC (Nancy France), and a PhD
from The Institut National Polytechnique de Lorraine. He first
joined Rhone Poulenc in 1988 as a Chemical Engineer. In the
90’s he founded the Physical Quality function, dedicated to the
API crystalisation , drying, polymorphism, for which he was the
Global Head in Rhone Poulenc Rorer, Aventis and finally Sanofi
for over 10 years . In 1998 Jean Rene was nominated the Global
Head of Pharmaceutical Engineering.
Jean-Rene’s interests lie within thermodynamics of hydrates,
drug polymorphism, amorphous solids physics, drug stability,
crystalisation, nanoparticles engineering and processing, milling;
spray drying, fluid bed granulation, roller compaction, freeze
drying, fill and finish, pre-filled syringes and auto injectors.
He is the author and co-author of 18 publications, as well as
book chapters and the co-inventor of 9 patents.
Programme
13.30 Workshop Registration & Welcome Coffee
14.00 Workshop Leader Introduction
14.10 Understanding Formulation of Drug Early On
• Suitability of formulation for PFS
• Injection time and force on stability of drugs
• Flow rate, glide force and penetration force modelling
- how to relate this to device design?
15.30 Afternoon Tea & Networking Break
16.00 Should We Switch to Auto Injectors (AI)?
• From science to commerciality to usability
- pros and cons of AI
• Safety concerns and interaction with drug delivery
• Manufacturing challenges for PFS vs. AI
- from environment to fill/finish technology
• Decision – how and when should we choose AI?
• Comparison with other alternative/non-invasive
drug delivery options
17.00 Q&A - Discussion
17.30 Closing Remark of Workshop Leader and
End of Workshop

5. SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to
complement your company’s marketing strategy. Prime networking opportunities exist to
entertain, enhance and expand your client base within the context of an independent
discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from sponsoring our
conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
8th Annual Pre-Filled Syringes
27th - 28th January 2016
BD Medical
BD Medical - Pharmaceutical Systems is the partner of choice for the pharmaceutical industry. With innovative prefillable
syringes, self-injection systems, safety systems and needle technologies, we offer an extensive selection of solutions
designed to protect, package and deliver drug therapies. Our experts provide comprehensive system-based service and
full product solutions.
www.bd.com/products/categories/pharmaceutical
Medical Device Usability
Medical Device Usability is a human factors and usability consultancy specialising in pharmaceutical devices and
combination products. We develop, plan and perform formative and summative studies for pharmaceutical clients
in Europe, the US and Australia. Based in Cambridge UK, we have extensive experience with prefilled syringes,
pen injectors and autoinjectors.
www.medical-device-usability.com
Mitsubishi Gas Chemical
MGC is a leading company in the field of oxygen barrier and absorbing technology. Based on the existing experiences,
MGC has successfully developed multilayer plastic vial and syringe. They have the characteristics of extremely high
oxygen and water vapor barrier and others. MGC recommends using them for oxygen-sensitive drugs.
www.mgc.co.jp
Nemera
Nemera is a world leader in the design, development and manufacturing of drug delivery solutions for the pharmaceutical
industry, including contract manufacturing, development of custom devices and standard innovative products. Nemera's
expertise covers five modes of delivery: Parenteral (passive safety device for prefilled syringes Safe’n’Sound®, insulin pens,
implanters, autoinjectors), Ophthalmic (preservative-free multidose eyedroppers), Ear/Nose/Throat (spray pumps, valves
etc.), Pulmonary (DPIs, pMDI valves) and also Dermal and Transdermal (airless systems dispensers).
www.nemera.net
Nipro Pharma Packaging
Nipro is a global, fully integrated glass tubing manufacturer, supplying a large range of tubes, vials, ampoules, cartridges
and other glass products to the pharmaceutical (parenteral and generic), scientific and cosmetic international markets.
With our worldwide facilities we meet global specifications and provide continuity of supply to our customers.
www.nipro-pharmapackaging.com
Noxilizer
Noxilizer, Inc. provides room temperature nitrogen dioxide sterilization technology. NO2 sterilization has shorter cycles
(approximately 2 hours including aeration), operates with or without vacuum and is easily installed—an ideal solution for
prefilled syringes and drug-device combination products. Noxilizer provides contract sterilization services and sells
sterilization and decontamination equipment. The company has offices in the US, UK & Japan.
www.noxilizer.com
Owen Mumford
Owen Mumford offer an Integrated design and build service from a broad base of proven self-injection platform devices and
intellectual property. Our full service solutions have been trusted by 7 of the 10 most successful pharmaceutical companies and
many smaller organisations besides.
www.omdevicesolutions.com
West Pharmaceuticals Services
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.
www.westpharma.com
Want to know how you can
get involved?
Interested in promoting your services
to this market?
Contact Julia Rotar, SMi Marketing
on +44 (0) 207 827 6088, or email:
jrotar@smi-online.co.uk
2014/15 Conference Attendee Profile 2014/15 Attendee Geo-Split
Pharma
& Biotech 53%
Industry Experts 38%
Academia 4%
Regulatory 5%
UK 36%
Rest of World 14%
SPONSORED BY:
Europe 54%
Upcoming Events of SMi's
Pre-Filled Syringes Series
Pre-Filled Syringes East Coast
April 25-26 2016, New Jersey, USA
Pre-Filled Syringes West Coast
June 6-7 2016, San Diego, USA
Save the dates and recommend
your colleague to receive an
early bird discount!

6. FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
8TH ANNUAL PRE-FILLED SYRINGES 2016
Conference: Wednesday 27th & Thursday 28th January 2016, Copthorne Tara Hotel, Kensington, London, UK Workshops: Tuesday 26th January 2016
4 WAYS TO REGISTER
www.pre-filled-syringes.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
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