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plUs tWo inteRaCtive half-Day pRe-ConfeRenCe WoRkshops
TUESDAY 16TH JANUARY 2018, COPTHORNE TARA HOTEL, LONDON, UK
B: navigating the silicone layer
Workshop Leader: oliver valet,
Co-Founder, Rap-iD
13.30 - 17.00
highlights in 2018:
• Engage with the latest regulatory updates and guidelines
for ultimate product compliance and efficiency
• Discuss the emerging hot topic of combination products
and benchmark against other industry-leaders
• Participate in the increased focus towards digital
connectivity and smart devices for improved patient
adherence
• Follow approaches to human factors and end-user
engagement from formulation to after-market development
• Witness the latest insights into the broader market trends
of increased biologics attention and how to address these
challenges head on
ChaiRs foR 2018:
• alphons fakler, Group Head Risk Management,
novartis pharma
• Bettine Boltres, Technical Account Manager,
West pharmaceutical services
keynote speakeR:
• elizabeth Baker, Group Manager Licensing Division, mhRa
featUReD speakeRs:
• marcel mueller, Device Project Leader, novartis pharma
• Cedric gysel, Staff Device Engineer, janssen
• Carsten Worsoe, Principal Scientist, CMC Analytical Support,
novo nordisk
• vikas jaitely, Senior Manager CMC Regulatory Intelligence
and Pharmaceutical Science, merck
• susanne joerg, Head of Formulation Development, lonza
• orla Downes, Head of Business Development Unit,
Barts health pharmaceuticals
• Barry knight, Device Program Lead, UCB Celltech
• sudeshna Dutta Ray, Senior Engineer, Advanced Device
Technology and Innovation, amgen
• alexander jung, Senior Manager, Technology and
Innovation, Drug Delivery and Devices, Boehringer ingelheim
• Christian Dechant, Primary Packaging Director,
Boehringer ingelheim
SMi Presents Europe’s Leading 10th Annual Conference and Exhibition...
Copthorne Tara Hotel, London, UK
WORKSHOPS: 16TH
CONFERENCE:
17TH - 18TH
JAN
2018
Pre-Filled
Syringes Europe
www.pre-filled-syringes.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
aCaDemiC & gRoUp DisCoUnts availaBle @smiphaRm
#pfssmi
RegisteR By 29th septemBeR anD save £400
RegisteR By 31st oCtoBeR anD save £200
RegisteR By 30th novemBeR anD save £100
a: Combining ‘traditional’ human factors with smart drug
delivery devices for hybrid parenteral development
Workshop Leader: jacquie finn,
Head of Digital Health, Cambridge Consultants
08.30 - 12.30
Unveiling emerging trends for future industry leverage
sponsoReD By
Copyright©WestPharmaceuticalServices
letteR fRom the ChaiRs:
Dear participants,
ItiswithgreatpleasurethatwewelcomeyoutoparticipateinEurope’sleading
event on Pre-Filled Syringes for its centenary year of success. We are delighted
to chair this forum which has been drafted with great care to allow for the very
best discussions and engagement on crucial topics for our industry.
What will the future of the pharmaceutical market look like in Europe? Not only
will it face unique challenges nowadays with the Brexit approaching quickly
but also with the need to adapt to other trends. An increasing number of
generics and biosimilars will hit the market, more and more drugs will be self-
administered and a switch from blockbusters to drugs tailored to small patient
groups will require adapting procedures and mindset.
In this year’s conference, the patient will be in focus again. What can we do
to ensure patient adherence and mitigate application errors? How can we
improve our understanding of the patient experience? What are the actual
challenges a patient is facing while handling our devices? These are just
some of the questions the presentations and panel discussion will address and
illuminate from various aspects. Besides that, latest trends in the development
of both formulations and devices as well as challenges during life-cycle
management will be in scope.
Asallindustrytakesthesamepath,thisconferenceprovidestheidealplatform
to share best practices, benefit from lessons learned and network with other
experts in the field.
alphons fakler, Group Head Risk Management,
novartis pharma
Bettine Boltres, Technical Account Manager,
West pharmaceutical services
08.30 RegistRation & Coffee
09.00 Co-ChaiR’s opening RemaRks
alphons fakler, Group Head Risk Management,
novartis pharma
Bettine Boltres, Technical Account Manager,
West pharmaceutical services
RegUlatoRy UpDates
keynote aDDRess
09.10 latest RegUlations anD the impliCations foR the pfs inDUstRy
• Overview and guidance for key legislation related to PFS
• The changes ahead
• Determining regulatory routes
elizabeth Baker, Group Manager Licensing Division, mhRa
panel DisCUssion
09.50 inDUstRy feeDBaCk on RegUlation impaCt
• What has been the impact of regulations on
established products?
• What are your experiences with the implications of
regulation on the management of difficult formulations?
• How do you envisage the future of market surveillance?
• How have you adapted to the regulations so far?
moderator: Bettine Boltres, Technical Account Manager,
West pharmaceutical services
vikas jaitely, Senior Manager CMC Regulatory Intelligence
and Pharmaceutical Science, merck
marcel mueller, Device Project Lead, novartis pharma
10.30 moRning Coffee
DRUg-DeliveRy: fRom foRmUlation to maRket
11.00 CCi testing of syRinge BaRRels at Dimensional extRemes
faCing ReqUiRements of UpDateD Usp<1207>
• Background
• Description of test approach
• Calculation and sourcing of worst case samples
• Applied test method
• Test results
markus hemminger, Senior Engineer, f. hoffmann-la Roche*
11.40 an innovative ComBination pRoDUCt foR CaRDiology
in pRe-filleD syRinge pResentations
• A primer to atherosclerosis
• The development of combination products for
cardiovascular risk reduction
• Challenges encountered in a fast-changing environment
• Successful answers to global challenges
marcel mueller, Device Project Leader, novartis pharma
12.20 netWoRking lUnCh sponsoReD By
13.20 impaCt of steRilization on pRotein aggRegation anD
DegRaDation in a polymeR-BaseD pRe-filleD syRinge
system
• Importance for minimising risks of protein interaction with
surfaces and materials of the container closure system
to eliminate immunogenicity and ensure drug safety and
efficacy
• A system approach, including selection of suitable
sterilization method, will be required for minimizing a risk of
immunogenicity
• Steam sterilization can be the preferred method of
sterilization for pre-fillable syringes for use with therapeutic
protein products
takeuchi katsuyuki, Business Development
– Global Pharmaceutical Solutions, terumo
the fUtURe of DRUg DeliveRy pRoDUCts
14.00 impRoving patient oUtComes With mixeD Reality anD
aRtifiCial intelligenCe teChnologies
• How voice assistant technology, such as Amazon Alexa
and Google Home creates opportunities to improve
medication / therapy adherence and long-term patient
engagement
• How Microsoft Hololens can help train and engage field
clinical reps, healthcare professionals and patients with
drug delivery and instructions for use
• Leveraging voice-enabled technology to guide patients
and capture clinical trial data
kai Worrell, CEO, Worrell inc.
14.40 faCilitate meaningfUl DiffeRentiation of pRoDUCts By
estaBlishing a CUltURe of innovation
• Case study on fostering a culture of innovation
• Selected examples of how building on existing platforms
allows to differentiate existing products and deliver value
to the patient
stefan holzner, Senior Director Head of Device Development
& External Manufacturing, shire*
15.20 afteRnoon tea
engaging With patient neeDs in paRenteRal DRUg DeliveRy
15.50 the path to safe injeCtion With pRe-filleD syRinges
• What makes injection safe?
• Different aspects regarding use of polymer syringes vs glass
• Discuss the preferred closure for staked needle syringes
• Drivers, statistics and legislation for safety systems
• Market overview, current trends and new technologies
for self-injection solutions
Christa jansen-otten, Director, Product Management,
West pharmaceutical services
16.30 the valUe of a hUman-CentReD appRoaCh to
phaRmaCeUtiCal DeliveRy systems
• What is Human-Centred design and why does it matter?
• Meaningful innovation driven by Human-Centred Insights
• Examples: Training materials and device platforms
Cedric gysel, Device Engineer, Device Centre of Excellence,
janssen
17.10 Co-ChaiR’s Closing RemaRks anD Close of Day one
Register online at www.pre-filled-syringes.com
UpComing events
foR the DiaRy:
pRe-filleD syRinges east Coast
SHERATON BOSTON HOTEL, BOSTON, MA, USA
11TH - 12TH APRIL 2018
pRe-filleD syRinges West Coast
CROWNE PLAZA, SAN DIEGO, CA, USA
4TH - 5TH JUNE 2018
pre-filled syringes europe www.pre-filled-syringes.com
Day one | WeDnesDay 17th janUaRy 2018
*Subject to confirmation
08.30	 Registration & Coffee
09.00	 Co-Chair’s Opening Remarks
	Alphons Fakler, Group Head Risk Management,
	 Novartis Pharma
	Bettine Boltres, Technical Account Manager,
West Pharmaceutical Services
Usability from Human Factors Approaches
	KEYNOTE ADDRESS
09.10	Overcoming regulatory challenges within the PFS and
auto-injector development and lifecycle management
	 •	Current regulatory requirements within the EU and US
framework
	 •	Overcoming regulatory challenges to support global
development of pre-filled syringe platform technology and
technological advancement
	 •	Documentations requirements for MA filing
	 •	Handling of regulatory aspects of Post-Approval Change
related to pre-filled syringes within product lifecycle
management - European perspective
	Vikas Jaitely, Senior Manager CMC Regulatory Intelligence
and Pharmaceutical Science, Merck
09.50	Formulation Viscosity – Aseptic Manufacturing
Challenges, Human factor and patient need
considerations
	 •	Challenges faced during aseptic filling of viscous
formulations in pre-filled syringe and mitigating those
challenges
	 •	Human Factors – Human-Centered Design
	 •	Common user problems
	Orla Downes, Head of Business Development Unit,
Barts Health Pharmaceuticals
10.30 	 Morning Coffee
	PANEL DISCUSSION
11.00	Benefits and pitfalls of drug delivery
devices from auto-injectors to
pre-filled syringes
	 •	What do we prioritise: Cognitive usability or physical
ergonomics?
	 •	How can we engage more with Human-Centred design in
the development of new devices?
	 •	How should we overcome the issues of device innovation
in the scope of drug project timelines?
	 •	Profiling patient populations – dos and don’ts
	Moderator: Alphons Fakler, Group Head of Risk
Management, Novartis Pharma
	Cedric Gysel, Device Engineer, Device Centre of Excellence,
Janssen
	Barry Knight, Device Program Lead, UCB Celltech
	Alexander Jung, Senior Manager, Technology and
Innovation, Drug Delivery and Devices, Boehringer Ingelheim
11.40	Large volume injections, investigation of patients
and combination product challenges
	 •	Market trends
	 •	Technical and user considerations of large volume delivery
	 •	Safelia® case study
	Adrien Tisserand, Global Category Manager,
Parenteral and CMO, Nemera
12.20	 Networking lunch Sponsored by Worrell
13.20	Considering regulatory and technical challenges
to meet specialized drug product requirements
	 •	Challenges of combination products with very small
or quite large volume applications in parenteral drug
products
		 -	Regulatory approval
		 -	Primary packaging material selection
		 -	Drug product stability and manufacturing
	 •	Potential technical solutions
	Christian Dechant, Senior Manager, Technology and
Innovation, Drug Delivery and Devices, Boehringer Ingelheim
Technology Developments for Chemical Stability
14.00	 The most suitable plastic syringe for biologics
	 •	Multilayer Plastic Syringe made of COP and oxygen
absorbing polymer
	 •	Glass-like oxygen barrier
	 •	Very low extractables
	 •	High UV Barrier
	Takuya Minezaki, Research Manager, Mitsubishi Gas Chemical
14.40	Risk mitigation strategies and documentation for
extractable, leachable and interactions in PFS
	 •	Choice of critical components for drug compatibility in PFS
	 •	Predictive tools for interactions in PFS
	 •	Relationship between extractables, simulated leachables
and leachables in PFS
	 •	Case studies on leachable assessments in pre-filled syringes
	Carsten Worsoe, Principal Scientist, CMC Analytical Support,
Novo Nordisk
15.20	 Afternoon Tea
Emerging Broader Market Trends
15.50	Challenges for Biologics Drug Products at the
interface of formulation, primary packaging and
application
	 •	The interface of formulation and pre-filled syringe:
		 -	Protein stability challenges
		 -	Device functionality challenges
	 •	The interface of formulation and application
		 -	Need for high concentration formulations
		 -	Challenges in the development and application of highly
concentrated formulations
		 -	SC volume limitations and options to overcome the need
for high concentration formulations
	Susanne Joerg, Head of Formulation Development, Lonza
16.30	Bridging Gaps in Drug Delivery Innovation:
Addressing challenges of delivering complex
biologics AND improving patient outcomes
	 •	Trends in Biologics Development
	 •	Broad array of technologies to meet the delivery needs-
vial, IV, handheld injectors, wearable injectors and novel
delivery platforms
	 •	Amgen’s Mission to serve patients
	 •	Patient centric approaches to device development-
Neulasta OnPro case study
	 •	Improving patient outcomes through increased
compliance/adherence
	Sudeshna Dutta, Senior Engineer, Advanced Device
Technology and Innovation, Amgen
17.10	 Co-Chair’s Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
■ Regulatory
■ Pharmaceutical and Biotechnology
■ Academia
■ Medical Device and Technology
CONFERENCE
ATTENDEE PROFILE 2017
Pre-Filled Syringes Europe 					 www.pre-filled-syringes.com
Day Two | Thursday 18th January 2018
Workshop Leader:
oliver valet,
Co-Founder, Rap-iD
half-Day pRe-ConfeRenCe WoRkshop B
tUesDay 16th janUaRy 2018, CopthoRne taRa hotel, lonDon, Uk
13.30 - 17.00
navigating the siliCone layeR
Workshop overview:
With increasing focus on patient satisfaction, it has become essential to
control and understand siliconization in pre-filled syringes. This comprehensive
training program will teach you how to put quality at the heart of your product
specification, and provide you with the key learning points and information
needed, for you to control and validate the quality parameters in a pre-filled
syringe.
Why you should attend:
By attending this workshop, you will be able to generate and measure accurate
information about the quantity, quality and distribution of the silicone layer
in your parenteral primary packaging, such as syringes, cartridges and vials.
Equipping you with the ability to demonstrate the value and quality of your
product in the industry.
about the Workshop leader:
Dr. oliver valet - Dr. Valet is the co-founder of rap.ID Particle Systems
GmbH, which develops manufactures and sells rapid particle
identification systems. rap.ID’s technology has combined particle
isolation, imaging analysis and spectroscopic technologies, creating
investigative tools for particle identification and characterization.
Dr. Valet has extensive experience in foreign particulate matter testing
and Root Cause investigation. He has also worked on the development of
accurate and reproducible technologies for characterising silicone oil layer
thickness, and its distribution in parenteral packaging materials.
lisa krapf - Lisa Krapf has been working as an Application Scientist
for rap.ID since 2015. She obtained her degree in Biophysics in 2008.
As a Researcher at University, she gained experience in the fields of
microscopy and spectroscopy for biological applications. at rap.ID,
she provides customer support for working with rap.ID instruments in the field of
foreign particulate testing, as well as characterizing silicone oil layer thickness.
about the organisation:
Rap.ID is the technological leader in the control of lubricant films and
identification of foreign particulate matter (FPM). In Europe, rap.ID operates
as the most preferred contract testing laboratory for FPM ID in parenteral drug
products. Rap.ID Inc. has years of invaluable experience and knowledge in
regard to customized application development and analysis services.
programme
13.30 Workshop Registration and morning Coffee
14.00 Workshop leader introduction
14.15 session one: application of silicone oil and the
siliconization process
• Different methods of silicone application; spray on
and baked on
• Results from static and dynamic siliconization processes
• Impact on parameters on baked silicone oil
• What is the difference and how does siliconization work?
14.45 session two: silicone layer characteristics
• From ‘dust test’, gravimetric extraction and force displacement
measurements to image analysis and bubble counting
• Advantages and limitations of different techniques
• What do the measurement results mean?
• Discussion
15.30 afternoon tea and networking Break
16.00 session three: layer explorer technology and results
• Technology, traceability and reproducibility
• Comparison with other siliconization measurements
• Resolution and accuracy of the measurement
• Measurement results and limitations
• what are the advantages of the state of the art lubrication
control and investigation strategy?
16.30 session four: Case studies and investigations
• Examples of silicone thickness and distribution and stability
measurement in pre-filled syringes and baked-on cartridges
• Product stability studies
• Control suppliers quality
• How can I prevent actual problems and what is the right
investigation strategy?
• Protein particle investigations
• Raman spectroscopy and image analysis of particles
• Relationship between inhomogeneous silicone oil distribution and
protein aggregation
• Breakout session; How can I measure the relationship between
silicone oil and protein aggregation in my product?
17.00 Workshop leader Closing Remarks and Close of Workshop
Workshop overview:
This workshop is aimed at anyone who needs to commission Human Factors studies (both formative and
summative) containing digital elements in the overall offering. The regulatory process for ‘traditional
HF’ (device only) is fairly well established and will be reviewed to ensure there is both a common
understanding of the current landscape and also how the landscape is changing to accommodate
more iterative and agile work streams that sit alongside. The workshop will allow participants to plan and
execute these different work streams when planning their next HF study.
Why you should attend:
For anyone starting to think about bringing digital health solutions to market, this workshop will allow you
to understand how traditional HF studies are changing and how the ‘agile’ and iterative world of digital
testing can work alongside the more structured, ‘waterfall’ world of device HF. This is key when designing
studies that comply with FDA and other regulatory bodies.
about the Workshop leader:
jaquie is Head of Digital Health at Cambridge Consultants and leads the initiative to provide
guidance and support to clients within the healthcare industry who are looking to transition their
business model to digital product and service-led innovation. Jaquie has a BSc in Applied Biology,
10 years’ experience in Molecular Biology and 15 years’ experience of Product Management
and Marketing software, hardware and digital services in the medical and life science industries.
about the organisation:
Cambridge Consultants develops breakthrough products, creates and licenses intellectual property,
and provides business consultancy in technology-critical issues for clients worldwide. For more than 50
years, the company has been helping its clients turn business opportunities into commercial successes,
whether they are launching first-to-market products, entering new markets or expanding existing markets
through the introduction of new technologies. With a team of 750 staff, including engineers, scientists,
mathematicians and designers, in offices in Cambridge (UK), Boston (USA) and Singapore, Cambridge
Consultants offers solutions across a diverse range of industries including medical technology, industrial
and consumer products, digital health, oil and gas, and wireless communications.
programme
08.30 Workshop Registration and morning
Coffee
09.00 Workshop leader introduction
09.10 overview of the Digital landscape and
fDa
• Is it a medical system or not?
• Overview of Consumer Digital systems
• Overview of Medical Digital systems
09.40 What is Ux and how is it interpreted for
‘hybrid’ systems?
• Three sub sections of UX
• How does regulated HF methodology
play with other aspects of UX?
10.30 morning Coffee and networking Break
11.00 Bringing digital into traditional hf – how
does it change the process?
• Agile vs Waterfall methodologies
• How to merge the two
• What is the delta?
11.30 Design of the Ui(s)
• ADA and WC3
12.00 validation of the digital system
• Merging methodologies
12.30 Closing Remarks and end of Workshop
ComBining ‘tRaDitional’ hUman faCtoRs With smaRt DRUg
DeliveRy DeviCes foR hyBRiD paRenteRal Development
half-Day pRe-ConfeRenCe WoRkshop a
tUesDay 16th janUaRy 2018, CopthoRne taRa hotel, lonDon, Uk
08.30 - 12.30
Workshop Leader:
jacquie finn,
Head of Digital Health,
Cambridge Consultants
Register online at www.pre-filled-syringes.com
pRoUDly sponsoReD By:
früh verpackungstechnik ag
Früh Verpackungstechnik AG is located in Switzerland and Europe’s leader for contract packaging of medical devices. We
have as well the Swiss Medic approval for secondary packaging of pharmaceuticals. Our expertise is the assembling (in ISO
class 7 clean rooms) and packaging of pre-filled syringes for sterile applications with respecting cold chain requirements. Früh
offers as well the production of pre-made packaging materials (blisters and pouches) in class 7 clean rooms. www.fruh.ch
mitsubishi gas Chemical
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. www.mgc.co.jp
nemera
Nemera is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical,
biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal,
Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in the parenteral
device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed:
Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. Safelia®, a new
generation of 2-steps auto-injector for fluid and viscous formulations. www.nemera.net
panasonic healthcare
We contribute to the wellbeing of society by creating new value for all the people who wish for better health. [In
April 2018, Panasonic Healthcare Co., Ltd will be renamed PHC Corporation] We are committed to aspiring to be
a company that continues to help customers by providing high value-added products and services through our
three core businesses, namely In Vitro Diagnostic Devices, Medical IT, and Laboratory and Medical Support Devices.
www.panasonic-healthcare.com/global
terumo pharmaceutical solutions
Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical
technology. In addition to offering our valued products, our specialized team also provides customized and dedicated
solutions designed to meet your specific requirements. www.terumo-ps.com
West pharmaceutical 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. West
is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America,
Europe, Asia and Australia. West’s 2016 net sales of $1.5 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.
www.westpharma.com
Worrell
Worrell is a global design firm that specializes in healthcare innovation and strategy. Since 1976, Worrell has served medical
device and pharmaceutical companies with expertise in ethnographic research, human factors, and design and
development programs. Working on the front lines with patients and healthcare professionals, Worrell uncovers unmet needs
to bring new drug delivery, medical device, and digital health solutions to the market. www.worrell.com
sUppoRteD By
sponsoRship anD exhiBition oppoRtUnities
smi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you 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 conference please call:
alia malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
maRketing oppoRtUnities
Want to know how you can get involved? interested in promoting your services to this market?
Contact teri arri, smi marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
pre-filled syringes europe
www.pre-filled-syringes.com
offiCial meDia paRtneRs
pRe-filleD syRinges eURope 2018
Conference: Wednesday 17th  Thursday 18th January 2018, Copthorne Tara Hotel, London, United Kingdom
Workshops: Tuesday 16th January 2018, London, UK
4 Ways to RegisteR
www.pre-filled-syringes.com
fax your booking form to +44 (0) 870 9090 712
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□ please contact me to book my hotel
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email: events@smi-online.co.uk or fax +44 (0) 870 9090 712
i cannot attend but would like to purchase access to the following Document
portal/paper copy documentation price total
□ Access to the conference documentation
on the Document Portal £499.00 + vat £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
Unique Reference number
our Reference lvp-232
eaRly BiRD
DisCoUnt
□ Book by 29th september to receive £400 off the conference price
□ Book by 31st october to receive £200 off the conference price
□ Book by 30th november to receive £100 off the conference price
Delegate Details
terms and Conditions of Booking
payment
vat
DoCUmentation
venUe Copthorne tara hotel, scarsdale place, kensington, london W8 5sy
ConfeRenCe pRiCes
i would like to attend: (Please tick as appropriate) fee total
□ Conference  2 Workshops £2697.00 + vat £3236.40
□ Conference  1 Workshop A □ B □ £2098.00 + vat £2517.60
□ Conference only £1499.00 + vat £1798.80
□ 2 Workshops £1198.00 + vat £1437.60
□ 1 Workshop only A □ B □ £599.00 + vat £718.80
pRomotional liteRatURe DistRiBUtion
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + vat £1198.80
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.

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SMi Group's 10th annual Pre-filled Syringes Europe 2018 conference & exhibition

  • 1. plUs tWo inteRaCtive half-Day pRe-ConfeRenCe WoRkshops TUESDAY 16TH JANUARY 2018, COPTHORNE TARA HOTEL, LONDON, UK B: navigating the silicone layer Workshop Leader: oliver valet, Co-Founder, Rap-iD 13.30 - 17.00 highlights in 2018: • Engage with the latest regulatory updates and guidelines for ultimate product compliance and efficiency • Discuss the emerging hot topic of combination products and benchmark against other industry-leaders • Participate in the increased focus towards digital connectivity and smart devices for improved patient adherence • Follow approaches to human factors and end-user engagement from formulation to after-market development • Witness the latest insights into the broader market trends of increased biologics attention and how to address these challenges head on ChaiRs foR 2018: • alphons fakler, Group Head Risk Management, novartis pharma • Bettine Boltres, Technical Account Manager, West pharmaceutical services keynote speakeR: • elizabeth Baker, Group Manager Licensing Division, mhRa featUReD speakeRs: • marcel mueller, Device Project Leader, novartis pharma • Cedric gysel, Staff Device Engineer, janssen • Carsten Worsoe, Principal Scientist, CMC Analytical Support, novo nordisk • vikas jaitely, Senior Manager CMC Regulatory Intelligence and Pharmaceutical Science, merck • susanne joerg, Head of Formulation Development, lonza • orla Downes, Head of Business Development Unit, Barts health pharmaceuticals • Barry knight, Device Program Lead, UCB Celltech • sudeshna Dutta Ray, Senior Engineer, Advanced Device Technology and Innovation, amgen • alexander jung, Senior Manager, Technology and Innovation, Drug Delivery and Devices, Boehringer ingelheim • Christian Dechant, Primary Packaging Director, Boehringer ingelheim SMi Presents Europe’s Leading 10th Annual Conference and Exhibition... Copthorne Tara Hotel, London, UK WORKSHOPS: 16TH CONFERENCE: 17TH - 18TH JAN 2018 Pre-Filled Syringes Europe www.pre-filled-syringes.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 aCaDemiC & gRoUp DisCoUnts availaBle @smiphaRm #pfssmi RegisteR By 29th septemBeR anD save £400 RegisteR By 31st oCtoBeR anD save £200 RegisteR By 30th novemBeR anD save £100 a: Combining ‘traditional’ human factors with smart drug delivery devices for hybrid parenteral development Workshop Leader: jacquie finn, Head of Digital Health, Cambridge Consultants 08.30 - 12.30 Unveiling emerging trends for future industry leverage sponsoReD By Copyright©WestPharmaceuticalServices
  • 2. letteR fRom the ChaiRs: Dear participants, ItiswithgreatpleasurethatwewelcomeyoutoparticipateinEurope’sleading event on Pre-Filled Syringes for its centenary year of success. We are delighted to chair this forum which has been drafted with great care to allow for the very best discussions and engagement on crucial topics for our industry. What will the future of the pharmaceutical market look like in Europe? Not only will it face unique challenges nowadays with the Brexit approaching quickly but also with the need to adapt to other trends. An increasing number of generics and biosimilars will hit the market, more and more drugs will be self- administered and a switch from blockbusters to drugs tailored to small patient groups will require adapting procedures and mindset. In this year’s conference, the patient will be in focus again. What can we do to ensure patient adherence and mitigate application errors? How can we improve our understanding of the patient experience? What are the actual challenges a patient is facing while handling our devices? These are just some of the questions the presentations and panel discussion will address and illuminate from various aspects. Besides that, latest trends in the development of both formulations and devices as well as challenges during life-cycle management will be in scope. Asallindustrytakesthesamepath,thisconferenceprovidestheidealplatform to share best practices, benefit from lessons learned and network with other experts in the field. alphons fakler, Group Head Risk Management, novartis pharma Bettine Boltres, Technical Account Manager, West pharmaceutical services 08.30 RegistRation & Coffee 09.00 Co-ChaiR’s opening RemaRks alphons fakler, Group Head Risk Management, novartis pharma Bettine Boltres, Technical Account Manager, West pharmaceutical services RegUlatoRy UpDates keynote aDDRess 09.10 latest RegUlations anD the impliCations foR the pfs inDUstRy • Overview and guidance for key legislation related to PFS • The changes ahead • Determining regulatory routes elizabeth Baker, Group Manager Licensing Division, mhRa panel DisCUssion 09.50 inDUstRy feeDBaCk on RegUlation impaCt • What has been the impact of regulations on established products? • What are your experiences with the implications of regulation on the management of difficult formulations? • How do you envisage the future of market surveillance? • How have you adapted to the regulations so far? moderator: Bettine Boltres, Technical Account Manager, West pharmaceutical services vikas jaitely, Senior Manager CMC Regulatory Intelligence and Pharmaceutical Science, merck marcel mueller, Device Project Lead, novartis pharma 10.30 moRning Coffee DRUg-DeliveRy: fRom foRmUlation to maRket 11.00 CCi testing of syRinge BaRRels at Dimensional extRemes faCing ReqUiRements of UpDateD Usp<1207> • Background • Description of test approach • Calculation and sourcing of worst case samples • Applied test method • Test results markus hemminger, Senior Engineer, f. hoffmann-la Roche* 11.40 an innovative ComBination pRoDUCt foR CaRDiology in pRe-filleD syRinge pResentations • A primer to atherosclerosis • The development of combination products for cardiovascular risk reduction • Challenges encountered in a fast-changing environment • Successful answers to global challenges marcel mueller, Device Project Leader, novartis pharma 12.20 netWoRking lUnCh sponsoReD By 13.20 impaCt of steRilization on pRotein aggRegation anD DegRaDation in a polymeR-BaseD pRe-filleD syRinge system • Importance for minimising risks of protein interaction with surfaces and materials of the container closure system to eliminate immunogenicity and ensure drug safety and efficacy • A system approach, including selection of suitable sterilization method, will be required for minimizing a risk of immunogenicity • Steam sterilization can be the preferred method of sterilization for pre-fillable syringes for use with therapeutic protein products takeuchi katsuyuki, Business Development – Global Pharmaceutical Solutions, terumo the fUtURe of DRUg DeliveRy pRoDUCts 14.00 impRoving patient oUtComes With mixeD Reality anD aRtifiCial intelligenCe teChnologies • How voice assistant technology, such as Amazon Alexa and Google Home creates opportunities to improve medication / therapy adherence and long-term patient engagement • How Microsoft Hololens can help train and engage field clinical reps, healthcare professionals and patients with drug delivery and instructions for use • Leveraging voice-enabled technology to guide patients and capture clinical trial data kai Worrell, CEO, Worrell inc. 14.40 faCilitate meaningfUl DiffeRentiation of pRoDUCts By estaBlishing a CUltURe of innovation • Case study on fostering a culture of innovation • Selected examples of how building on existing platforms allows to differentiate existing products and deliver value to the patient stefan holzner, Senior Director Head of Device Development & External Manufacturing, shire* 15.20 afteRnoon tea engaging With patient neeDs in paRenteRal DRUg DeliveRy 15.50 the path to safe injeCtion With pRe-filleD syRinges • What makes injection safe? • Different aspects regarding use of polymer syringes vs glass • Discuss the preferred closure for staked needle syringes • Drivers, statistics and legislation for safety systems • Market overview, current trends and new technologies for self-injection solutions Christa jansen-otten, Director, Product Management, West pharmaceutical services 16.30 the valUe of a hUman-CentReD appRoaCh to phaRmaCeUtiCal DeliveRy systems • What is Human-Centred design and why does it matter? • Meaningful innovation driven by Human-Centred Insights • Examples: Training materials and device platforms Cedric gysel, Device Engineer, Device Centre of Excellence, janssen 17.10 Co-ChaiR’s Closing RemaRks anD Close of Day one Register online at www.pre-filled-syringes.com UpComing events foR the DiaRy: pRe-filleD syRinges east Coast SHERATON BOSTON HOTEL, BOSTON, MA, USA 11TH - 12TH APRIL 2018 pRe-filleD syRinges West Coast CROWNE PLAZA, SAN DIEGO, CA, USA 4TH - 5TH JUNE 2018 pre-filled syringes europe www.pre-filled-syringes.com Day one | WeDnesDay 17th janUaRy 2018 *Subject to confirmation
  • 3. 08.30 Registration & Coffee 09.00 Co-Chair’s Opening Remarks Alphons Fakler, Group Head Risk Management, Novartis Pharma Bettine Boltres, Technical Account Manager, West Pharmaceutical Services Usability from Human Factors Approaches KEYNOTE ADDRESS 09.10 Overcoming regulatory challenges within the PFS and auto-injector development and lifecycle management • Current regulatory requirements within the EU and US framework • Overcoming regulatory challenges to support global development of pre-filled syringe platform technology and technological advancement • Documentations requirements for MA filing • Handling of regulatory aspects of Post-Approval Change related to pre-filled syringes within product lifecycle management - European perspective Vikas Jaitely, Senior Manager CMC Regulatory Intelligence and Pharmaceutical Science, Merck 09.50 Formulation Viscosity – Aseptic Manufacturing Challenges, Human factor and patient need considerations • Challenges faced during aseptic filling of viscous formulations in pre-filled syringe and mitigating those challenges • Human Factors – Human-Centered Design • Common user problems Orla Downes, Head of Business Development Unit, Barts Health Pharmaceuticals 10.30 Morning Coffee PANEL DISCUSSION 11.00 Benefits and pitfalls of drug delivery devices from auto-injectors to pre-filled syringes • What do we prioritise: Cognitive usability or physical ergonomics? • How can we engage more with Human-Centred design in the development of new devices? • How should we overcome the issues of device innovation in the scope of drug project timelines? • Profiling patient populations – dos and don’ts Moderator: Alphons Fakler, Group Head of Risk Management, Novartis Pharma Cedric Gysel, Device Engineer, Device Centre of Excellence, Janssen Barry Knight, Device Program Lead, UCB Celltech Alexander Jung, Senior Manager, Technology and Innovation, Drug Delivery and Devices, Boehringer Ingelheim 11.40 Large volume injections, investigation of patients and combination product challenges • Market trends • Technical and user considerations of large volume delivery • Safelia® case study Adrien Tisserand, Global Category Manager, Parenteral and CMO, Nemera 12.20 Networking lunch Sponsored by Worrell 13.20 Considering regulatory and technical challenges to meet specialized drug product requirements • Challenges of combination products with very small or quite large volume applications in parenteral drug products - Regulatory approval - Primary packaging material selection - Drug product stability and manufacturing • Potential technical solutions Christian Dechant, Senior Manager, Technology and Innovation, Drug Delivery and Devices, Boehringer Ingelheim Technology Developments for Chemical Stability 14.00 The most suitable plastic syringe for biologics • Multilayer Plastic Syringe made of COP and oxygen absorbing polymer • Glass-like oxygen barrier • Very low extractables • High UV Barrier Takuya Minezaki, Research Manager, Mitsubishi Gas Chemical 14.40 Risk mitigation strategies and documentation for extractable, leachable and interactions in PFS • Choice of critical components for drug compatibility in PFS • Predictive tools for interactions in PFS • Relationship between extractables, simulated leachables and leachables in PFS • Case studies on leachable assessments in pre-filled syringes Carsten Worsoe, Principal Scientist, CMC Analytical Support, Novo Nordisk 15.20 Afternoon Tea Emerging Broader Market Trends 15.50 Challenges for Biologics Drug Products at the interface of formulation, primary packaging and application • The interface of formulation and pre-filled syringe: - Protein stability challenges - Device functionality challenges • The interface of formulation and application - Need for high concentration formulations - Challenges in the development and application of highly concentrated formulations - SC volume limitations and options to overcome the need for high concentration formulations Susanne Joerg, Head of Formulation Development, Lonza 16.30 Bridging Gaps in Drug Delivery Innovation: Addressing challenges of delivering complex biologics AND improving patient outcomes • Trends in Biologics Development • Broad array of technologies to meet the delivery needs- vial, IV, handheld injectors, wearable injectors and novel delivery platforms • Amgen’s Mission to serve patients • Patient centric approaches to device development- Neulasta OnPro case study • Improving patient outcomes through increased compliance/adherence Sudeshna Dutta, Senior Engineer, Advanced Device Technology and Innovation, Amgen 17.10 Co-Chair’s Closing Remarks and Close of Day Two Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 ■ Regulatory ■ Pharmaceutical and Biotechnology ■ Academia ■ Medical Device and Technology CONFERENCE ATTENDEE PROFILE 2017 Pre-Filled Syringes Europe www.pre-filled-syringes.com Day Two | Thursday 18th January 2018
  • 4. Workshop Leader: oliver valet, Co-Founder, Rap-iD half-Day pRe-ConfeRenCe WoRkshop B tUesDay 16th janUaRy 2018, CopthoRne taRa hotel, lonDon, Uk 13.30 - 17.00 navigating the siliCone layeR Workshop overview: With increasing focus on patient satisfaction, it has become essential to control and understand siliconization in pre-filled syringes. This comprehensive training program will teach you how to put quality at the heart of your product specification, and provide you with the key learning points and information needed, for you to control and validate the quality parameters in a pre-filled syringe. Why you should attend: By attending this workshop, you will be able to generate and measure accurate information about the quantity, quality and distribution of the silicone layer in your parenteral primary packaging, such as syringes, cartridges and vials. Equipping you with the ability to demonstrate the value and quality of your product in the industry. about the Workshop leader: Dr. oliver valet - Dr. Valet is the co-founder of rap.ID Particle Systems GmbH, which develops manufactures and sells rapid particle identification systems. rap.ID’s technology has combined particle isolation, imaging analysis and spectroscopic technologies, creating investigative tools for particle identification and characterization. Dr. Valet has extensive experience in foreign particulate matter testing and Root Cause investigation. He has also worked on the development of accurate and reproducible technologies for characterising silicone oil layer thickness, and its distribution in parenteral packaging materials. lisa krapf - Lisa Krapf has been working as an Application Scientist for rap.ID since 2015. She obtained her degree in Biophysics in 2008. As a Researcher at University, she gained experience in the fields of microscopy and spectroscopy for biological applications. at rap.ID, she provides customer support for working with rap.ID instruments in the field of foreign particulate testing, as well as characterizing silicone oil layer thickness. about the organisation: Rap.ID is the technological leader in the control of lubricant films and identification of foreign particulate matter (FPM). In Europe, rap.ID operates as the most preferred contract testing laboratory for FPM ID in parenteral drug products. Rap.ID Inc. has years of invaluable experience and knowledge in regard to customized application development and analysis services. programme 13.30 Workshop Registration and morning Coffee 14.00 Workshop leader introduction 14.15 session one: application of silicone oil and the siliconization process • Different methods of silicone application; spray on and baked on • Results from static and dynamic siliconization processes • Impact on parameters on baked silicone oil • What is the difference and how does siliconization work? 14.45 session two: silicone layer characteristics • From ‘dust test’, gravimetric extraction and force displacement measurements to image analysis and bubble counting • Advantages and limitations of different techniques • What do the measurement results mean? • Discussion 15.30 afternoon tea and networking Break 16.00 session three: layer explorer technology and results • Technology, traceability and reproducibility • Comparison with other siliconization measurements • Resolution and accuracy of the measurement • Measurement results and limitations • what are the advantages of the state of the art lubrication control and investigation strategy? 16.30 session four: Case studies and investigations • Examples of silicone thickness and distribution and stability measurement in pre-filled syringes and baked-on cartridges • Product stability studies • Control suppliers quality • How can I prevent actual problems and what is the right investigation strategy? • Protein particle investigations • Raman spectroscopy and image analysis of particles • Relationship between inhomogeneous silicone oil distribution and protein aggregation • Breakout session; How can I measure the relationship between silicone oil and protein aggregation in my product? 17.00 Workshop leader Closing Remarks and Close of Workshop Workshop overview: This workshop is aimed at anyone who needs to commission Human Factors studies (both formative and summative) containing digital elements in the overall offering. The regulatory process for ‘traditional HF’ (device only) is fairly well established and will be reviewed to ensure there is both a common understanding of the current landscape and also how the landscape is changing to accommodate more iterative and agile work streams that sit alongside. The workshop will allow participants to plan and execute these different work streams when planning their next HF study. Why you should attend: For anyone starting to think about bringing digital health solutions to market, this workshop will allow you to understand how traditional HF studies are changing and how the ‘agile’ and iterative world of digital testing can work alongside the more structured, ‘waterfall’ world of device HF. This is key when designing studies that comply with FDA and other regulatory bodies. about the Workshop leader: jaquie is Head of Digital Health at Cambridge Consultants and leads the initiative to provide guidance and support to clients within the healthcare industry who are looking to transition their business model to digital product and service-led innovation. Jaquie has a BSc in Applied Biology, 10 years’ experience in Molecular Biology and 15 years’ experience of Product Management and Marketing software, hardware and digital services in the medical and life science industries. about the organisation: Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 50 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of 750 staff, including engineers, scientists, mathematicians and designers, in offices in Cambridge (UK), Boston (USA) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, digital health, oil and gas, and wireless communications. programme 08.30 Workshop Registration and morning Coffee 09.00 Workshop leader introduction 09.10 overview of the Digital landscape and fDa • Is it a medical system or not? • Overview of Consumer Digital systems • Overview of Medical Digital systems 09.40 What is Ux and how is it interpreted for ‘hybrid’ systems? • Three sub sections of UX • How does regulated HF methodology play with other aspects of UX? 10.30 morning Coffee and networking Break 11.00 Bringing digital into traditional hf – how does it change the process? • Agile vs Waterfall methodologies • How to merge the two • What is the delta? 11.30 Design of the Ui(s) • ADA and WC3 12.00 validation of the digital system • Merging methodologies 12.30 Closing Remarks and end of Workshop ComBining ‘tRaDitional’ hUman faCtoRs With smaRt DRUg DeliveRy DeviCes foR hyBRiD paRenteRal Development half-Day pRe-ConfeRenCe WoRkshop a tUesDay 16th janUaRy 2018, CopthoRne taRa hotel, lonDon, Uk 08.30 - 12.30 Workshop Leader: jacquie finn, Head of Digital Health, Cambridge Consultants Register online at www.pre-filled-syringes.com
  • 5. pRoUDly sponsoReD By: früh verpackungstechnik ag Früh Verpackungstechnik AG is located in Switzerland and Europe’s leader for contract packaging of medical devices. We have as well the Swiss Medic approval for secondary packaging of pharmaceuticals. Our expertise is the assembling (in ISO class 7 clean rooms) and packaging of pre-filled syringes for sterile applications with respecting cold chain requirements. Früh offers as well the production of pre-made packaging materials (blisters and pouches) in class 7 clean rooms. www.fruh.ch mitsubishi gas Chemical 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. www.mgc.co.jp nemera Nemera is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical, biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations. www.nemera.net panasonic healthcare We contribute to the wellbeing of society by creating new value for all the people who wish for better health. [In April 2018, Panasonic Healthcare Co., Ltd will be renamed PHC Corporation] We are committed to aspiring to be a company that continues to help customers by providing high value-added products and services through our three core businesses, namely In Vitro Diagnostic Devices, Medical IT, and Laboratory and Medical Support Devices. www.panasonic-healthcare.com/global terumo pharmaceutical solutions Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical technology. In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed to meet your specific requirements. www.terumo-ps.com West pharmaceutical 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. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West’s 2016 net sales of $1.5 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. www.westpharma.com Worrell Worrell is a global design firm that specializes in healthcare innovation and strategy. Since 1976, Worrell has served medical device and pharmaceutical companies with expertise in ethnographic research, human factors, and design and development programs. Working on the front lines with patients and healthcare professionals, Worrell uncovers unmet needs to bring new drug delivery, medical device, and digital health solutions to the market. www.worrell.com sUppoRteD By sponsoRship anD exhiBition oppoRtUnities smi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you 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 conference please call: alia malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk maRketing oppoRtUnities Want to know how you can get involved? interested in promoting your services to this market? Contact teri arri, smi marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk pre-filled syringes europe www.pre-filled-syringes.com offiCial meDia paRtneRs
  • 6. pRe-filleD syRinges eURope 2018 Conference: Wednesday 17th Thursday 18th January 2018, Copthorne Tara Hotel, London, United Kingdom Workshops: Tuesday 16th January 2018, London, UK 4 Ways to RegisteR www.pre-filled-syringes.com 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, Ground First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK Please complete fully and clearly in capital letters. Please photocopy for additional delegates. title: forename: surname: job title: Department/Division: Company/organisation: email: Company vat number: address: town/City: post/zip Code: Country: Direct tel: Direct fax: mobile: switchboard: signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. aCCoUnts Dept title: forename: surname: email: address (if different from above): town/City: post/zip Code: Country: Direct tel: Direct fax: payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. 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We cannot accept cancellations of orders placed forDocumentationortheDocumentPortalasthesearereproducedspecificallytoorder.Ifwehave to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Data protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act1998andwemayusethistocontactyoubytelephone,fax,postoremailtotellyouaboutother products and services. Unless you tick here □ we may also share your data with third parties offering complementary products or services. If you have any queries or want to update any of the data that we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URn as detailed above your address on the attached letter. 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VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. ______________________________________________________________________________________ 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 □ please contact me to book my hotel alternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712 i cannot attend but would like to purchase access to the following Document portal/paper copy documentation price total □ Access to the conference documentation on the Document Portal £499.00 + vat £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) Unique Reference number our Reference lvp-232 eaRly BiRD DisCoUnt □ Book by 29th september to receive £400 off the conference price □ Book by 31st october to receive £200 off the conference price □ Book by 30th november to receive £100 off the conference price Delegate Details terms and Conditions of Booking payment vat DoCUmentation venUe Copthorne tara hotel, scarsdale place, kensington, london W8 5sy ConfeRenCe pRiCes i would like to attend: (Please tick as appropriate) fee total □ Conference 2 Workshops £2697.00 + vat £3236.40 □ Conference 1 Workshop A □ B □ £2098.00 + vat £2517.60 □ Conference only £1499.00 + vat £1798.80 □ 2 Workshops £1198.00 + vat £1437.60 □ 1 Workshop only A □ B □ £599.00 + vat £718.80 pRomotional liteRatURe DistRiBUtion □ Distribution of your company’s promotional literature to all conference attendees £999.00 + vat £1198.80 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. 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