S M i P R E S E N T S T H E 5 T H A N N U A L

EUROPEAN PRE-FILLED SYRINGES

"Brilliant. Complicated technology explained well”Teva Pharmaceuticals

www.pre-filled-syringes.comRegister online or alternatively fax your registration to

+44 (0) 870 9090 712 or call +44 (0) 870 9090 711

28TH - 29TH JANUARY 2013 | COPTHORNE TARA HOTEL, LONDON, UK

E U R O P E ' S L E A D I N G P R E - F I L L E D S Y R I N G E S E V E N T

Sponsored by

KEY SPEAKERS INCLUDE:• Advait Badkar, Associate Research Fellow,

Pfizer• Karoline Bechtold-Peters, Head, Clinical

Manufacturing, Roche• Patrick Garidel, Head of Pharmaceutical Basic

Development, Boehringer-Ingelheim• Carston Worsoe, Principal Scientist, Novo

Nordisk• Jasdeep Singh, Head of Pharmacy

Manufacturing, Royal London Hospital• Richard Hart, Pharma Partner Executive,

Baxter Healthcare• Violeta Gabrijelcic, Head Global

Pharmaceutical and Device Development,Sandoz

• Morag Bratby, Pharmaceutical Assessor,MHRA

KEY REASONS TO ATTEND:Explore the challenges for the development of HCLF biologics withkey industry professionals

Consider the effects of leachables and extractables and evaluatinginteractions between formulation and containers

Develop your understanding of regulatory compliance frompharmaceutical companies and the MHRA

Hear from leading healthcare professionals on the growing use ofpre-filled syringes at the patient ‘front line’

Streamline the filling and closing process by exploring facility designstrategies and syringe development line techniques

Discuss the latest in vendor procurement and outsourcing strategies

Network with and learn from key industry professionals, leadingacademics and healthcare representatives

PLUS TWO INTERACTIVE POST CONFERENCE WORKSHOPS

Workshop A: The Future of Self-injection:Where do we want to be?

8.30am - 12.30pm30th January 2013, Copthorne Tara Hotel, London, UK

Workshop Leaders: Martin Bontoft, Head of DesignResearch and Julian Dixon, Director of Human Factors,

Team Consulting

Workshop B: Safety Issues within Pre-filled Syringes

1.30pm - 5.30pm30th January 2013, Copthorne Tara Hotel, London, UK

Workshop Leaders: Simon Cohen, Director, Innovate UK

Early Bird Discounts: BOOK BYSEPTEMBER 28THSAVE £300 BOOK BYOCTOBER 31STSAVE £100

28TH - 29TH JANUARY 2013 | COPTHORNE TARA HOTEL, LONDON, UK

NEW FOR 2013: EVENING DINNER AT THE GILGAMESH RESTAURANTNEW FOR 2013: EVENING DINNER AT THE GILGAMESH RESTAURANT

Register online at www.pre-filled-syringes.com • Alternatively fa

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8.30 REGISTRATION & COFFEE

9.00 Chairman's opening remarksAdvait Badkar, Associate Research Fellow, Pfizer

PRE-FILLED SYRINGE FORMULATIONS

9.10 Development Considerations for Biologics as Pre-FilledSyringe Products: A QbD approach• Quality Attributes for Pre-filled syringe products that are

of concern• Component Selection and Risk Assessment• Co-development with Component Manufacture• Taking these lessons and making immediate

improvementsAdvait Badkar, Associate Research Fellow, Pfizer

9.50 PFS Developments for Biotechs• Prefilled syringe market overview• Patient, regulatory and operational

excellence trends for the biotech• Injectable market• Development of new biotech prefillable systems answering

unmet needsNicolas Morais, Product Manager, Europe, PrefillableSyringes, BD Medical

10.30 MORNING COFFEE

11.00 Extractables and Leachable investigations anddocumentation for pre-filled syringes • Risk assessment for extractables and leachabes in PFS • Optimal study for PFS - extractable, simulated or leachable

study ? • Experiences with glass vs. plastic PFS• Case studies on extractables and leachables in PFS systems Carsten Worsoe, Principal Scientist, Novo Nordisk

11.40 Development of pre-filled syringes for high concentratedliquid protein formulations• Challenges for the development of HCLF biologics• Interactions with primary packaging• Stability issues• Medical requirements and applicationPatrick Garidel, Associate Director Protein Science,Boehringer Ingelheim

12.20 NETWORKING LUNCH

13.40 Leachables and Extractables in Pre-Filled Syringes• Review of current guidance available• Reducing, monitoring and controlling interactions• Non-invasive methods of detection• Effects of material selections• Performing controlled extraction studiesStephen Barat, Senior Director, Toxicology and Operations,Forest Laboratories

14.10 Q & A Discussion with the Morning Session Speakers

14.30 AFTERNOON TEA

PRIMARY PACKAGING DEVELOPMENTS

14.50 Daikyo Crystal Zenith® Prefillable syringe Systems: A Superior Containment Alternative over Glass Syringes• The unique properties of Daikyo Crystal

Zentih prefillable syringe systems• Discussion into the associated processing requirements

to fill and finish these unique systems• Exponential advantages for the safety and stability of high

value biopharmaceutical drug productsNicolas Brandes, Director Strategic Marketing Daikyo CrystalZenith Products, West Pharma

15.30 Interactions between formulation components and container• Reducing extractables and leachables in pre-filled syringes

by collaborations with packaging design• Interactions with primary packaging• Techniques for inspection• Differences between interactions in glass and plastic

syringes Sandipan Sinha, Prinicpal Scientist, Pfizer

16.00 Proven Glass Coding Technology allows for full Traceability in Production and the Supply Chain • Total visibility of the manufacturing process

through batch record/ pedigree on item level • Preventing of mix-ups between production lots even of

unlabeled containers • Method to support filling lines clearing after product change • Identifying a single item in the after sales supply chain to

authenticate its original provenance to fight against productpiracy.

Carmen Heiter, Product Management, Syringes, Schott

16.40 Primary container developments; Glass V Plastic• Developments in glass syringes; stability and permeability• Advanced processing and inspections of glass containers• New manufacturing techniques of polymer based containers• Filling capability of polymer syringesModerator:Martin Bontoft, Head of Design Research, Team ConsultingPanelist:Patrick Garidel, Associate Director Protein Science,Boehringer Ingelheim and Advait Badkar, Associate ResearchFellow, Pfizer

17.10 Chairman’s Closing Remarks

19.00 Evening Reception and DinnerAll attendees and speakers are invited to join us for a formal dinner. Transport will be provided at 19.00 from the conference hotel

Very informative with a great mix of speakers“ Sanofi-Aventis

New for 2013: Evening Dinner at the Gilgamesh RestaurantSMi Group invites you to join them for a post conference dinner reception following the end of the first day. Dinner will be held atGilgamesh Restaurant and Bar where you will have the extended opportunity to network with industry professionals. Jumpaboard a traditional red london bus at the hotel at 7.00pm for a real London experience. Leave Pre-Filled Syringes 2013 havingforged new working relationships and strengthened your current ones.

The Gilgamesh Restaurant and Bar combines history with elements of contempory design and modern art to make one of themost visually stunning venues in central London. In the Babylon Bar you will experience some of the finest pan-Asian cuisineprepared by award winning chefs. Dine, drink and socialize in jaw dropping surrounds. A truly unforgettable experience.

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ax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

"Very interesting perspectives on PFS changes” Abbott

Supported by

8.30 REGISTRATION & COFFEE

9.00 Chairman’s Opening RemarksPatrick Garidel, Associate Director Protein Science,Boehringer Ingelheim

FILLING, FINISHING & FACILITY DESIGN

9.10 Challenges and solutions in fill and finishing lines• The importance of flexibility in filling operations• Potential strategies to reduce costs and speed up processes• Dual-chamber syringes• Meeting deadline, budget and quality requirementsTobias Posset, Head of Production Support, Roche

9.40 Secondary Packaging; Hero or villain of the PFS world? An overview to PFS Secondary Packaging machinery• Relationship to filling lines• Current status of secondary packaging machinery• Current issues for the handling of filled syringes• Relationship to tertiary packagingDale Charlton, Business Development Director, Optima

10.20 MORNING COFFEE

10.50 Validation and Qualification of a cRABS Clinical Supplies Line• Review of restricted access barrier systems• Obtaining a higher level of assurance for aseptic filling

compared to cleanroom processes• Industrial scale production lines• Combination filling stationsKaroline Bechtold-Peters, Head, Clinical Manufacturing, Roche

11.20 Silicone layer control thickness and protein aggregation in prefilled syringes• Linking the influence of siliconisation

parameters and the silicone agglomeration behaviour of the protein based drug

• Enabling the understanding of the siliconization process inorder to minimize silicone induced issues for developmentand manufacturing

• Considering issues related to the interaction of silicone oiland protein based formulations

• Investigating these interactions by image directed particleRaman spectroscopic analysis equipment (SPE)

Oliver Valet, Managing Director, rap.ID GmbH

12.00 Q & A Discussion with Filling and Finishing Session Speakers

12.20 NETWORKING LUNCH

DEVICE DESIGN AND PATIENT SAFETY APPROACHES

13.30 Formulation and Pre-filled Syringe Development forBiosimilars - Sandoz Experience• What are the common obstacles in development?• Specifics in biosimilar syringe development• Focus on Sandoz Case StudiesVioleta Gabrijelcic, Head Global Pharmaceutical and DeviceDevelopment, Sandoz

14.00 The role of pre-filled syringes in patient safety• Current trends in parenteral therapy• Intravenous medication safety• New international recommendations and regulations• Advantages of pre-filled syringes• Barriers to the introduction of pre-filled syringesDavid Whitaker, Consultant Anaesthetist, Manchester RoyalInfirmary

14.30 Safety Devices for Self-injection Drugs• Safety devices as a primary choice

to be added to pre-filled syringes to meet anit-needlestick legislation aroundthe globe

• Currently a growing number of biotech drugs in pharma’spipeline that require self-injection device to satisfy patients’needs and handle new drug properties eg. Higher viscosities

• How was the design of a clinically proven safety deviceadapted to meet those new requirements

Alexander Jaksch, VP of Business Development andMarketing, Safety Syringes, Inc

15.10 Reducing contamination and medical errors with PFS in the acute care environment and address the need for compatibility with syringe pumps • BD response: New generation of polymer large size PFS • Presentation of the solution: superior Materials (CCP

&rubber), innovation with patented luer lock • Seamless transition by design: acceptance in syringe pumps • Technical performance and pumps requirements: tests on

gliding, clinical study on product performance • Human Factors: Preliminary results of the clinical study on

user acceptance figures and product preference• Platform for new generation of plastic products at BD, for

applications in other therapeutical classes Dragana Cvijanovic, Product Manager, BD Medical

15.50 AFTERNOON TEA

REGULATORY & COMMERCIALISATION TRENDS

16.10 Regulatory Aspects of Pre filled Syringes in Europe • Pre-filled syringe: medicinal product or medical device • Borderline Examples • Auto-injectors • Module 3: Quality - including special focus on the

Manufacturing Process, Container Closure aspects • Agency feedback: Licensing • the Regulatory Horizon • Future MAA trends: Rapid Micro MethodsMorag Bratby, Pharmaceutical Assessor, MHRA

16.40 Pre-filled Syringes: An NHS Perspective• Manufacturing of pre-filled syringes as ‘specials’• Problems at the coal face – how can we overcome then?• Patient perspectives• Lessons pharma can learn from the NHSJasdeep Singh, Head of Pharmacy Manufacturing, RoyalLondon Hospital

17.10 Manufacturing pre-filled syringes with a contractmanufacturing partner. • Finding and selecting a partner • Contracting for success • Overcoming challenges • Achieving excellent outcomes Richard Hart, Pharma Partner Executive, Baxter Healthcare

17.40 Chairman’s Closing Remarks and End of Day Two

Want to know how to get involved? Interested in promoting your services to this market? Contact Margaret Mugema on +44 (0) 207 827 6072 or email: mmugema@smi-online.co.uk

Official Media Partner

PLUS TWO INTERACTIVE POST–CONFERENCE WORKSHOPS WEDNESDAY 30TH JANUARY 2013, COPTHORNE TARA HOTEL, LONDON, UK

Workshop A: The Future of Self-injection: Where do we want to be?

8.30am - 12.30pmWorkshop Leader: Martin Bontoft, Head of Design Researchand Julian Dixon, Director of Human Factors, Team Consulting

OverviewWe have seen an explosion of attention to human factors (HF) indrug delivery device development. This has been the era ofusability, marked by a focus on the effectiveness and safety ofdevices in the hands of users. By focusing on case studies fromadjacent fields, this interactive workshop will discuss andshowcase the new methods and mindset that need to adopted inorder to meet our ambitions for self-injection.

Timetable

8.30 Registration & Coffee

9.00 Welcome & Introductions

9.15 The landscape and current trends in self-injection

9.45 How to ‘do’ human factors engineering in line withregulatory requirements

10.15 Beyond validation: desirability, advocacy, adherence

10.45 Mindsets and methodologies for researching thepatient experience

11.15 Morning Coffee

11.30 The customer journey: the path to participation

12.00 What constraints have we imposed on our user appealaspirations by the technology we’ve selected?

12.30 End of Workshop

About Team Consulting:We are recognised globally as experts in the design anddevelopment of medical devices. That’s all we do and we areproud of this focus. It enables us to deliver real insight andexpertise to our clients.Commercially successful products needto be safe, easy to use and ultimately make people better. Ourclients like our approach, which combines design, humanfactors, science and engineering from inspiration right throughto industrialisation.

Workshop B: Safety Issues within Pre-filled Syringes

1.30pm - 5.30pmWorkshop Leader: Simon Cohen, Director, Innovate UK

OverviewThis unique masterclass will focus on the latest developments inpatient safety in Pre-Filled Syringe development and will providean insight into alternative forms of risk. Led by the expertise andexperience of Simon Cohen, Director at Innovate UK thisworkshop will present attendees with an in-depth view into therisks associated with Pre-Filled Syringes and evaluating needlestick injury and splash risk.

Timetable

13.30 Registration & Coffee

14.00 Welcome & Introductions

14.10 Overview into Needle Stick Injury Risk• Current needle safety devices that are available• Comparing Automated and Table-Top Devices

14.45 Evaluating alternative forms of risk• Case Study Focus Session

15.45 Afternoon Tea 16.00 Investigation into Splatter Risk for Pre-Filled Syringes

• Developing splatter trials• Discussing Chemical and Cross-Infection Hazards

17.00 Discussion Session17.30 Close of Workshop

About Simon Cohen, Director, Innovate UKSimon has worked both in the NHS and private practicespecialising in the prevention and treatment of sports injurythrough gait analysis and biomechanics. He joined Pfizerworking as an NHS liaison specialist before continuing hiscareer in The Pharmaceutical Sector in various sales, marketingand NHS liaison roles. Simon is one of the founders of InnovateUK Ltd, alongside a number of working Doctors and aninternational lawyer. The aim for the company is to provide aservice to both The Pharmaceutical Industry and the NHS inquick turn round innovative device solutions. Their ability to turna basic idea into a finished prototype within a two-week periodhas won them a number of key customers within the sector, andhas continued to grow their portfolio of innovative solutions. Inparticular, within the safety market, in this field. Simon has alsoworked as a support for lobby groups within The EuropeanParliament.

New for 2012: SMi Event CommunitiesSMi Group is a global events business specialising in business tobusiness conferences, workshops and masterclasses.

We successfully create and run 250 events every year across 6sectors including Defence and Security, Energy and Utilities,Finance and Pharmaceuticals. We believe in bringing togetherthe most knowledgeable experts from across the globe in eachsector to learn, engage, share and network be it in London,Paris or Singapore.

To further enhance the SMi experience, we have launched ourvery own SMi Event Communities. These will be exclusive,private and secure communities in which our clients will learn,

share, engage and network. The SMi Event Communities willbuild and expand your experience beyond the conference,workshop or Masterclass you attend. Not just another "socialnetwork”, SMi’s Event Communities have been specificallydesigned around the needs of our delegates, speakers andsponsors, allowing all of our clients to foster longer termrelationships with all of the other attendees beyond the threeday event for year round engagement.

To take part all you need to do is register for this event.

SMi Group CommunitiesLearn Engage Share Network

Innovate UK

European Pre-Filled Syringes

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to

complement your company's marketing strategy. Should you wish to join the increasing numberof companies benefiting from sponsoring our conferences please call: Alia Malick,

SMi Sponsorship on +44 (0)20 7827 6168 or email: amalick@smi-online.co.uk

2013 SponsorsBD Medical Pharmaceutical Systems is a worldwide leader in supplying the pharmaceuticalindustry with quality drug delivery systems and safety-engineered devices. Our cutting-edgedelivery systems are customizable to meet patient needs, are market tested and are manufacturedto meet the high quality standards that our customers expect. BD Medical - PharmaceuticalSystems provides a comprehensive range of prefillable injection systems using clinically provenproducts that help deliver enhanced drug or end-user benefits and results, and access toinformation and distribution networks worldwide. For years we have also been one of the mostactive promoters of healthcare worker safety. www.bd.com

OPTIMA pharma with the long established brands of inova, Kugler, Klee and Metall + Plasticisolation technology offer a comprehensive, cutting-edge range of products and services inpharmaceutical fill / finish. This includes the filling and packaging of pharmaceutical liquids andpowders in syringes, vials, infusion bottles etc., as well as freeze drying systems and automaticloading / unloading systems. Turnkey production and packaging lines for medical / pharmaceuticalproducts and project management of such complex projects complete with global production /service capabilities compliments the portfolio and offering from OPTIMA pharma. www.optima-pharma.com

rap.ID provides compliant solutions for the control of silicone and other lubricants (i.e. thicknessand distribution) in pre-filled syringes. rap.ID also offers services providing foreign particleidentification. Latest invention is the SPE metal.ID+raman.ID. With this tool any user identifiesforeign particulate matter with a unique speed and high power of recognition. www.rap-id.com

Safety Syringes, Inc. (SSI) has established itself as the market leader in safety devices for prefilledglass syringes and the preferred partner of the world’s leading pharmaceutical companies. With astrong core competency in needlestick safety devices for prefilled glass syringes, SSI will continueto lead the expanding prefilled syringe market with solutions that reduce the costs of meetingincreasingly stringent anti-needlestick legislation. www.safetysyringes.com

SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of glass tubing andprimary packaging for the pharmaceutical industry. We provide our customers quality solutionswhile meeting their highest demands with our material expertise, specialized analytical labservices, and a broad product portfolio; including, syringes, cartridges, vials, ampoules, andspecial articles made of glass and COC polymer. With four glass tubing production sites andseventeen sites for pharmaceutical packaging spread over four continents, we offer safe supplyand local service. Our state-of-the-art production facilities and our products comply with thehighest international quality standards for pharmaceutical needs. www.schott.com

West Pharmaceutical Services is a global leader in providing solutions for injectable drugadministration. The products West makes and the services the company provides help improvehealth care for people around the globe.West’s innovative system, device and component solutionshelp improve the safety and administration of injectable drugs. West’s proprietary materialsscience, formulation research and manufacturing technologies advance the quality, therapeuticvalue, development speed and rapid market availability of pharmaceuticals, biologics andvaccines. West’s customers include the world’s leading pharmaceutical, biopharmaceutical andmedical device companies. West supports its customers with sales, manufacturing, customersupport and research and development from 50 locations in North and South America, Europe,Asia and Australia. www.westpharma.com

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

www.pre-filled-syringes.com POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk

Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then credit carddetails will be requested and payment taken before entry to the event. Bookings within 7 days ofevent require payment on booking. Access to the Document Portal will not be given until paymenthas been received.

Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate.

Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge,providing that cancellation is made in writing and received at least 28 days prior to the start of theevent. Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unable toattend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther 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 ProtectionAct 1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third partiesoffering complementary products or services. If you have any queries or want to update any of thedata that we hold then please contact our Database Manager databasemanager@smi-online.co.ukor visit our website www.smi-online.co.uk/updates quoting the URN as detailed above youraddress on the attached letter.

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Payment must be made to SMi Group Ltd, and received before the event, by one of thefollowing methods quoting reference P-056 and the delegate’s name. Bookings made within7 days of the event require payment on booking, methods of payment are below. Pleaseindicate method of payment:□ UK BACS Sort Code 300009, Account 00936418□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU

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DOCUMENTATIONI cannot attend but would like to purchase access to the following DocumentPortal/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)

PAYMENT

VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SR

□ Please contact me to book my hotelAlternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712

□ Book by 28th September 2012 to receive a £300 off the conference price□ Book by 31st October 2012 to receive a £100 off the conference price

EARLY BIRDDISCOUNT

CONFERENCE PRICES

EUROPEAN PRE-FILLED SYRINGES MONDAY 28TH & TUESDAY 29TH JANUARY 2013, COPTHORNE TARA HOTEL, LONDON, UK WORKSHOPS: WEDNESDAY 30TH JANUARY, 2013, LONDON

4 WAYS TO REGISTER

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

www.pre-filled-syringes.com POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

I would like to attend: (Please tick as appropriate) Fee Total□ Conference & 2 Workshops: £2797.00 + VAT £3356.40□ Conference & 1 Workshop: £2198.00 + VAT £2637.60□ Conference Only: £1599.00 + VAT £1918.80□ 1 Workshop Only: £599.00 + VAT £718.80□ 2 Workshops Only: £1198.00 + VAT £1437.60Workshop A □ Workshop B □First 25 Pharmaceutical Companies□ Conference + 2 Workshops: £2097.00 + VAT £2516.40□ Conference + 1 Workshop: £1498.00 + VAT £1797.60□ Conference Only: £899.00 + VAT £1078.80Workshop A □ Workshop B □REGISTRATION INCLUDES FREE ATTENDANCE AT (PLEASE TICK)□ End of Day 1 Evening Dinner at Gilgamesh Restaurant and Bar (28th January)PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional

literature to all conference attendees £999.00 + VAT £1198.80GROUP DISCOUNTS AVAILABLE

The conference fee includes refreshments, lunch, conference papers and access to the Document Portal containing all of the presentations.

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on DocumentPortal and Literature Distribution for all UK customers and for those EU customers not supplying a registration number for their own country here: ______________________________________