Transcript
Page 1: SMi Group's 2nd annual Prefilled Syringes America

BUSINESS BENEFITS FOR 2015:• LISTEN to keynote addresses from the leaders in human

factors engineering with expert input on reachingcertain patient populations, considerations andcompliance in device design and how can we ensurethe drug product is administered safely and effectively

• LEARN about the critical issues surrounding safetyassessments of pre-filled syringes from extractablesand leachables to sterility and needle stick preventionrequirements – NEW FOR 2015

• ENHANCE your understanding of labelling and pricingconsiderations with the competitive market forbiosimilars set to storm with patent expiries due

• ASSESS the future of pre-filled syringes with case studyled presentations addressing the challenges facedwith parenteral packaging innovations and reviewingthe strategies needed to overcome the hurdles withimportance insights into autoinjectors and pens

• ADDRESS the use of lyophilisation in pre-filled syringes, isthis the future vision?

SMi presents its 2nd annual conference and exhibition on...

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 29th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

27 - 28

APRIL2015

Assessing the future of pre-filled syringes to improve innovation and device development

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Pre-Filled SyringesAmerica

www.pfsamericas.com BOOK BY 19TH DECEMBER AND SAVE $400 • BOOK BY 30TH JANUARY AND SAVE $200

BOOK BY 27TH FEBRUARY AND SAVE $100

Register online or call +448709090711 to speak to an account executive

Sponsored by

"Excellent, informative and good quality" Delegate 2014

Advanced Delivery Systems to Enable Personalised Medicines

Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel andMr. Sall, Principal Consultant, ParExel

8.30am – 12.30pm

Will Drug Delivery in Coming Days be an Integral Part of DDM?- Diagnose, Deliver and Monitor

Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team,Beroe Inc. and Saikrishna Garrepalli, Procurement Management Representative,

Beroe Inc.1.30pm – 5.30pm

CHAIRS FOR 2015: Ravi Harapanhalli, Vice President, ParExel

William Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc.

KEY SPEAKERS FOR 2015:• Natalia Mazaeva, Usability Leader, Sanofi • Stephen Barat, Executive Director, Forest Laboratories,

a subsidiary of Actavis • Ed Israelski, Director of Human Factors, AbbVie• Scott Brown, Device Development Lead, Merck• Li-Chun Tsou, Global Device Technical Director,

AstraZeneca Pharmaceuticals• Kiran Singh, Associate Director, Sandoz• Michel Mikhail, Former Chief Regulatory Officer,

Executive Vice President, Global Regulatory -Governmental Relations, Fresenius Kabi NV/SA

• Mark Tsai, Principal Engineer, Drug Delivery, JanssenPharmaceuticals

Plus many more...

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Page 2: SMi Group's 2nd annual Prefilled Syringes America

Pharmaceutical industry’s perspectives:• Drug stability (minimize drug-syringe interactions by

mitigating leachables and extractables, flakes (lamellae)or deposits, glass fragments, and lubricant particles)

• Syringe durability• Cost

Manufacturer’s perspectives:• Simplified manufacturing/assembly processes to mitigate

batch variances• Consider stringent sterilization and packaging processes• Compliance of the mandatory "safety" PFS

Healthcare industry’s perspectives:• Avoid needlestick injuries• User-friendly• Eco-friendly (minimum residual of medicine,

recyclable device material)

Patient's perspectives:• User-friendly (convenience and safety in preparation

and self-administration)• Eco-friendly (minimum residual of medicine,

recyclable device material)• Price-friendly

Pre-Filled Syringes America Day One | Monday 27th April 2015

8.30 Registration & Coffee

9.00 Chair’s Opening RemarksWilliam Beierschmitt, Research Fellow, Drug Safety Research andDevelopment, Pfizer Inc.

HUMAN FACTOR STUDIES

OPENING ADDRESS9.10 The importance of the patient and how each individual differs

• Reviewing the patient populations and the needs of certainindividuals in device design

• How can we enhance products to ensure they’re specifically designed for the patient’s needs?

• Evaluating the best outcome for the patients, what factors should be considered

Ed Israelski, Director of Human Factors, AbbVie

9.50 Success Criteria – How can the FDA’s requirements be met? • Demonstrating safety and effectiveness in the hands of the user• Reviewing the design requirements for validation purposes• Are the customer requirements being met in design transfer? • Post –market surveillance – What observations can

be made? Natalia Mazaeva, Sr. Usability Leader, Global Usability and Risk Management, Device Development, Sanofi

CASE STUDY 10.30 End user needs and perspectives for device assembly

End User Needs and Perspectives are critical for final devicedelivery. This presentation will address the injectable devicetrends and flexibility required for an assembly machine to adaptto new market challenges while incorporating the ‘HumanFactor’. This presentation will also focus on recent Regulatoryupdates (11608) for Combination ProductsThe lecture will show:• Injectable Device Trends • Human Factor - Increased focus on safety, usability and

handling studies • Flexible standardized platforms to handle customized

assembly of pens and auto-injectors• Gentle handling of the filled glass container during

assembly of the device using proven liquid fill finish handling technology

Dena Flamm, Product Manager, Robert Bosch GmbH

11.10 Morning Coffee

KEYNOTE ADDRESS11.40 Convenience and compliance: empower the user

through good design• Reducing concerns by the end user is critical, what steps can

be taken to increase patient satisfaction?• Precision and safety go hand in hand, let’s address

considerations to ensure the product designed is safe andeffective

• How do we ensure the patient receives the exact dose intended?

Ben Bartfeld, Human Factors and Industrial Design Consultant, Otsuka Pharmaceutical Companies

12.20 What makes a pre-filled syringes ergonomic?• Addressing the importance of human factor studies

in device development• Assessing the possibilities to ensure the drug product

is administered safely and effectively • Working with clients concentrating on the design

based strategies Saikrishna Garrepalli, Procurement Management Representative, Beroe Inc.

1.00 BREAKOUT SESSION & OPPORTUNTY TO NETWORK PRE-LUNCH• Are we seeing a growing trend in drug delivery being

administered outside traditional medical settings? • How can we ensure this is safe?Host: William Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc.

1.30 Networking Lunch

CRITICAL ISSUES: SAFETY ASSESSMENT

2.40 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products • Background on leachables and pre-filled syringes• Why safety assessment for leachables is necessary• How to approach and conduct a leachable safety

evaluation• Current best practice recommendations and

examplesStephen Barat, Executive Director, Forest Laboratories, a subsidiary of Actavis

3.20 The Risk Assessment of Extractables - A Toxicological Window ofOpportunity• Ensuring compatibility of the profile of the pre-filled syringe with

the biologic• Avoiding changes in product quality• Material selection and final assessment of leachablesWilliam Beierschmitt, Research Fellow, Drug Safety Research and Development, Pfizer Inc.

4.00 Afternoon Tea

4.30 CASE STUDYIdentifying incompatibility causes and challenges • Assessing drug delivery studies and reflecting on the

impact of incompatibility

• Assessing the specific fit of LAV valves and specific issues surrounding prefilled syringe design

Kiran Singh, Associate Director, Sandoz GmbH

5.10 Assessing the safety of needle devices • Looking at the global demand of safety needle

devices• What necessary steps should be taken to ensure

a successful safety pre-filled syringe• Creative design of safety pre-filled syringesPei-Yang Phillip Hsu, Chief Executive Officer, SaferMedTechnologies Co. Ltd.

5.50 ROUND TABLE DISCUSSION AND NETWORKING OPPORTUNITY• Discussing the safety challenges surrounding pre-filled

syringesHost: Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies Co. Ltd

6.30 Chair's Closing Remarks and Close of Day One

NEW FOR2015!

NEW FOR2015!

Register online at: www.pfsamericas.com • Alternatively fax yo

Page 3: SMi Group's 2nd annual Prefilled Syringes America

Pre-Filled Syringes AmericaDay Two | Tuesday 28th April 2015

8.30 Registration & Coffee

9.00 Chair’s Opening RemarksRavi S. Harapanhalli, Vice President, ParExel

ENHANCING DEVICE DEVELOPMENT

OPENING ADDRESS9.10 Getting to market: Regulatory perspective

• Defining a pre-filled syringe as a product or device and its impact on regulatory approval

• Insight into the FDA’s current thoughtsRavi S. Harapanhalli, Vice President, ParExel,former FDA Senior Executive

9.50 Biosimilars and Delivery Devices…here we go! • Patent expiries for biologics are creating a new

competitive market for biosimilars in particular Monoclonal antibodies

• How to differentiate from the innovator with a device • Factors to Review: e.g. Interchangeability studiesMichel Mikhail, Former Chief Regulatory Officer, Executive Vice President, Global Regulatory- Governmental Relations, Fresenius Kabi NV/SA

10.30 Morning Coffee

CASE STUDY 11.00 The partnership reviewed between a pharmaceutical company

and the manufacturer/supplier• Overview of the relationship and how it was managed•An explanation on why the products have been developed

Shun Ogawa, Research Manager, Mitsubishi Gas Chemical Company, Inc.

11.40 Combination Product Considerations- Starting with the End in Mind• Evolving trends for the pre-filled syringe and self-injection markets• Industry/Supplier partnership is key to successful development

outcomes• Patient considerations and building strong product brands

through innovationRoyce Brockett, Senior Product Manager, West PharmaceuticalServices, Inc.

ROUND TABLE DISCUSSION12.20 The partnership reviewed between a pharmaceutical

company and the manufacturer/supplier• Choosing a partner: What are the decision criteria?• Who owns what: Equipment, IP, regulatory

requirements?• Managing the partnershipScott Brown, Executive Director/ Device Development Lead, Merck Research Laboratories

1.00 Networking Lunch

KEYNOTE ADDRESS2.00 Parenteral Device Strategy for Patient-Centric

Therapeutics• Advantages and Constraints of Pre-filled Syringes in Designing

Cutting Edge Devices• Global Design Control Process in Meeting Country

Specific Regulatory Expectations• Concurrent Engineering Commercialization Model

in Achieving Successful New Product Launch Li-Chun Tsou, Global Device Technical Director, AstraZeneca Pharmaceuticals

2.40 Product Line Management, sustaining activities• Engineering change plan• Product enhancement, material change, CAPA• Post market risk management• Design control, sustaining activitiesMark Tsai, Principal Engineer, Cell Therapy, Janssen R&D

3.20 BREAKOUT SESSION & OPPORTUNTY TO NETWORK• Glass v Plastic • The advantages and disadvantages• Is once still more favourable, if so why? Discuss Host: Ravi Harapanhalli, Vice President, ParExel

4.00 Afternoon Tea

CASE STUDY 4.30 Process Development studies to optimize process

parameters and finalize presentation formatCase studies included:• Development study to evaluate hold times on the

filing line • Stopper movement studies to evaluate effect of

headspaceAarti Gidh, Senior Scientific Investigator, GlaxoSmithKline

5.10 Electronics and Mobile Apps role in drug delivery and dosage adherence• How electronics and mobile apps in device development are

going to affect dosage areas in the medical device space • Some of major development in patch front which has circuitry

embedment and other innovative add on• Increasing penetration of electronics in drug delivery• Vision of leading device manufacturers and their take on

electronics future• Role of mobile apps in complimenting the growth of

electronics in device arenaChanderkanth Gautam, Domain Lead and Medical Device Community Leader, Beroe Inc.

5.50 Chairman’s Closing Remarks and Close of Day Two

Official PlatinumMedia Partner

NEW FOR2015!

NEW FOR2015!

NEW FOR2015!

Supported by

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

PHARMA• What worked

(Existing Actions)Pharma companiessometimes use mono-layer plastic containersto prevent the belowproblems, but all ofthem don’t haveenough oxygen barrier.

• What could’ve beenimproved? (Existing Problems forGlass Container - Breakage- Heavy Weight- Difficulty of disposal - Protein Adsorption- Inorganic Extractable,

etc.• Moving forward, what

would you have donedifferently? (Future actions)Some antioxidizingagent might be used forinjectable drugs.

SUPPLIER• What worked

(Existing solutions bysuppliers) Some supplies providemono-layer plasticcontainers instead ofglass, but all of themdon’t have enoughoxygen barrier.

• What could’ve beenimproved?- Oxygen Barrier

• Moving forward, whatwould you have donedifferently? (Our solutions)- We developed an

oxygen absorbingpolymer.

- We also developed 3layers-containers- The oxygen absorbing

polymer is used for the middle layer

- COP which is well-known as a high moisture

Page 4: SMi Group's 2nd annual Prefilled Syringes America

HALF-DAY POST CONFERENCE WORKSHOP AMWednesday 29th April 2015 | 8.30am – 12.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Advanced Delivery Systems to Enable Personalised Medicines

Workshop Leaders: Ravi S. Harapanhalli, Vice President, ParExel andMr. Sall, Principal Consultant, ParExel

Workshop overview:Run by one of the US’s leading figures in regulatory approval processesand drug delivery systems, Dr. Ravi Harapanhalli. This industry leadingworkshop will help you plan for smooth regulatory approvals and help withavoiding pitfalls that can cause expensive delays in taking your product tomarket.

Who should attend this workshop: R&D Scientists, Regulatory Affairs, Device specialists, Formulators,Business Development Staff

HALF-DAY POST CONFERENCE WORKSHOP PMWednesday 29th April 2015 | 1.30pm – 5.30pm | Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Will Drug Delivery in Coming Days be an Integral Part of DDM?- Diagnose, Deliver and Monitor

Workshop Leaders: Chanderkanth Gautham, Domain Lead of Medical Device Team, Beroe Inc. andSaikrishna Garrepalli, Procurement Management Representative, Beroe Inc.

Overview of workshop: Drug delivery device market would no longer exist as standalone entity. Ashealthcare longs to address all the solution through single gateway,technologies such electronic bandage, artificial pancreas pave their wayinto the market. They provide a holistic solution by diagnostic, delivering andmonitoring. This is likely to be future of healthcare.

Why you should attend this workshop:• To understand the platform that will be face of healthcare in coming days.• To understand how fast are new technologies are advancing in the space of

Medtech, and how considerable these devices were in addressing the gap thecurrently prevails will be the focus of the workshop.

About the workshop hosts:Chanderkanth Gautham A Medical Device ProcurementManagement Representative (Sr. Research Analyst) withexperiences in R&D, Human Factors, Contract Research Servicesfacilitating Medical Devices, Pharmaceutical, Cosmetics andHerbal Companies with Product development, Regulatory andPost Marketing (Medical Affairs) and Business Development

support activities across global regions.

Saikrishna Garrepalli Procurement Management Representative(Sr. Research Analyst) of leading medical device companies, Saihas experience in R&D, Human Factors, Contract ResearchServices and regulatory pathways. Currently he is analyst atMedical device team at Beroe handles various client initiativessuch as supplier relationship, negotiations and others.

About Beroe Inc. Beroe is procurement pioneer which addresses USD 15 Billion+ spend of itsclients globally. It carefully monitors the market for any sort of trend atsupplier or buyers end. And is very instrumental in benchmarking marketsand supplier capabilities across various facets of value chain ranging fromdesign to manufacturing. beroeinc.com

Programme8.30 Registration & Coffee

9.00 Introductions and Opening Remarks

9.45 Session 1: Quality-by-Design in the development of drug delivery systems

10.30 Session 2: Regulatory pitfalls to avoid

11.00 Coffee break

11.30 Session 3: New combination product regulations and how to comply with them

12.00 Session 4: How to accelerate approval through FDA

12.30 End of Workshop

Why you should attend this workshop:• Accelerate the time it takes to

take your drug delivery system tomarket

• Find out how to navigate newcombination product guidelines

• Assess the right time to start thinkingabout your drug deliverymechanism

• Develop a strategy for product lifecycle management by switchingover to PFS

• Understand how to apply the FDAQuality SystemRegulation todelivery device development

• Know how to apply FDA DesignControls to delivery devicedevelopment

• Get to appreciate how to selectionof a delivery device developmentpartner

• Perform risk analysis and HumanFactors assessment

About the workshop host: Dr. Ravi Harapanhalli advises bio/pharmaceutical companies onCMC regulatory strategies and Quality-by-Design approaches tomedicinal product development and flexible regulatoryapproaches.

About the workshop co-leader:Mr. Sall is a Principal Consultant with PAREXEL Consulting inWaltham, MA. PAREXEL provides clinical trial, clinical datamanagement, medical and regulatory services to thepharmaceutical and medical device industries.

About ParExel:Over the past 30 years, ParExel has developed significant expertise toassist clients in the worldwide pharmaceutical, biotechnology andmedical device industries with the development and launch of theirproducts in order to bring safe and effective treatments to the globalmarketplace for the patients who need them. Headquartered nearBoston, Massachusetts, ParExel operates over 77 locations throughoutmore than 51 countries around the world, and has over 14,400employees. www.parexel.com

Programme1.30 Registration and Coffee

2.00 Will drug delivery in coming days be integral part of DDM <diagnose, deliver and monitor>

Areas Covered• Introduction on these developments• Some case studies indicating the inception of the trend• Will developments in non-invasive sensor based

technologies and automatic modes of delivery increaseinclination of patients and physicians to home caretechnologies.

• Do acquisition of monitoring device companies byMedtech giants’ indicate bigger role of DDM platformsin future?

3.30 Coffee Break

4.00 Will artificial pancreas penetration in market pave way fornon-conventional diabetic therapy?Areas to be covered• Will the aforementioned platform challenge the

conventional, glucose measurement and injectiontherapy to a significant amount?

• Does this mean that conventional modes insulin deliveryvia auto injectors, pen injectors now needs a massivescale up technology wise?

• Who are those technology pioneers that need specialmention on their recent developments in same space?

5.30 End of Workshop

Page 5: SMi Group's 2nd annual Prefilled Syringes America

SPONSORED BY:

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquelytailored to complement your company’s marketing strategy. Prime networking

opportunities exist to entertain, enhance and expand your client base within thecontext of an independent discussion specific to your industry.

Should you wish to join the increasing number of companies benefiting fromsponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or

email: [email protected]

Pre-Filled Syringes Americas

Bosch Packaging Technology is the world leader in the design and manufacture of pharmaceuticalprocessing and packaging systems. Bosch offers a range of syringe filling systems in both nested andbulk styles of systems. Bosch also now offers syringe pen assembly systems and single use dosingsystems with scalable solutions. With Bosch one supplier solutions are a real possibility.www.boschpackaging.com

JOT Automation is driven by a passion to develop and manufacture test and production solutions formobile devices, components and electronics. JOT Automation offers product platforms to solveversatile volume manufacturing challenges in the most cost-effective manner. The company is aglobal partner for several industry leading companies in the telecom, automotive and life scienceindustries. www.jotautomation.com

Mitsubishi Gas Chemical (MGC) is well-known as an expert in unique polymers and oxygen absorbers.Based on our experience and expertise, MGC has successfully developed multilayer plastic vial andsyringe with oxygen absorbing function. MGC believes they will be an only solution to replace glasswith plastic. www.mgc.co.jp/eng

West works side by side with its healthcare partners from concept to the patient, designing andmanufacturing packaging, diagnostic and delivery systems that promote the efficiency, reliabilityand safety of their products. Every day, West is leading the way with cutting-edge technologies andquality systems, a thorough understanding of global regulatory compliance, and an unmatched andgrowing knowledge base of relevant pharmaceutical product testing, development and packaging. Based in Exton, Pa., West supports its customers from sales, manufacturing, customer support andresearch and development locations in North and South America, Europe, Asia and Australia.www.westpharma.com

Want to know how you can get involved?

Interested in promoting yourservices to this market?

Contact Julia Rotar, SMi Marketingon +44 (0) 207 827 6088, or email:

[email protected]

WHO SHOULD ATTEND:

Those involved in the following:

• Pharma Development• Engineering• Manufacturing

Technology• Biopharma Operations• Regulatory Affairs• Parenterals

• Packaging• Formulation Aseptic• Device Development• Device Design• Labelling• Manufacturing• Drug Delivery

• Formulation & AsepticFilling Technologies

• Chemistry Manufacture Controls (CMC)

• Quality Assurance• Safe Medication

Practice

11

2 BREAKOUT SESSIONS

4 CASE STUDIESLEADING PHARMACOMPANIES SPEAKING

2 KEYNOTE ADDRESSES

100+ ATTENDEES

2 ROUND TABLE DISCUSSIONS

Attendee by Location

USA 71%

Europe 17%

India 5%

Canada 7%

KEY HIGHLIGHTS:

Page 6: SMi Group's 2nd annual Prefilled Syringes America

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

POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

PRE-FILLED SYRINGES AMERICA Conference: Monday 27th & Tuesday 28th April 2015, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA Workshops: Wednesday 29th April 2015, USA

4 WAYS TO REGISTERwww.pfsamericas.com

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email [email protected]

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 creditcard details will be requested and payment taken before entry to the event. Bookings within 7 daysof event 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, providingthat cancellation is made in writing and received at least 28 days prior to the start of the event.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 unableto attend 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 parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager [email protected] or visitour website www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.

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□ Conference & 2 Workshops $2997.00□ Conference & 1 Workshop AM □ PM □ $2398.00□ Conference only $1799.00□ 2 Workshops only $1198.00□ 1 Workshop only AM □ PM □ $599.00First 25 Pharmaceutical Companies to register□ Conference & 2 Workshops $2597.00□ Conference & 1 Workshop AM □ PM □ $1998.00□ Conference only $1399.00□ 2 Workshops only $1198.00□ 1 Workshop only AM □ PM □ $599.00

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□ Book by 19th December 2014 to receive $400 off the conference price □ Book by 30th January 2015 to receive $200 off the conference price□ Book by 27th February 2015 to receive $100 off the conference price


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