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www.smi-online.co.uk/2011europricing.asp Register online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

Andrea RappagliosiVice President, European GovernmentAffairs & Head of Brussels OfficeGlaxoSmithKline

Peter Kolominsky-RabasDirector, Interdisciplinary CentreHealth Technology Assessment andPublic Health

Martina GarauSenior EconomistOffice of Health Economics

Isabel HenkelDirector Access & ReimbursementJohnson & Johnson Medical

Markus JahnManager PricingNovartis Pharma

Henderson AzevedoMarket Pricing Director Northern &Central Europe and CanadaNovartis Pharma

Jan PosthumusHead of Market Access & Market ResearchBasilea Pharmaceutica International Ltd.

Frank Thoss, LawyerStrategic Policy AffairsVFA

Elke HunscheDirector, Head of Health Economics &PricingActelion Pharmaceuticals

KEYNOTE SPEAKERS:

SMi present their 17th Annual Conference on...

European Pharmaceutical Pricing and Reimbursement

Monday 31st October & Tuesday 1st November 2011Radisson Blu Hotel Basel, Switzerland

2011 has brought huge changes to thehealthcare landscape – the global economiccrisis and rising healthcare costs have causedgovernments to take cautious approachestowards pricing and reimbursement. With anessential review of the key challenges anddevelopments in VBP, AMNOG and other EUpolicy challenges, SMi's 17th annual EuropeanPharmaceutical Pricing and ReimbursementConference will feature presentations on thelatest P&R issues from the industry’s mostsenior professionals and academics.

CONFERENCE HIGHLIGHTS

• Get to grips with the facts and consequences of Germanys AMNOG• Debate EU policy challenges in access to medicines in Europe• Analyse market access in new emerging markets• Understand Value Based Pricing: Principles and practice in the UK

policy context• Get up to speed with the latest regulations within P&R• Discover the value of collaboration in HTA and managed entry

schemes

Sponsored by

PLUS TWO INTERACTIVE POST-CONFERENCE WORKSHOPSWednesday 2nd November 2011, Radisson Blu Hotel Basel, Basel, Switzerland

Workshop A - Market Access in Emerging Markets: Overview of growthopportunities and key market access challenges in emerging markets

Hosted by Gustav Ando, Director, Healthcare & Pharma, IHS Global Insight, Aparna Krishnan, Manager, Emerging Markets,Healthcare & Pharma, IHS Global Insight, Ruben Gennero, Research Analyst, Healthcare & Pharma, IHS Global Insight

8.30am - 12.30pm

Workshop B - Cooperation with Payors as a Means for AttainingReimbursementHosted by Norbert Jersch, Partner, Roman Rittweger Advisors in Healthcare

1.00pm - 5.00pm

OTHER SPEAKERS INCLUDE:

Register online at www.smi-online.co.uk/2011europricing.asp • Alternat

Supported by

European Pharmaceutical Pricing and ReimbursementDay One | Monday 31st October 2011 www.smi-online.co.uk

June 201127/28 RNAi, miRNA, siRNA29/30 Pharmaceutical Portfolio & Product

Life Cycle Management29/30 Pharmaceutical Nanotechnology29/30 KOL Management and MSL

Best Practice in Europe (Munich, Germany)

July 201106/07 ADMET06/07 Social Media in the Pharmaceutical Industry11/12 BioBanking

18/19 Pharmaceutical and Clinical Trial Logistics AsiaPacific (Singapore)

20/21 Pre Filled Syringes Asia (Singapore)

September 201119/20 Biomarkers in Clinical Trials26/27 Biosimilars and Biobetters28/29 KOL Liaison and MSL Best Practice

October 201103/04 Managing Partnerships with CROs10/11 Pharmaceutical m-Health12/13 GP Commissioning

19/20 COPD: Novel Therapeutics and ManagementStrategies

24/25 Point of Care Diagnostics - Market Opportunities andTechnology Trends

November 201131 Oct/1 Nov European Pharmaceutical Pricing

& Reimbursement (Switzerland)16/17 Clinical Trials in CNS21/22 Cell Based Assay

December 20115/6 Cold Chain Distribution

PHARMACEUTICAL FORWARD PLANNER

All conferences take place in central London, UK – unless indicated otherwise in brackets

8.30 Registration & coffee

9.00 Chairman's opening remarksDonald Macarthur, Global Pharmaceutical Business Analyst

EU POLICY CHALLENGES

KEYNOTE ADDRESS9.10 EU policy challenges in access to medicines in Europe: the value of

collaboration in HTA and managed entry schemes• Assessment and Appraisal: is there a scope for European

collaboration in HTA to prove clinical value to governments andpayers?

• How the new challenges of “valuable innovation” can be addressedin order to meet priorities in healthcare?

• Will Managed Entry Schemes provide a refined tool to addressuncertainties in patients access?

• Can stakeholders contribute effectively to the setting of sharedrules?

Andrea Rappagliosi, Vice President, European Government Affairs &Head of Brussels Office, GlaxoSmithKline

KEYNOTE ADDRESS9.50 The role of HTA agencies

• HTA expectations in late phase development• HTA agency policy and practice globally: comparing and contrasting

different models• Opportunities for Early Engagement with HTA agenciesPeter Kolominsky-Rabas, Director, Interdisciplinary Centre, HealthTechnology Assessment and Public Health

10.30 Morning Coffee

AMNOG

11.00 Pricing in Germany with new AMNOG • Benefit assessment of launch drugs and in-market brands • Pricing roadmap after benefit assessment - fixed price or central

price-negotiation • First experiences with the new regulation and outlookMarkus Jahn, Manager Pricing, Novartis Pharma

11.40 Germanys AMNOG: Facts and consequences• Regulation of the German pharmaceutical market before AMNOG

before Jan 1st 2011• AMNOG-process of early benefit assessment and central price-

negotiations in detail• Possible consequences for other countriesFrank Thoss, Lawyer, Strategic Policy Affairs, VFA - GermanAssociation of Research-Based Pharmaceutical Companies

12.20 Networking Lunch

ORPHAN DRUGS

1.50 Orphan Drug P&R in Europe: Are the payers biting back?

• Situation with approved orphan drugs in EU-5

• Vital role of funding

• What payers won't buy

• How and where HTA limits access

• Successful company strategies

Donald Macarthur, Global Pharmaceutical Business Analyst

2.30 Orphan Drug Challenges in Europe and Future Opportunities for

Development

• Critical success factors and challenges

• Future opportunities in orphan drug development

Elke Hunsche, Director, Head of Health Economics & Pricing,

Actelion Pharmaceuticals

3.10 Afternoon Tea

3.40 Market Access to Orphan Drugs in Italy

• Mechanisms for “early reimbursement” of orphan drugs

• The pricing and reimbursement process for orphan drugs

• Orphan drugs and innovation

Laura Crippa, Director, Market Access and Pricing, Temas S.r.l.

Unipersonale

4.20 Change Drivers in pricing and reimbursement practice

• Changing macroeconomic environment – countries under economic

pressure

• Envolving stakeholder roles – the patient

• P&R evaluation price setting and reimbursement mechanisms

• Increased use of generics and similar - perceptions

Jorge Wernli, Vice President, Global Pricing and Government Affairs,

Vifor Pharma

5.00 Chairman’s Closing Remarks and Close of Day One

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

European Pharmaceutical Pricing and ReimbursementDay Two | Tuesday 1st November 2011 k/2011europricing.asp

Want to know how you can get involved? Interested in promoting your pharmaceutical services to this market?

Contact Kiran Sharma, SMi Marketing on +44 (0)20 7827 6050, oremail: ksharma@smi-online.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages,uniquely tailored to complement your company’s marketing strategy.Prime networking opportunities exist to entertain, enhance and expandyour client base within the context of an independent discussion specificto your industry. Should you wish to join the increasing number ofcompanies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

8.30 Re- Registration & coffee

9.00 Chairman's opening remarksNeil Palmer, President and Principal Consultant, PDCI MarketAccess Inc

ESTABLISHED MARKET OVERVIEW

KEYNOTE ADDRESS9.10 Value based pricing - Principles and practice in the UK policy

context• Approaches to value base pricing (VBP) • Lessons learnt from international experience of VBP • Introducing VBP in the UK:

- The Department of Health consultation - How might VBP be implemented and what are the expectedconsequences?

Martina Garau, Senior Economist, Office of Health Economics

KEYNOTE ADDRESS9.50 Market access in European Established Markets

• Overview of key stakeholders in Europe’s established markets• Who are the key agencies in the market• Understanding HTA regulations in EuropeIsabel Henkel, MPH, Director Access & Reimbursement, Johnson &Johnson Medical

10.30 Morning Coffee

MARKET ACCESS

11.00 Market access in emerging markets• Recent developments and future trends• Opportunities and threats - a pharmaceutical industry perspective • Lessons from developed marketsHenderson Azevedo, Market Pricing Director Northern & CentralEurope and Canada, Novartis Pharma

11.40 Canadian Market Access Update• Overview of Canadian health care system and pharmaceutical

funding • Price regulation and the new Patented Medicine Prices Review

Board (PMPRB) guidelines• CADTH - Common Drug Review (CDR), pCODR (oncology drugs),

INESSS (Quebec), provincial and private reimbursement schemes • Implications of the Ontario 25% pricing rule for generics and the

evolution of Product Listing Agreements (PLAs)• Outlook for Canadian pricing & reimbursement W. Neil Palmer, President & Principal Consultant, PDCI MarketAccess Inc.

12.20 Networking Lunch

1.50 The patient’s role in market access in public healthcare systems

• Increasing patient choices in an equitable way

• Patient-reported outcome measures

• Achieving maximum levels of patient and market access

Bertram Haussler, Chairman of the Board of Management, IGES

Insitut. Berlin

2.30 The access marketing mix for launch products

• Access marketing for the different stakeholders

• Preparation for launch from an access perspective: timelines,

tools and techniques

Jan Posthumus, Head of Market Access & Market Research, Basilea

Pharmaceutica International Ltd

3.10 Afternoon Tea

3.40 Latest regulations within pricing and reimbursement

• EU initiatives in pricing and reimbursement

• Risk Sharing Agreements

• Patient Access Schemes

James Killick, Partner, White & Case LLP

4.20 Sweden Market Access update

• Cost-effectiveness and cost utility

• What is the value at stake?

• Price analysis for new product candidates

Jacob Brun, Pricing & Reimbursement Director, AstraZeneca

5.00 Chairman’s Closing Remarks and Close of Conference

PDCI Market Access (PDCI) is Canada’s leadingpharmaceutical pricing and reimbursementconsultancy. Established in 1996, the firm assistsclients navigate the complex pricing and market

access challenges facing pharmaceutical manufacturers. In particular, PDCI helps pharmaceuticalcompanies develop successful pricing and reimbursement strategies and prepare comprehensivesubmissions to CADTH/CDR, INESSS, public & private payers and the Patented Medicine PricesReview Board (PMPRB). The Canadian market access capabilities are supported by PDCI’scomprehensive public payer claims database and the industry standard Canadian Drug Benefits Plan(CDBP) reference guide. PDCI also maintains extensive databases of international pharmaceuticalprices in support of PDCI’s international payer research and global pricing strategy engagements.Headquartered in Ottawa, PDCI features a senior team of bilingual market access professionals withextensive pricing and reimbursement experience. www.pdci.ca

Sponsored by

Workshop A Market Access in Emerging Markets

Overview of growth opportunitiesand key market access challenges in

emerging markets.

In association with

Overview of WorkshopIHS Global Insight Country Intelligence provides constantlyupdated analysis of the business conditions, economicprospects and risks in over 200 countries.

Find out about the growth opportunities in emerging marketsincluding BRIC-MT countries, Philippines, Indonesia, Kenyaand South Africa. Understand the evolution of healthcarepolicies and their impact on pricing and reimbursement.Identify the unique challenges to market access in thesecountries in the context of global pricing and reimbursementtrends.

• Monitor and understand developments as economic andpolitical conditions change

• Assess growth and development potential for individualeconomies and regional markets

• Analyze relative risks among countries around the world

Agenda8.30 Registration and coffee

9.00 Welcome and Introduction

9.10 Emerging Versus Advanced Markets• Forecasted Outlook in Emerging Versus Advanced

Markets• Growth Opportunities in Emerging Versus

Advanced Markets• The Unique Challenges of Emerging Markets

9.50 BRIC-MT Markets Overview• Best Growth Opportunities in the BRIC-MT Region

10.30 Coffee Break

11.00 Latin America Overview• P&R Regulations Evolution in Latin America

11.40 The Next Frontier: Second Tier Emerging Markets• Growth opportunities and challenges in

Philippines, Indonesia, Kenya, South Africa

12.30 Close of workshop

About the Workshop Leaders:Ruben Gennero is the healthcare analyst for LatinAmerican markets and Spain. Before joining IHSGlobal Insight, Ruben worked at the ChileanMinistry of Health as a Health Management andwas Policy Advisor for the Chilean health

authorities, participating in healthcare and pharmaceuticalreforms assessments and carrying out different proposals asproject manager. He left the Ministry of Health and worked asan external advisor of GlaxoSmithkline Chile, focusing onhealth policy and market access issues.

Aparna Krishnan is Manager/Senior ResearchAnalyst at IHS Global Insight’s Healthcare &Pharma Practice in London in charge of thepractice’s subscription services namely WorldMarkets Healthcare and Pricing &

Reimbursement. Her areas of expertise includes corporatestrategies, health economics, market access, drug pricingand reimbursement and generics in the pharmaceutical andhealthcare space.

Gustav Ando leads the Healthcare and PharmaPractice at IHS. Formerly a healthcare analyst, hehas extensive experience in the fields of marketaccess, therapeutic development, drug safety,emerging markets and health outcomes. He has

developed numerous information tools for pharmaceuticalcompanies and has led consulting projects on global pricingtrends, reference pricing, risk-sharing agreements,therapeutic-specific market access strategies, bespokedatabase creation and internal corporate P&R strategybenchmarking.

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 2nd November 2011

Radisson Blu Hotel Basel, Basel, Switzerland.8.30am - 12.30pm

ABOUT THE SMi PHARMACEUTICAL TEAMSMi have been involved in thepharmaceutical industry since 1993 andhave developed a series of informative and

niche events, covering the latest issues anddevelopments surrounding the industry. Eventsbring together senior industry professionals andserving companies who have a focus on being at theforefront of developments in this area. SMi aim togenerate informed and topical discussion through themedium of both conferences and executive briefings.Our pharmaceutical events are research-based andcontent driven with regular contact with majorindustry personnel and cover a wide range of industrysectors. For more information, please visit www.smi-online.co.uk/pharma

Workshop B Cooperation with Payors as a Means

for Attaining Reimbursement

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 2nd November 2011

Radisson Blu Hotel Basel, Basel, Switzerland.1.00pm - 5.00pm

In association withRoman Rittweger Advisors in Healthcare

Overview of WorkshopThe pricing and reimbursement landscape is increasinglydirected by cost-benefit analyses through governmentagencies closely linked to payors' and governments' costcontainment initiatives. In order to convince payors of apharmaceutical product's benefit, seeking cooperationbetween the pharmaceutical industry and payors is ofutmost importance. In this interactive workshop, we willwork out strategies for approaching the relevant playersof public health systems in order to provide them witharguments for supporting a product's reimbursement.“Traditional”cost-saving value added services such asdisease management, targeted patient training or cost-sharing schemes will be addressed as well as promisingnew opportunities from linking smartphone apps topatient management platforms and to generateoutcomes data from that, e.g. register studies.

This Workshop Will Cover:• How payors can be motivated to enter pharma

cooperations• Some current best practice examples and new ideas• Development and discussion of participants' own ideas

for value added services

Agenda1.00 Registration & Coffee

1.30 Welcome and introduction

1.40 Reimbursement decision-making in keyEuropean countries• The pivotal position of public payors• Challenges for the pharmaceutical industry• Potential new opportunities

2.10 Interactive work in two-person small teams,supported by the workshop leader• Concrete services adding value to products to

be chosen by workshop participants• Possible strategies for approaching public payors

3.50 Coffee Break

3.50 Presentation and discussion of ideas developedin the working teams

5.00 End of Workshop

For more information and updates visit the conferencewebsite at www.smi-online.co.uk/2011europricing.asp

About the Workshop Leader:Norbert Jersch PhD is partner of RomanRittweger Advisors in Healthcare. For severalyears, he gained business experience atRoche Diagnostics where he had developedthe diabetes home monitoring market. Hebecame VP of global product planning and

marketing for the diabetes care product line. NorbertJersch joint and managed two small IT companies whichdeveloped software for documentation and QM andprovided IT services to physicians. In 2002 he managed4sigma GmbH, an innovative service provider for payorsand a market leader in disease management. Afterhaving restructured the company and its daughtersNorbert Jersch entered into the consulting business. Withhis expertise from implementing diabetes care and notonly diabetes products he became a pioneer in diabetesdisease management. He successfully set up excellentrelations with medical and governmental organizationsincluding IDF and WHO. He was the organizer of the firstWorld Diabetes Day in 1991. For the last few years he hasbeen working on value added service programs and oneHealth and IT solutions for Pharma and Medtechcompanies.

EUROPEAN PHARMACEUTICAL PRICING AND REIMBURSEMENTConference: Monday 31st October & Tuesday 1st November 2011, Radisson Blu Hotel Basel, Switzerland Workshop: Wednesday 2nd November 2011, Switzerland

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VENUE Radisson Blu Hotel Basel, Switzerland

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CONFERENCE PRICESI would like to attend: (Please tick as appropriate) Fee□ Conference & Interactive Workshops (A & B) £2597.00□ Conference & One Interactive Workshop £1998.00Please indicate which workshop you wish to attend: Workshop A □ Workshop B □□ Conference only £1399.00 □ Two Half-Day Workshops (A & B) £1198.00□ One Interactive Workshop £599.00 Please indicate which workshop you wish to attend: Workshop A □ Workshop B □PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional

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