@SMIPHARM

www.parallel-trade.com BOOK BY 31ST OCTOBER TO RECEIVE £300 OFF

BOOK BY 28TH NOVEMBER TO RECEIVE £100 OFFRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

CHAIR FOR 2015:

Eric Noehrenberg, Director, Regional Market Access Lead, Shire GmbH

KEY SPEAKERS INCLUDE: • Mike Isles, Executive Director, European Alliance for Access to Safe

Medicines• Prof. Bertram Häussler, Chairman of the Board of Management, IGES • Janice Haigh, Practice Leader, Market Access, Quintiles• John Jolley, Founder, Pharma Consult Europe Ltd• Antonio Mendonca Alves, CEO, MD Pharma SA• Dermot Glynn, Senior Adviser, Europe Economics• Leyla Hannbeck Chief Pharmacist, NPA• Chris Stothers, Partner, Arnold and Porter...plus many more

BUSINESS BENEFITS FOR 2015:• HEAR from true industry leaders in the field of Parallel Trade, and listen

to the latest from IGES on the influencing factors affecting the market• ENHANCE supply chain protection and patient safety with an

update on the Falsified Medicines Directive• BENEFIT from case study sessions on best practices and

implementation from a Chief Pharmacist and Wholesaler• JOIN ROUND TABLE DISCUSSIONS on the future of Parallel Trade will

generate debate, don’t miss out!

SMi Presents the 9th Annual Conference on… 9 - 10

FEB2015

Holiday Inn Regents Park Hotel, London, UK

Parallel TradeImprove patient safety by addressing theimplementation and best practices of parallel trade

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 11th February 2015, Holiday Inn Regents Park Hotel, London, UK

Parallel Trade – Management Strategies Workshop Leader: Janice Haigh, Practice Leader,

Market Access, Quintiles 8.30am – 12.30pm

Parallel Trade for Accession States Assessing the Problems

Workshop Leader: Martin Paltnoi, Senior Consultant, MPA Business Services Ltd

1.30pm – 5.30pm

“Informative and provocative conference. Well run, wellchaired and good networking opportunities” Delegate 2014

BOOK B

Y

31ST

OCTO

BER

AND SAVE £

300

BOOK B

Y

28TH

NOVEM

BER

AND SAVE £

100

Register online at: www.parallel-trade.com • Alternatively fax yo

9th Annual Parallel Trade Day One | Monday 9th February 2015

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Eric Noehrenberg, Director, Regional Market Access Lead, Shire

GmbH

PRICING, GENERICS & STAKEHOLDER ENGAGEMENT

OPENING ADDRESS

9.10 Overview of Parallel Trade and its Impact

•What is parallel trade?

•Who benefits from parallel trade? Where are negative impacts

of parallel trade?

•Key players in parallel trade and their respective strategies

•Meeting the challenges of parallel trade

Eric Noehrenberg, Director, Regional Market Access

Lead, Shire GmbH

9.50 Session Reserved for EAEPC

Speaker and presentation to be confirmed

10.30 Morning Coffee

11.00 Assessing pricing strategies for parallel trade

•Price strategy, price competition and equity – defending

differential pricing

•Understanding the role of price strategy in parallel trade

management

•What are the other options?

Janice Haigh, Practice Leader, Market Access,

Quintiles

KEYNOTE ADDRESS

11.40 Initiatives of Parallel Distributors in the context

of Falsified Medicines Directive

•Good Parallel Distribution Guidelines

•Early Warning Anti-CF Platform

•Joint Audits Initiative

•European Medicines Verification Organization

Tomasz Dzitko, Founder and CEO, Delfarma

12.20 Networking Lunch

1.30 Parallel Trade in Germany – Situation and perspective

•Parallel importation dynamics – assessing the impact

•The evaluation of new drugs in Germany – new paradigm

for Parallel Trade?

•Political and regulatory environment: What`s changed,

what is to be expected

Prof. Bertram Häussler, Chairman of the Board of

Management, IGES Institut GmbH

2.10 The Impact and Future of Parallel Trade

•UK Parallel Trade vs Eastern Europe

•The impact of Parallel Trade on the consumer

•Pharmacy registered Wholesalers vs Pharmaceutical

wholesalers

•Effects of market awareness between countries

Patrick O’Neill-Ortiz, Managing Director, Parallel

Pharma Ltd

2.50 Afternoon Tea

CASE STUDY SESSION – BEST PRACTICE AND IMPLEMENTATION

3.20 Case Study: The role of the pharmacists in parallel trade defined

•Distribution and supportive programme with the pharmacists

as the central person

•Channels and factors with regulations, market access and

other factors

•Sourcing parallel trade when they’re cheaper and how it’s

impacting the pharmacists

Leyla Hannbeck, Chief Pharmacist, NPA

4.00 The future of parallel imports within the EU

•The importance of free market economics

•Required regulatory framework

•Medical devices insight

Shan Hassam, Group Director, Veenak International Ltd.

4.40 Chairman's Closing Remarks and Close of Day One

Who should attend this conference: You should attend this event if you work in the ParallelTrade sector of the Pharmaceutical Industry withresponsibilities in Supply Chain, Market Access, GlobalPricing, Generics and Stakeholder Engagement.

Job titles include: • Head of Supply Chain • Head of Market Access

and Global Pricing• Head of Parallel Trade• Head of European Trade• Head of Distribution

• Practice Leaders• Pharmacists• Planning Managers• Lawyers• Attorneys

2013/14 Parallel Trade Attendees by Region:

UK 40%

Europe excluding UK 53%

USA 3%Middle East 4%

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

SMi offer sponsorship, exhibition, advertisingand branding packages, uniquely tailored tocomplement your company’s marketingstrategy. Prime networking opportunities existto entertain, enhance and expand yourclient base within the context of anindependent discussion specific to yourindustry.

Should you wish to join the increasing numberof companies benefiting from sponsoring ourconferences please call:

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

Supported by

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

9th Annual Parallel Trade Day Two | Tuesday 10th February 2015

8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Eric Noehrenberg, Director, Regional Market Access Lead,

Shire GmbH

THE IMPACT OF PARALLEL TRADE

KEYNOTE ADDRESS

9.10 EU perspective for Parallel Trade

•Assessing the impact of parallel trade on certain countries

•Concerns about medicines shortages to lower priced

countries

•Competition law – an overview of what’s likely

to happen over the next five years to impact

parallel trade

Suzanne Elvidge, Specialised Writer, Healthcare,

Pharmaceuticals and Business

9.50 Supply chain protection and patient safety

•Assessing the security of supply chain to

enhance patient safety

•Evaluating the complexity of European supply

chain

•Reviewing what the hurdles ahead may be

John Jolley, Founder, Pharma Consult Europe Ltd

10.30 Morning Coffee

11.10 Market Outlook and Macro Dynamics

•Developments in last decade

•Impact on patient and manufacturer

Dr Shabnam Hanassab, Senior Consultant,

IMS Health

11.40 Effects of parallel trade on affordable access to medicines

in the EU

•Effects on prices

•Effects on timing of launch

•Effects on reliability of supply

•Effects on innovation

Dermot Glynn, Senior Adviser, Europe Economics

12.20 Networking Lunch

FALSIFIED MEDICINES & PATIENT SAFETY

KEYNOTE ADDRESS

1.30 Intellectual Property Update

•Can brand names be changed in parallel trade? Recent

case law

•Specific Mechanism - the Advocate General’s Opinion?

•Other recent developments

•Practical implications

Christopher Stothers, Partner,

Arnold & Porter (UK) LLP

2.10 Patient Safety – Fighting the Fakes

•The evolving internet rogue pharmacy environment

•Law enforcement and collaborative voluntary actions

•Addressing the issue of online demand by patients

Mike Isles, Executive Director, European Alliance

for Access to Safe Medicines

2.50 Afternoon Tea

THE FUTURE OF PARALLEL TRADE

3.20 Government intervention in exporting countries, a new trend?

•Examples of government intervention is exporting countries

•Are governments trying to restrict exports?

Is this legitimate?

•Are there alternatives?

Antonio Mendonca Alves, CEO, MD Pharma SA

ROUND TABLE DISCUSSION

4.00 A clear divide still stands - The Big Debate!

•Ethics of Parallel Trade and the Originators

•Input and perspective on what the ethics of parallel trade

and the originators are

•Greece as a target – is ring fencing in place or will it be?

•Is parallel trade justified – different perspectives

Leaders:

Antonio Mendonca Alves, CEO, MD Pharma SA

Tomasz Dzitko, Founder and CEO, Delfarma

4.40 Chairman’s Closing Remarks and Close of Day Two

Want to know how you can get involved? Interested in promoting your services to this market?Contact Sarah Watson, SMi Marketing on +44 (0) 207 827 6134 or email: swatson@smi-online.co.uk

HALF-DAY POST-CONFERENCE AM WORKSHOPWednesday 11th February 2015

8.30am – 12.30pmHoliday Inn Regents Park Hotel, London, UK

A: Parallel Trade - Management Strategies

Workshop Host: Janice Haigh, Practice Leader, Market Access, Quintiles

Overview of the workshopFollowing feedback from SMi’s Parallel Trade Conferencesin 2013 and 2014 and a further masterclass in July 2013, this sell-out workshop will again run alongside our 2015conference. Parallel Trade continues to bring challengesto pharmaceutical manufacturers: challenges includinglogistics and supply, challenges of accuratemeasurement and of motivating affiliates in import andexport markets, challenges around revenue and profitand challenges of ensuring patient supply. This workshopis designed to help you address these challenges byproviding advice based on real experience. Theworkshop agenda will review the available strategicoptions including pricing and supply management andwill give clear recommendations. Ample time will beallowed for questions and discussion.

Programme

08.30 Registration and Coffee

09.00 Welcome and introductions

09.15 Background to parallel trade

09.30 PT management options

09.50 An overview of supply management

10.20 Coffee Break

10.50 Critical success factors

11.20 Review of tactical details

12.00 Discussion and Q&A

12.30 End of Workshop

About the workshop host:Janice Haigh, Practice Leader, Market Access, Europe• Joined Quintiles Consulting in January 2012 as

Practice Leader for Market Access in Europe• From 2006 to December 2011, Senior Director

Pricing and Market Access for Astellas Pharma Europe• Responsible for development and implementation of

pricing and market access strategy for new and in-marketproducts, working closely with brand teams and affiliates

• Responsible for all price management, analysing effectof price changes on other markets

• Designed, implemented and managed Astellas’s supplychain integrity program which ensured the matching ofsupply and demand of products in Europe

• Before joining Astellas in 2006, Janice worked inconsultancy for 20 years, including almost 10 years atIMS Health/Cambridge Pharma Consultancy

Responsible for leading projects involving pricing, paralleltrade, health economics and health policy. Clientsincluded European and global pharmaceuticalcompanies but also trade associations and governmentbodies such as the European Commission

About the Organisation: Quintiles (NYSE: Q) is the world’s largest provider ofbiopharmaceutical development and commercialoutsourcing services with a network of more than 29,000employees conducting business in approximately 100countries. We have helped develop or commercialize allof the top-50 best-selling drugs on the market. Quintilesapplies the breadth and depth of our service offeringsalong with extensive therapeutic, scientific and analyticsexpertise to help our customers navigate an increasinglycomplex healthcare environment as they seek toimprove efficiency and effectiveness in the delivery ofbetter healthcare outcomes. To learn more aboutQuintiles, please visit www.quintiles.com.

HALF-DAY PRE-CONFERENCE PM WORKSHOPWednesday 11th February 2015

1.30pm - 5.30pmHoliday Inn Regents Park Hotel, London, UK

B: Parallel Trade for Accession States Assessing the Problems

Workshop Host: Martin Paltnoi, Senior Consultant,MPA Business Services Ltd

Overview of workshop: This workshop will look to give an overview and insightinto the interpretation of the specific mechanismsfrom both an originator’s perspective and a paralleltrader’s perspective. The importance of ParallelTrade from the Accession States will be discussed inaddition to other matters likely to affect the paralleltrade from Accession States.

Programme:

1.30 Registration and Coffee

2.00 Introduction and Overview - Interpretation of the Specific Mechanism:a) From the originators perspectiveb) From the parallel traders view

2.30 How important is parallel trade from AccessionStates

3.00 What is the view of parallel trade from AccessionStates in the post-Specific Mechanism

3.30 Coffee Break

4.00 Review of the Specific Mechanism as itappears in the Accession Treaty and as a resultof subsequent court actionWhat are the differences in the differentAccession States likely to influence the SpecificMechanism and Parallel Trade from those states.

5.00 Discussion and Q&A- Other matters likely to effect the parallel tradefrom Accession States, i.e. the need toupgrade MAs filed prior to 2008 (Croatia)(Appendix to Annex V - Accession Treaty).

5.30 End of Workshop

About the workshop host: Martin Paltnoi is the Chief Executive of MPAwhich was created in 1973 after spendingmany years as a professional marketresearcher involved mainly, but not exclusively,in providing business intelligence for pharmaceuticaland healthcare industries on a national andinternational level.

A qualified statistician and economist, was first introducedto pharmaceuticals when invited to be included in the small team to set up to provide audits forpharmaceuticals by IMS in 1959/1960. After thatintroduction to the market, spent a number of years in amarket research capacity in leading manufacturingcompanies where the results of research into businessintelligence have been applied. Since 1973, he has beensupplying a business intelligence service for the industryand is probably best known for his and his company’swork in pharmaceutical patents. This has also includedproviding a patent intelligence service for the paralleltrade industry sector. As such he has become a notedexpert in related matters like the Specific Mechanism,covering trade from the Accession States.

About the Organisation: MPA’s has built a reputation as one of the leadingbusiness intelligence experts in the pharmaceuticalsector. MPA’s consultancy work is intended to seek outand provide business intelligence on any aspect relatedto pharmaceutical and healthcare matters (on both anational and international basis). From competitiveintelligence to legal and pharmaceutical information,sales and marketing to demographic and culturalenquiries, MPA addresses any questions that are posedrelating to marketing and corporate strategic planningin pharmaceuticals and healthcare. To learn moreabout MPA, please visit www.mpasearch.co.uk

PARALLEL TRADE Conference: Monday 9th & Tuesday 10th February 2015, Holiday Inn Regents Park Hotel, London, UK Workshop: Wednesday 11th February 2015, London

4 WAYS TO REGISTER

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

www.parallel-trade.com POST your booking form to: Events Team, SMi Group Ltd, 2nd FloorSouth, 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 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 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 databasemanager@smi-online.co.uk or visitour website www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.

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□ Book by 31st October 2014 to receive £300 off the conference price

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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

VATVAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on liveStreaming, on Demand, Document portal and literature distribution for all UK customers andfor those EU Customers not supplying a registration number for their own country here.______________________________________________________________________________________________

CONFERENCE PRICES

I would like to attend: (Please tick as appropriate) Fee Total□ Conference & 2 Workshops £2697.00 + VAT £3236.40□ Conference & 1 Workshop AM □ PM □ £2098.00 + VAT £2517.60□ Conference only £1499.00 + VAT £1798.80□ 1 Workshop only AM □ PM □ £599.00 + VAT £718.80□ 2 Workshops £1198.00 + VAT £1437.60

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 theDocument Portal. Presentations that are available for download will be subject todistribution rights by speakers. Please note that some presentations may not be availablefor download. Access information for the document portal will be sent to the e-mailaddress provided during registration. Details are sent within 24 hours post conference.