39614 Global Generics - SJ Berwin

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IIR’s 6 th Annual 

Global Generics 

Strategy Summit 

Learn how best to increase market share in the 

global generics industry 

6th-7th February 2007, Hotel NH Eurobuilding, Madrid, Spain 

2007 Keynote Speakers: 

Stephen Stead, 

Chief Executive Officer, 

Polpharma, Poland 

Dr. Brian Tempest, 

Chief Mentor & Executive Vice Chairman of the Board, 

Ranbaxy Laboratories Limited, India 

Dr Dilip Shah 

Chairman 

International Generic Pharmaceutical Alliance 

and Secretary General 

Indian Pharmaceutical Alliance, India 

Jonas Tryggvason, 

Executive Vice President, Central and Eastern Europe & 

Asia Sales, Actavis Group, Iceland 

Tim Oldham 

Vice President Business Planning and 

Operations Effectiveness 

Mayne Pharma, UK 

Industry experts confirmed to present include: 

• Bill Haddad, Chairman and Chief Executive Officer, Biogenerics, USA 

• Rory O’ Riordan, Chief Executive Officer, Clonmel Healthcare, and Chairman, Stada Inc., ROI 

• Dr. Klaus Maleck, Chief Financial Officer and Vice President Business Development, 

BioGeneriX AG, Germany 

• Dr. Michel Mikhail, Director, Head of Regulatory Affairs, Europe, CIS & Africa, Ranbaxy, UK 

• Dr. Angel Calvo, General Manager, Dr Reddy’s Laboratories LTD, Spain 

• Roberto Terruzzi, European General Manager, Almus Pharmaceuticals, UK 

• Zeynep Ulusoy, Deputy General Manager, Technical Divisions, Nobel Ilaç, Turkey 

• Gabriele Eibenstein, Head of Division, Drug Regulatory Affairs, Federal Institute for Drugs 

and Medical Devices, BfarM, Germany 

• Sharon Anglin Treat, Executive Director, National Legislative Association on Prescription 

Drug Prices, USA 

• Michael Brückner, Executive Partner, Accenture GmbH, Germany 

• Malcolm Ross, Generapharm-Training and Consultancy, Switzerland 

• Brian Lovatt, Vision Healthcare Consultancy Ltd, UK 

• Chris Thornham, Solicitor - Patent & Pharmaceuticals Group, SJ Berwin LLP, London, UK 

• Campbell Forsyth, Sole Practitioner, Forsyth Simpson, UK 

• Max Vetter, Senior Analyst, Counterfeiting Intelligence Bureau, International Chamber of 

Commerce, UK 

• Jim Furniss, Director, Pricing and Reimbursement, Bridgehead International Limited, UK 

Special rates available for new EU Member States and Accession countries, for more 

info please contact +44 (0)20 7017 7481 or email registrations@informa-ls.com 

2007 Summit key benefits: 

• Design your own agenda by choosing between 

distinct streams 

• Hear recent effective strategies from CEOs of the 

most successful generics companies 

• Gain insight into the biosimilars new business era 

• Learn from generics industry case studies and 

develop new effective business strategies 

• Assess the enormous impact of the Plavix case 

• Learn about the trends in pricing and reimbursement 

for generics in the EU and US 

WORKSHOPS AND SEMINARS 

www.iir-lifesciences.com/generics 

BOOKINGS HOTLINE 

+44 (0)20 7017 7481 

Don't miss 

vital keynote 

addresses from 

Polpharma and Ranbaxy * 

Pre-Conference Workshop 

Monday 5th February 2007 

How Can Generics Companies be Innovative? 'First-to- 

Market' Strategies and Effective Techniques for the 

Portfolio Management of Generic Drugs' 

Led by: Andrew Willis, European Regulatory Affairs Director, 

Cardinal Health, UK 

Pre-Conference Evening Seminar 

Monday 5th February 2007 

Merger & Acquisition Activity within the Generics Market 

Led by: Tommy Erdei, Executive Director of Healthcare Banking, 

UBS Warburg, UK 

Post-Conference Workshop 

Thursday 8th February 2007 

Legal Briefing for the Generics Industry 

Led by: Lorna Brazell, Partner, Bird & Bird, UK 

media partners 

"A well organised and managed high-level conference, 

which should be a must for everyone in industry!" 

Ros Kazakov, Exec Director, ABPhM 

Delegate, Global Generics Strategy Summit, 2006 

Conference Code: CQ2134

08:30 Coffee and registration 

09:00 Opening remarks from the Chairperson 

Dr Dilip Shah 

Chairman 




09:10 The key role and growth of generic medicines in enhancing healthcare 

provision: Providing access to safe effective medicines at lower costs 

• Generics market dynamics 

• How do generic medicines contribute annually to European healthcare 

systems? 

• Generic medicines vs. branded products: Increasing consumers’ choice 

• Overview of generic medicines role in Central and Eastern Europe 

• Future opportunities for generics companies in European healthcare 

markets 

Stephen Stead 

Chief Executive Officer 

Polpharma Group, Poland 

09:50 What ails the generics industry? 

• What is endangering the generics industry? 

• What to do about it? 

• Combating the increasing generics competition and retaining market share 

• Techniques to be prepared for innovators’ defensive strategies against the 

generics industry 

Dr Dilip Shah 

Chairman 




10:30 Coffee break 

6th Annual 

Global Generics Strategy Summit 


11:00 The challenges from India in the Global generics marketplace 

• India advantages 

• Pharma advantages 

• China vs. India 

• India’s downsides 

Dr Brian Tempest 

Chief Mentor & Executive Vice Chairman of the Board 

Ranbaxy Laboratories Limited, India 

15:10 Overview of pricing strategies and reimbursement applications for 

generics in the EU: Maximising profitability and speed to market 

• Reviewing the EU legal pricing actions against generics companies 

• What are the latest pricing controls? 

• Unbranded vs. branded generics pricing 

• What are the new arrangements for the reimbursement of ‘standard’ 

branded generic medicines? 

• How is the increasing competition in the generics market going to 

impact pricing decisions of EU authorities? 

Rory O’ Riordan 


Clonmel Healthcare 

And Chairman 

Stada Inc., ROI 

15:50 Pricing and Reimbursement in the UK 

• Overview of the drug approval process in the UK for generics 

• The increased use of generics in the UK: How does it impact pricing 

and reimbursement? 

• Analysing the opportunities presented by the Pharmaceutical Price 

Regulation Scheme 2005 (PPRS) 

• What are the criteria for generics reimbursement in the UK? 

Brian Lovatt 

Vision Healthcare Consultancy Ltd, UK 

Conference Day One: Tuesday 6th February 2007 

STREAM A 

TRENDS IN PRICING AND REIMBURSMENT FOR GENERICS 

KEYNOTE OPENING SESSIONS 

11:40 Opportunities in the Central Eastern-European and Asian generics 

markets 

For more information about the content of the presentation, please visit: 


Jonas Tryggvason 

Executive Vice President, Central and Eastern Europe & Asia Sales 

Actavis Group, Iceland 

12:20 Lunch 

13:30 Biosimilars: The start of a new era 

• The emergence of biosimilars: How far have we got? 

• Higher prices but higher costs of goods: Will biosimilars really increase 

profit? 

• Clarifying regulatory frameworks in the EU and US 

• Overcoming the complex and unclear nature of biotech patents 

Tim Oldham 

Vice President Business Planning and Operations Effectiveness 

Mayne Pharma, UK 

14:10 Building a generics company and gaining competitive advantage in a 

global market 

• Understanding global generics market dynamics: Where does your 

company fit? 

• Developing an effective ‘first to market’ strategy in the international 

generics market 

• Recommendations for strengthening your presence in the global generics 

market 

• Importance of developing a strong product pipeline to maintain market 

growth 

• The need for therapeutic diversity to maximise on opportunities 

Bill Haddad 

Chairman and Chief Executive Officer 

Biogenerics, USA 

14:50 Afternoon refreshments 

AFTERNOON STREAMED SESSIONS 

"Excellent programme and speakers; a very good analysis of 

the generics business" 

Ana Paula Pereira, Marketing and Sales Manager, Sidefarma, 

Portugal, Delegate, Global Generics Strategy Summit, 2005 

STREAM B 

THE DEVELOPMENT OF BIOSIMILARS: 

A NEW BUSINESS OPPORTUNITY 

15:10 Overview of the biosimilars market in Europe: 

Where do opportunities lie? 

• Identifying key industry players in biosimilars and their impact on the 

EU market for biotech products 

• Overview of the two major biologics sectors: 

- Recombinant protein therapeutics 

- Monoclonal antibodies 

• What are the recent market indicators? 

• Identifying and overcoming barriers to entry: 

- Reproducibility 

- Comparability testing 

- Clinical trials 

- Costs of R&D 

- Costs of goods 

• Identifying difficulties in reproducing biologics 

• What are the leading countries? 

• Identifying opportunities in emerging markets 

• The need for a strong and different marketing and launch strategy 

Dr Klaus Maleck 

Chief Financial Officer and Vice President Business Development 

BioGeneriX AG, Germany 

Book now: Tel: +44 (0)20 7017 7481 • Fax: +44 (0)20 7017 7823

16:30 The pricing and reimbursement landscape in the US 

• What is the impact of attempts to control costs of drugs in the US? 

• Assessing the impact of the growth of generics on the pricing and 

reimbursement system 

• Price controls and reimbursement issues in the US 

• Comparison with pricing and reimbursement processes in the European 

generics market 

• Future pricing and reimbursement issues in the US 

Sharon Anglin Treat 

Executive Director 

National Legislative Association on Prescription Drug Prices, USA 

17:10 Closing remarks from the Chairperson 

Dr Dilip Shah 

Chairman 




17:20 End of conference day one Join us at the end of day one for an informal drinks reception 

08:00 Coffee and registration 

6th Annual 



15:50 Overcoming pricing and reimbursement issues for biosimilars in 

Europe. 

• The pricing and reimbursement environment of biologics 

• Biosimilars - opportunities and challenges 

• The payers' perspective 

• Commercialising biosimilars 

• Pricing for biosimilar products 

• How good are the opportunities? 

Jim Furniss 

Director, Pricing and Reimbursement 

Bridgehead International Limited, UK 

16:30 Case study: Sandoz Omnitrope - The first biosimilar approved 

• Review of the business case for launching Omnitrope 

• Demonstrating product characteristics 

• Approval in the EU in April 2006 and the US in May 2006: Blazing the 

trail! 

• How were the validation criteria set? 

• What were the challenges and how did Sandoz manage to overcome 

them? 

Speaker to be confirmed, for more information please visit: www.iirlifesciences.com/generics 


Conference Day Two: Wednesday 7th February 2007 

STREAM C 

EXPLORING THE LATEST REGULATORY AND LEGAL ISSUES 


08:40 Launching generic products: Clearing the way of interim injunctions 

• Clearing the patent and regulatory hurdles 

• Interim injunctions and litigation considerations 

• Reimbursement applications before patent expiry 

• Launch strategies and "authorised" generics 

Chris Thornham 

Solicitor - Patent & Pharmaceuticals Group 

SJ Berwin LLP, London, UK 

09:20 Recent litigation involving generics and lessons learned 

• Patenting stereochemistry – Warner-Lambert and Lipitor 

• Obviousness – is the test shifting in favour of the Patentee? 

• Patenting polymorphism – Synthon v SKB and Ivax/Arrow v Akzo Nobel 

• Cross border injunctions – GAT and Roche 

Campbell Forsyth 

Sole Practitioner 

Forsyth Simpson, UK 

10:00 The battle for ‘authorised generics’: Is there a future? 

• Benefits for generics companies 

• Benefits for innovator companies 

• Different models 

• How have the FTC, the Department of Justice and the courts been 

treating authorized Generics? 

Steven Lieberman 

Partner 

Rothwell Figg Ernst & Manbeck, PC, USA 

10:40 Morning coffee 

11:10 Overcoming innovator evergreening strategies and techniques to 

extend your patent life 

• Understanding the nature of innovators defensive strategies to maintain 

market growth 

• Learn how to deal with innovators products entry to avoid pitfalls 

• What are the tricks in patent litigation? 

• Assessing the importance of Supplementary Protection Certificates 

(SPC’s) 

Speaker to be confirmed, for more information please visit: 


STREAM D 

BUSINESS DEVELOPMENT STRATEGIES 


Dr Dilip Shah 

Chairman 




08:40 How to manage supply pricing within a European agreement 

• Understand the issue 

• Factors which impact profitability 

• Pan-European supply price requirements 

– Supplier (licensor) 

– Distributor (licensee) 

• Different distribution models in Europe 

• Is there a solution – one price mechanism to suit both supplier and 

distributor? 

Guy Clark 

President 

Glenmark Pharmaceuticals Europe 

09:20 Case study: Techniques to start up a Generic Business in Southern 

Europe 

• Analysis of the current southern European Generic industry landscape 

• Who are the main competitors? 

• Identifying and overcoming potential challenges 

• Organic growth vs. Acquisitions: Pathways, advantages and 

disadvantages for each growth model 

• What are the future opportunities for Generic companies in Southern 

Europe 

Angel Calvo 

General Manager 

Dr Reddy’s Laboratories LTD, Spain 

10:00 Generics R&D in Europe: Challenges and opportunities 

• The dilemma for the smaller generics companies in Europe. 

• Cost effectiveness versus resource availability-where have all the 

formulators gone? 

• Can the CEE provide an alternative to India for outsourcing in Europe? 

• The importance of compatible project management systems in 

outsourced development. 

Malcolm Ross 

Generapharm-Training and Consultancy, Switzerland 

E-mail: registrations@informa-ls.com • Web: www.iir-lifesciences.com/generics • Please quote CQ2134

6th Annual 



11:50 Experiences in implementing the regulatory changes in response to 

the New Medicines legislation implemented in Autumn 2005 

• Review of the latest regulatory changes in Europe 

• When will harmonisation of European legislation for generic medicines 

happen? 

• How is the patient benefiting from these new regulatory changes? 

• What are the future challenges for the national agencies? 

Gabriele Eibenstein 

Head of Division, Drug Regulatory Affairs 

Federal Institute for Drugs and Medical Devices, BfarM, Germany 

12:30 Making the choice between the Mutual Recognition Procedure or the 

Decentralised Procedure 

• Reviewing the key aspects and assessing the pros and cons of the 

Mutual Recognition Procedure and Decentralised Procedure 

• Factors that need to be taken into consideration to make the right 

choice? 

• Which of the procedures has been proven more efficient? And in which 

context? 

Dr. Michel Mikhail 

Director, Head of Regulatory Affairs Europe, CIS & Africa 

Ranbaxy, UK 

13:10 Lunch 

" This event gave a lot of possibilities 

for networking at an executive level" 

Mr Cotting, General Manager, Sochinaz SA 


"Good opportunity for networking and 

update on market trends" 

Pablo Barbero, Area Manager, Chemo Iberica 


14:20 Assessing the increasing acceptance of generics prescribing in general 

practices 

• What do GPs really think about generics? 

• Assessing the level of acceptability by patients of generic medicines 

• Implementing direct patient education to increase the prescription of 

Generics 

• Knowledge and motivation: What makes a GP prescribe generic medicines? 

Dr Roger Bulley 

NHS General Practitioner 

Hamdon Medical Centre, Sommerset, UK 

And Deputy Chair 

British Medical Association GP Prescribing Committee, UK 

15:00 The Plavix battle: Addressing the potentially enormous impact on 

generics and innovators companies 

During this presentation a review of the largest-ever generics launch Plavix 

case will be given and an outline of the outcome and impact on the generics 

industry and innovator companies will be provided. 

Severin de Wit 

IP consultant IPEG, 

The Hague, The Netherlands 

15:40 Afternoon refreshments 

16:00 Counterfeits generics: Is this a problem yet? 

• Overview of the impact and risks created by counterfeited pharmaceutical 

products: What are the challenges for stakeholders? 

• Addressing the emergence of counterfeited Generics: What are the recent 

cases? 

10:40 Morning coffee 

11:10 Responding to a changing world: Overview of the diverse generics 

company models 

• What are the different business models for generics companies? 

• Providing value to patient and providers: differentiating yourself from 

your competitors 

• Licensing and distribution issues 

• Creating added value 

• Changing distribution systems for Generics 

• Why is diversity in the generics portfolio becoming the ideal business 

model? 

• Why do branded and super generics models provide a sustainable 

competitive advantage? 

• Assessing the importance of being globally focused in terms of sales, 

marketing and manufacturing operations 

• Examining the increasing involvement of some companies in 

proprietary product research & development, and in-licensing 

Michael Brückner 

Executive Partner 

Accenture GmbH, Germany 

11:50 Generics market development: Impact on company models 

• Market models 

• Portfolio 

• Product life cycle 

Roberto Terruzzi 

European General Manager 

Almus Pharmaceuticals 

12:30 Opportunities in generic veterinary medicines for human generic 

medicines companies? 

• Veterinary generic’s market dynamics 

• What are the pioneer products? 

• Who are the market leaders? 

• Identifying costs and barriers to entry for human Generics’ companies 

• What is the patent system applied to veterinary Generics in Europe? 

How does it differ from that for human generics? 

• What marketing and sales strategy should be employed? 

• The future of veterinary Generics 

Julian Braidwood 

Managing Director 

Triveritas, UK 

13:10 Lunch 

CLOSING KEYNOTE PRESENTATIONS 

• What are the geographical ‘hotspots’? 

• Developing an effective anti-counterfeiting strategy to minimise risks: What 

can we learn from the innovative pharma industry? 

Max Vetter 

Senior Analyst 

Counterfeiting Intelligence Bureau 

International Chamber of Commerce, UK 

16:40 Overview of the Turkish generics industry and what would be the 

impact of accession to the EU 

• The growing generics market in Turkey 

• Pro's and Con's of current regulatory and IP environment for generics 

industry in Turkey 

• What are the barriers to entry faced by Turkish generics manufacturers 

when selling to Europe 

• Outsourcing opportunities in Turkey 

Zeynep Ulusoy 

Deputy General Manager 

Technical Divisions 

Nobel Ilaç, Turkey 


Dr Dilip Shah 

Chairman 

IGPA, International Generic Pharmaceutical Alliance 



17:30 End of conference 

Book now: Tel: +44 (0)20 7017 7481 • Fax: +44 (0)20 7017 7823

The ever increasing competition in the generics industry and the recent 

involvement of large pharmaceutical groups, are leading generics 

companies to develop innovative growth strategies in the management 

of their product portfolio. 

During this highly interactive workshop, the leaders will help you 

understand how a generics company can be innovative and what 

strategies to implement in order to market and manage your products 

more effectively. 

Key objectives of the Workshop: 

This seminar will address the following topics: 

6th Annual 



Workshop W • Monday 5th February 2007 

How Can Generics Companies Be Innovative? ‘First-to Market’ Strategies and 

Effective Techniques for the Portfolio Management of Generic Products 

• Mastering the regulatory process for approval 

• Adapting to the changing regulatory climate in the EU 

• The challenges generics companies facing in the coming years 

• Overview of the battle between innovative pharmaceutical companies 

and generics companies: How is this evolving? 

• What are the new therapeutic opportunities for the industry? 

• Strategies for effective product portfolio management (PPM) 

• Why do generics companies need to be innovative? And how can this 

be achieved? 

• Increasing and maintaining diversity in the product portfolio 

Registration: 09:30 Start: 10:00 Lunch: 13:00 Afternoon start: 14:00 Finish: 16:30 

Evening Seminar X • Monday 5th February 2007 

Merger & Acquisition Activity within the Generics Market 

• Overview of key sectors trends 

• Outlook for the generics pharma sector 

• What do companies need to do to respond to industry trends 

• M&A as a strategic option 

• Valuation considerations 

• Role of the Investment Bank 

• Case studies 

Led by: 

Registration: 18:00 Start: 18:30 Dinner: 20:00 Finish: 21:30 

Workshop Y • Thursday 8th February 2007 

Legal Briefing for the Generics Industry 

• The European Generic Drug Approval Process: 

- Complying with the new EU registration procedures 

- The harmonisation issue in Europe 

• The EU Bolar Provision 

- Is the EU 'Bolar' Provision Sufficient? 

- How have companies benefited from it? 

• IP and Patent strategies 

- Assessing the impact of the EU expansion 

- The role of the Supplementary Protection Certificate (SPC’s) 

• Regulatory Data Exclusivity 

- Assessing the importance of data exclusivity 

- Strategies to increase the periods of data exclusivity 

- Overview of relevant case studies 

• Are low price and high volume the key drivers? 

• Identifying cost components and their role in pricing 

• The emergence of Biosimilars: what are the opportunities for the 

generic industry? 

Led by: 

Andrew Willis 

European Regulatory Affairs Director 

Cardinal Health, UK 

About your workshop leader: 

Andrew currently works for Cardinal Health, the worlds leading contract 

manufacturer and distributor of pharmaceuticals, where he leads a team of 

internal and external regulatory consultants. A qualified Chemist from the 

University of Glamorgan, he had 8 years experience in manufacturing and 

analysis prior to entering regulatory affairs as a Senior Executive Officer with 

responsibility for submission of European MAA’s and project management of 

development programs. He has extensive experience of project management of 

multinational clinical trials, ensuring co-ordinated compilation of appropriate 

documentation for ethics and regulatory submission throughout Europe. Special 

interests include: • Life-cycle management • 5 years experience 

within EU Generics company • Contract manufacturing - pro-active generic 

developments • 7 years consulting on generic and line-extension applications 

Tommy Erdei 

Executive Director of Healthcare Banking 

UBS Warburg, UK 

About your workshop leader: 

Tommy Erdei, CFA, focuses on mergers and acquisitions in the specialty pharma 

sector at UBS. Tommy has been involved in a large number of transactions in 

the generic sub-sector over the past five years including the recent industry 

transforming acquisition of Matrix by Mylan. 

• Generic Products Launch and Interim Injunctions 

- Implementing successful launch strategies 

- Obtaining/avoiding interim injunctions 

• Pricing and Reimbursement 

- The pricing and reimbursement landscape in the EU 

- What are the major challenges and how can they be overcome? 

• The Impact of Biosimilars 

- Opportunities and challenges for the Generic industry 

- The EU regulatory framework on Biosimilars 

Led by: 

Lorna Brazell 

Partner 

Bird & Bird, UK 

Registration: 09:00 Start: 09:30 Lunch: 12:30 Afternoon start: 14:00 Finish: 16:00 


6th Annual 



Despite the ever increasing competition, there is still 

room for growth in the global generics market! 

Don't miss the opportunity to find out how to grow 

your market share in the global generics industry! 

The 6th Annual Global Generics Strategy Summit 

is the leading generics gathering in Europe. Key 

industry leaders meet each year to share practical 

strategies and solutions to overcome the latest issues 

in the industry. 

2007 Summit key benefits: 

• Design your own agenda by choosing from between 

distinct streams 

• Hear recent effective strategies for the CEOs of the 

most successful generics companies 

• Gain insight into the new business era of biosimilars 

• Learn from generics industry case studies and develop 

new effective business strategies 

• Assess the enormous impact of the Plavix case 

• Learn about trends in pricing and reimbursement for 

generics in the EU and US 

PROMOTIONAL OPPORTUNITIES 

To learn more about our full range of sponsorship or exhibiting 

opportunities please contact Louise Reynolds, Business 

Development Manager, 

Tel: +44 (0) 20 7017 5750 or email: 

louise.reynolds@informa.com 

Raise your corporate profile by sponsoring or exhibiting at this 

event. The 6th Annual Global Generics Strategy Summit will 

represent the most up to date commercial event in Europe on this 

topic, gathering industry and regulatory experts. 

By becoming an event partner, you can: 

• Forge new alliances and joint ventures 

• Launch new products/services and promote existing ones 

• Raise your profile and corporate image 

• Develop new client relationships and affirm existing ones 

Why you can’t afford to miss this conference: 

• Participation from Senior Executives 

Attracting senior Strategic decision makers with top 

level speakers, discussion panels, knowledge sharing 

panels and in depth workshops. 

• Outstanding Networking opportunities 

This event is one of IIR Life Sciences fast growing one, 

each year more participants are joining the conference. 

• Learn the latest Generics Topics 

Hard hitting case studies, take away the best practice 

tips to drive your business 

The venue: Madrid 

Madrid, the capital of Spain, a cosmopolitan city and a 

business center, located in the heart of the peninsula and 

right in the center of the Castilian plain. This marvelous 

city is characterised by intense cultural and artistic activity 

and a very lively nightlife. 

WHO WILL YOU MEET AT THIS EVENT? 

Access to key decision makers worldwide 

6th Annual Global Generic Strategy Summit is the ideal 

platform for your organisation to demonstrate its 

products and services to a targeted and extended 

audience from different sectors of the Generics industry. 

Learn the latest methods being used to design high 

impact business strategy 

Top Delegate Job Titles 2006 

Business Manager 

Regulatory Affairs Director 

Director 

Business Development Manager 

Managing Director 


General Manager 

Vice President 

SUPPORTING PUBLICATIONS 

Book now: Tel: +44 (0)20 7017 7481 • Fax: +44 (0)20 7017 7823 

Eastern Europe 39% 

Other Western Europe 6% 

UK 30% 

Middle East 1% 

Asia 2% 

US 1% 

Southern Europe 11% 

Northern Europe 10% 

Registration Specialist 

Commercial Director 

Medical Director 

Group R&D Director 

Business Strategy Manager 

Purchasing Manager

6th Annual 



2007 Keynote Speakers 

Stephen Stead, Chief Executive Officer, Polpharma, Poland 

Mr Stead, a UK citizen and Pharmacist, has 25 years pharmaceutical industry experience and has held senior leadership 

positions in both with innovative and generic companies, including GlaxoSmithKline, Boehringer Mannheim and Valeant 

(ICN). He has been responsible for running companies in the Central and Eastern Europe area for the past 15 years, most 

recently as CEO for Terapia SA in Romania, which was successfully sold by Advent International to Ranbaxy in June. Mr Stead 

is currently the new Chief Executive Officer of Polpharma, the Polish market leader by volume of medical drugs. He will bring 

his experience to Polpharma, in order to accelerate the companies expansion into the fast growing regional markets and to 

consolidate its leadership of the Polish market. 

Dr Brian Tempest, Chief Mentor & Executive Vice Chairman of the Board, Ranbaxy, India 

Dr. Brian W. Tempest has worked in the Pharmaceutical Industry for over 33 years and is widely regarded for his vast domain 

knowledge and experience in managing operations in Emerging markets, Europe, Japan and the USA. Dr. Tempest joined 

Ranbaxy in 1995 as Regional Director, Europe, CIS and Africa. In January 2000 he was promoted as Worldwide President - 

Pharmaceuticals, based in India. He was subsequently inducted on the Board of Directors of the company. In December 2003, 

he was elevated to the rank of “Joint Managing Director and CEO Designate”. Dr. Tempest assumed his current role of “CEO 

and Managing Director” on July 5, 2004. During the initial 14 years of his prolific career, Dr. Tempest worked for Beecham 

and GD Searle in a variety of roles in Sales, Marketing and Country Management, primarily in the UK. In 1985, he joined 

Glaxo Holdings as Regional Director responsible for the Far East Region, including Japan, China, Korea, Taiwan, Africa and 

the Middle East Region. In 1993, Dr. Tempest joined Fisons plc and became its Worldwide Commercial Operations Director, 

managing all 40 Country Operations. Dr. Tempest holds a PhD in Chemistry from Lancaster University. He is an active 

participant at global healthcare conferences and a familiar speaker at many international medical forums. 

Dr Dilip Shah, Chairman, IGPA, International Generic Pharmaceutical Alliance and Secretary 

General, Indian Pharmaceutical Alliance, India 

Dilip Shah is the CEO of Vision Consulting Group, a firm specialised in strategic planning and has 37 years’ varied experience 

in the pharmaceutical industry. 

In addition, he currently holds the following positions: 

Chair of the Management Board of the International Generic Pharmaceutical Alliance (IGPA) 

Secretary-General of the Indian Pharmaceutical Alliance (IPA), an Association of 13 large research based national companies. 

Together they share 30 per cent of the domestic market, account for one-third of exports and contribute 90 per cent of R & D 

spending in the pharmaceutical industry 

Member, The World Bank Generics Consultative Group 

Co-chairman of the FICCI's Committee on Pharmaceuticals 

Member of the Board of Advisors of: 

- Express Pharma Pulse (Weekly) 

- Pharmabiz.com (Weekly) 

Member of the Advisory Panel for the Business Briefing: PharmaGenerics, U.K. 

Editor, Asia and India, Journal of Generic Medicines, U.K. 

Tim Oldham, VP Business Planning and Operations Effectiveness, Mayne Pharma, UK 

Tim Oldham joined Mayne Pharma in 2002 as Global Projects Manager to lead Mayne’s entry into biosimilars. In 2003 he 

moved to Europe as Director of Business Development and Strategic Marketing, building deeper relations with the biosimilar 

industry and ultimately leading the deal team that closed Mayne’s joint development and marketing agreement for EPO and G- 

CSF with Pliva in February 2005. Since then he has been a member of the Joint Development Committee and led the Mayne 

implementation team. Tim is also a member of the European Generic Medicines Association (EGA) Executive and Chairman 

of the EGA’s Biosimilars and Biotechnology Committee. He was a member of the Program Committee for the EMEA/DIA 

Biosimilars Workshop in Paris in late 2005 and led the biosimilar industry delegation at that workshop. He has spoken widely 

on biosimilars issues. Prior to joining Mayne, Tim was a consultant with McKinsey & Company in Australia. He holds a PhD 

in chemistry (photodynamic therapy) from Imperial College in London and Honors’ degrees in Science (chemistry) and Law 

(intellectual property) from the Australian National University in Canberra. 

Jonas Tryggvason, Executive Vice President, Central and Eastern Europe & Asia Sales, Actavis 

Group, UK 

Mr Tryggvason has 15 years of extensive experience in business development on the international market. Working in sales, 

marketing and management at locations in USA, Iceland, Bulgaria and Russia. He has obtained wide knowledge of business 

cultures in the Eastern Europe and the Pacific area. Recognised for being quick to get the big picture and move things forward. 

From 2004 to 2005, Mr Tryggvason was the Actavis Group Regional Director (Russia, Ukraine & CIS) and Head of Actavis 

Representative Office in Moscow. Since December 2005, he is currently the Executive Vice President at the Actavis Group 

(CEEA Sales). 


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Tel zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz Fax zxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

Booking Contact: zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 


Tel zxzxzxzxzxzxzxzxzxzxzxzxzxz Fax zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

Name of Company zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

Department zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

Address zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz City zxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

Postcode zxzxzxzxzxzxzxzxzxzxzxzxzxzxz Country zxzxzxzxzxzxzxzxzxzxzxzxzxz 

Tel zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz Fax zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

Nature of Company Business zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz 

No. of employees on your site: 1) 0-49 �� 2) 50-249 �� 3) 250-499 �� 4) 500-999 5) 1000+ �� 

Terms and Conditions 

FEE: This includes all technical sessions, lunch and documentation. 

CANCELLATIONS: Cancellations received in writing before and on 22 January 

2007 will be subject to a service charge of £99. The full conference fees remain 

payable after 22 January 2007. Substitutions are welcome at any time. 

It may be necessary for reasons beyond the control of the organiser to alter the 

content and timing of the programme or the identity of the speakers. In the 

unfortunate event that an event is cancelled Informa are not liable for any costs 

incurred by delegates in connection with their attendance. This contract is subject 

to English Law. 

ARE YOU REGISTERED?: You will always receive an acknowledgement of your 

booking. If you do not receive anything, please call us on 

+44(0) 20 7017 7481 to make sure we have received your booking. 

ANY SPECIAL REQUIREMENTS: 

Please inform us if you have any special requirements by calling 

Customer Services on +44(0) 20 7017 7481. 

DATA PROTECTION: 

Telephone calls to Informa Life Sciences Ltd may be recorded or monitored in 

order to check the quality of the service being provided. 

The personal information shown on this fax, or provided by you, will be held on a 

database and may be shared with companies in Informa Life Sciences. They may 

be used to keep you up-to-date with developments in your industry. We believe 

that you are the correct person to receive details of conferences connected with 

this subject. Sometimes your details may be obtained from, or made available to 

external companies for marketing purposes. If you do not wish your details to be 

used for this purpose, please contact 

Tel: +44 (0) 20 7017 7077 Fax: +44 (0) 20 7915 5001 

Personal data is gathered in accordance with the Data Protection Act 1998. Your 

details may be passed to other companies (in countries within or outside the 

EEA) who wish to communicate with you about offers related to your business 

activities. 

Conference Code: CQ2134C 

Pre-conf Workshop Code: CQ2134W 

Pre-conf Evening Seminar Code: CQ2134X 

Post-conf Workshop Code: CQ2134Y 

6 Easy ways to Register 

+44(0) 20 7017 7481 

+44 (0) 20 7017 7823 

registrations@informa-ls.com 

STEP 1 DECIDE WHAT YOU WANT TO ATTEND (for more than one delegate please photocopy this form) 

Please register me for: 


The Bookings Department 

Informa UK Ltd 

P O Box 406 

Byfleet 

KT14 6WL 

Group Bookings: To take advantage of group bookings 

please contact Simon Lau, Tel: +44(0)207 017 7165 

email simon.lau@informa.com 

■ Monday 5th February 2007 Full-day Pre-Conf Workshop W CQ2134W 

■ Tuesday 6th – Wednesday 7th February 2007 Two-day Conference CQ2134C 

■ Monday 5th February 2007 Pre-Conf Evening Seminar X 

STEP 2 WORK OUT THE PRICE 

CQ2134X 

■ Thursday 8th February 2007 Post-Conf Workshop Y CQ2134Y 

Event selection 

Code 

Book before 15th December Save Book before 

Save Book after 

Save 

2006 

12th January 2007 

12th January 2007 

Full Pass 

CQ2134C/W/X/Y �� £3096 + VAT 16 % = £3591.36 £500 �� £3196 + VAT 16% = £3707.36 £400 �� £3296 + VAT 16% = £3823.36 £300 

Conference plus Pre-Conf and Post-Conf Workshops W & Y CQ2134C/W/Y �� £2597 + VAT 16% = £3012.52 £400 �� £2697 + VAT 16% = £3128.52 £300 �� £2797 + VAT 16% = £3244.52 £200 

Conference plus One Workshop W or Y and Seminar X CQ2134C/W or Y/X �� £2397 + VAT 16% = £2780.52 £400 �� £2497 + VAT 16% = £2896.52 £300 �� £2597 + VAT 16% = £3012.52 £200 

Conference plus Workshop W or Y 

CQ2134C/W or Y �� £1898 + VAT 16% = £2201.68 £300 �� £1998 + VAT 16% = £2317.68 £200 �� £2098 + VAT 16% = £2433.68 £100 

Conference plus Pre-Conf Evening Seminar X 

CQ2134C/X �� £1698 + VAT 16% = £1969.68 £300 �� £1798 + VAT 16% = £2085.68 £200 �� £1898 + VAT 16% = £2201.68 £100 

Conference only 

CQ2134C �� £1199 + VAT 16% = £1390.84 £200 �� £1299 + VAT 16% = £1506.84 £100 �� £1399 + VAT 16% = £1622.84 

Great academic rates available. Contact Simon Lau on +44 (0)20 7017 7165 or e-mail: simon.lau@informa.com for further details 

Are we mailing you correctly? To update your contact details on our database please email integrity@informa.com 

DELEGATE DETAILS – Please photocopy form for multiple bookings! PAYMENT INFORMATION 

(Mr/Mrs/Ms/Miss/Dr) Family Name zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz �� Please invoice 

Forename zxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxzxz �� Credit Card. Please debit my: �� ) �� z �� y 


Card No: �� 

Expiry Date: .................................................................................................. 

Signature: .............................................................................................................. 

Credit card billing address: 

............................................................................................................................ 

............................................................................................................................ 

Contact Number for Card Holder: 

............................................................................................................................ 

Please note that cards will be debited within 7 days of your registration on 

to the conference 

�� Yes I agree to the terms and conditions as stated on this form. 

Delegates who do not pay with their booking are requested to provide a copy of bank transfer 

/ credit card / cheque details to help payment allocation. Staff at the event will request a credit 

card guarantee for delegates without proof of payment. 

Venue Details: 

Hotel NH Eurobuilding 

Calle Padre Damian 23 

28036, Madrid, Spain 

Tel: +34 91 353 73 00 

Fax: +34 91 359 00 17 

Reduced Rate Hotel Accommodation: 

The cost of the accommodation is not included in the conference fee. Reduced rate 

accommodation can be arranged for you as a free service to IBC delegates by contacting IBR on 

Tel: +44 (0)1332 285590; email at informa@ibr.co.uk or web: www.ibr.co.uk/informa 

Conference Documentation: Cannot Attend? 

For those busy executives who cannot take full advantage of this event, the papers 

give you a useful record of the presentations made at the event. The set of speakers 

papers and/or slides from the conference is available after the event for £299. 

Contact Customer Services on tel: +44(0) 20 7017 7481, fax: +44 (0) 20 7017 7823 

or e-mail: registrations@informa-ls.com

39614 Global Generics - SJ Berwin

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