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Official Conference Sponsor :
Generics '99
1999's most important update on the international generics market

22 - 24 September 19999, Le Meridien, Brussels, Belgium
       Save GBP100.00 When You Book Both Events!!       

Whether you represent the generics industry or an R&D company - You can not afford to miss this .... R&D companies must attend this event. Only by being fully informed of the current developments in the generics industry can you hope to counter the impact of sustained generic market growth and penetration

Stark economic realities continue to dictate the pace of reforms for the international Healthcare Industry. The industry has constantly had to grapple with a shifting customer base, downward pressure on prices by Governments and Health agencies and a less than certain regulatory and intellectual property environment.

The 1999 Global Generics Meeting will comprehensively review the International Market for Generic Drugs and will give companies practical advice from renowned experts on how to compete in this increasingly competitive environment.

Adapt strategies for successful sourcing of active pharmaceutical ingredients in a dynamic market The pressures of growing competition, emerging supplier markets and increasing regulatory requirements for active pharmaceutical ingredients (API), are resulting in increasingly complex sourcing decisions.

Generic companies, facing increasing competition - need to find the cheapest source of APIs but need to ensure reliability and quality.

Pharmaceutical innovator companies look increasingly to outsource API production as they concentrate on their core competencies.

This conference, with a speaker panel drawn from leading API manufacturers, Generics companies and industry experts, offers a superb opportunity for discussion of the current issues affecting the market.

Speakers will share their knowledge gained from extensive experience in this field, evaluating the alternative sourcing options, giving practical advice for all those involved in the strategic management of production and procurement of APIs

Between now and 2002, the patents of approximately 120 major branded pharmaceuticals will expire, including the blockbusters omeprazole, enalapril and fluoxetine. Such patent expiries offer a huge opportunity to Generic Drug Manufacturers - will your organisation be one of the winners in the race for commercial advantage?
This conference will enable you to
  • Gain an in-depth view of the global generics market from country experts
  • Identify current trends and how these will impact on your business
  • Understand the current developments in IP and how they impact upon both sides of the market
  • Protect and extend the life cycle of your product
  • Assess the impact of pricing and reimbursement policies on the generic drug market
  • Establish how far should reimbursement policies influence your global strategy
  • Clarify the current regulatory requirements for products in the major generics markets
  • Network, network, network
Official Publication and Sponsor
International Journal of Generic Drugs.
For Additional Details Contact Locum International
www.locumUsa.com
www.locumEuro.com
www.locum.co.il
Fax: +972-97-494-532 Email:


Other Publications
International Journal of Drug Development



   
Agenda for Generics '99
22 - 24 September 19999, Le Meridien, Brussels, Belgium

Day One
Wednesday 22rd September

| DAY ONE| DAY TWO| STRATEGIC SOURCING OF APIS|
Chair: Ian Senior
Special Advisor
National Economic Research Associates (NERA), UK
09.00 Registration and coffee
09.30 Opening remarks from the Chair
09.40 The international healthcare market and the role of generic drugs
  • Examining developments in the generics market over the last ten years
  • A macro view of pharmaceutical revenues over the next ten years
  • Opportunities/imperatives for the generics pharmaceutical industry
    Graham Lewis
    Managing Director
    IMS Strategic Global Solutions, UK
  • MARKET REVIEWS
    Developing markets for generic products: Assessing the opportunities offered by low price countries
    10.20 Spain
  • Conditions imposed on EFGs
  • The patent system
  • Generic substitution
  • Reference product requirements
  • Reference pricing
    Jordi Faus
    Faus & Molliner, Spain
  • 11.00 Morning coffee
    11.30 Italy
  • Overview of Italian healthcare system
  • Pricing systems in Italy
  • Opportunities in the generic medicines market
  • Strategies for success in the Italian generic market
  • The future of the market Dr Hilke Baasch Pharmaceutical Development Manager
    Bracco, Italy
  • 12.10 France
  • Overview of French healthcare system and potential changes
  • Assessing the potential of the generics market, identifying market drivers
  • Strategies for growth
  • Evaluating the future direction of the French generic market
    Jean Michel Peny
    Vice President
    ISO Health Care Group, France
  • 12.50 Lunch
    Emerging markets for generic products: Opportunities for growth
    14.00 South Africa Market segmentation and specific opportunities for generics in the South African market
  • Demographics
  • Patent issues
  • Registration issues
  • price evolution generic versus originator
  • value and volume relationships in different segments
    Ignatius M Viljoen
    Former CEO
    Rolab, part of Novartis, South Africa
  • 14.40 India
  • Evolution of the Indian market
  • Status of intellectual property laws
  • Strategy of leading Indian companies
  • What next for the Indian market?
    Brian Tempest
    Regional Director, Europe, CIS and Africa
    Ranbaxy, UK
  • 15.20 Afternoon tea
    Established markets for generic products
    15.50 USA Clarifying recent changes to generic registration in the USA
  • Individual versus average bioequivalence
  • Update on FDA initiatives with regard to implication of ICH
  • Site specific stability and the Draft Stability Guidance
  • Draft impurities guidance
  • SUPAC/BACPAC update
  • Blend uniformity
  • Guidance for non absorbed drug dosage forms
  • Electronic ANDA submissions
    Deborah Miran
    Miran Consulting Inc, USA
  • 16.30 USA 180 day generic market exclusivity ­ Current status and strategic implications
    Andrew Berdon
    Vice President and General Counsel
    Purepac Pharmaceutical Company, USA
    17.10 Canada
  • Overview of the Canadian generics market - the players, the market, the payers, the trends
  • Legal position of the market
  • Future trends and opportunities
    Judy Gold
    Director, Purchasing
    Novopharm, Canada
  • 17.50 Closing remarks from the Chair
    18.00 You are invited to join us for a drinks reception where you will have the opportunity to talk with speakers, fellow delegates and exhibitors
    18.30 Close of day one

    Day Two
    Thursday 23rd September

    | DAY ONE| DAY TWO| STRATEGIC SOURCING OF APIS|
    Chair: Ian Senior
    Special Advisor
    National Economic Research Associates (NERA), UK
    09.00 Morning coffee
    09.10 Opening remarks from the Chair
    STRATEGIC ISSUES
    09.20 Assessing the advantages and disadvantages of entering into the generics market
  • Factors involved in the decision making process
  • Product portfolio: where does the potential for generics lie?
  • Requirements and needs of a successful generics business
  • Identifying the business benefits of opting out
    Norbert Bangert
    Manager Generics
    Bayer AG, Germany
  • 10.00 The legal framework for generic drugs
  • Single trademark requirement
  • Packaging and labelling guidelines
  • Roche Bolar exemption ­ the status in Europe
    Stephen Kon
    S J Berwin, UK
  • 10.40 Morning coffee
    11.10 Pricing and reimbursement policies and their influence on the generics market
  • Drivers for in-patent, generic and non-prescription medicines
  • Role of government, health funds, doctors and patients
  • Will a 'fourth hurdle' for new research-based medicines benefit generics?
  • How could the impact of a Bolar exemption be measured?
    Ian Senior
    Special Advisor
    National Economic Research Associates, NERA, UK
  • REGULATORY ISSUES
     Chair: 
    Tony Cartright
    Senior Director, Regulatory Affairs
    Parexel International Ltd, UK
    11.50 Developing a strategy to facilitate successful mutual recognition applications despite the lack of harmonisation
  • Assessing the future use of the mutual recognition procedure for generic applications
  • Opportunities made available by the ECJ ruling
  • Constraints and opportunities set by the Commission communication
    John McGuire
    Parexel International Ltd, UK
  • 12.30 ICH and its impact on the generic pharmaceutical industry
  • Current status of ICH initiative
  • Future ICH developments
  • ICH specifications guidance
  • The Common Technical Document
  • Implications for the generic pharmaceutical industry
    David Parsons
    Head of Group Regulatory Affairs
    Stafford Miller Ltd, UK
  • 13.10 Lunch
    14.30 Speeding up the registration process through effective bioequivalence studies
  • Selecting the most appropriate comparator product
  • Varying European requirements
  • Bioequivalence for modified/slow release products
    Christopher Kirkpatrick
    Associate Director, Phase I Research
    Chiltern International, UK
  • 15.10 Assessing the progress towards a globally recognised comparator product
  • Current national comparator products
  • Deciding on the selection criteria used in assessment
  • Working towards an international list of comparator products
  • How close are we?
    Juhan Idanpaan Heikkila
    Special Advisor for Quality Assurance and Safety of Pharmaceuticals, Health Technology and Drugs
    World Health Organisation, Switzerland
  • 15.50 Closing remarks from the chair
    16.00 Afternoon tea
    16.30 Close of conference

    24th September 1999 ­ Brussels, Belgium
    Strategic Sourcing of Active Pharmaceutical Ingredients For Competitive Advantage

    | DAY ONE| DAY TWO| STRATEGIC SOURCING OF APIS|
    Chair: Jean Hoffman
    President
    Newport Strategies Inc, USA
    09.00 Registration and coffee
    09.20 Opening remarks from the Chair
    09.30 Understanding the driving forces shaping the API industry and assessing future scenarios for the sourcing of APIs
  • Assessing the impact of changing pressures from the brand and generics companies on the API market
  • What implications does the growth of the Asian API markets have on the industry?
  • Implications of increased competition
  • Increased regulation of APIs
  • Identifying and capitalising on opportunities in the changing API market
  • What does the future hold for the international API market?
    Enrico Polastro
    Arthur D Little, Belgium
  • 10.10 Competitive advantage through strategic sourcing of APIs ­ Which comes first, sourcing or marketing decisions
  • How product marketing and development choices interconnect with sourcing
  • Targeting profitable products through competitive analysis of APIs
  • Impact of API availability on generic pricing: Lessons from Mylan
  • Future scenarios: Wil
  • bloodbaths or niche products predominate?
  • Impact of brand trends on API availability
    Jean Hoffman
    President
    Newport Strategies Inc, USA
  • 10.50 Morning coffee
    11.20 Auditing potential API suppliers: getting the facts for the best choice
  • Identifying potential future suppliers
  • Thinking strategically to ensure you make the right choice
  • Avoiding common pitfalls in the selection of a supplier
  • Obtaining reliable information, ensuring the right questions are asked
  • Managing price over the life cycle of a product ­ what is a good price?
    Tom Buggy
    Vice President Quality Operations
    Hovione SA, Portugal
  • 12.00 A generic companies perspective on effective sourcing of APIs
  • Examining the drivers behind generic companies sourcing decisions
  • Identifying potentia
  • sources
  • Single versus multiple sourcing
  • Finding and selecting suitable suppliers
  • Ongoing audits to ensure standards are maintained
  • Minimising supply risks
  • Planning ahead for future demands of the generics industry
    Speaker to be confirmed
  • 12.40 Lunch
    14.00 Examining the current status of intellectual property (IP) protection and patent legislation and its implications for sourcing APIs
  • Clarifying the current patent laws, the differences and their implications for APIs and generics in the US and Europe ­ product, process and formulation patents
  • GATT/TRIPS and their impact currently on IP protection in Asia
  • Clarifying the use of Supplementary Protection Certificates and their impact for the sourcing of APIs
  • Update on the Bolar Amendment and progress in Europe
  • Ensuring your supplier isn't infringing patents
    Morag Macdonald
    Bird & Bird, UK
  • 14.40 Maximising the potential of China as a source of APIs
  • Overview of the Chinese pharmaceutical industry
  • Trends in the Chinese pharma market
  • Quality and regulatory compliance
  • Exploring the potential for alliances and co-operative agreements
  • Critical success factors for sourcing from India
    Susan Capie
    General Manager
    PDM Pharmatec Ltd, USA
  • 15.20 Proposed guideline for GMP of APIs and EC Draft Directive on GMP for starting materials and inspections
  • Assessing the current proposals for ICH Q7: manufacturing, processing, packaging and storage of APIs
  • Examining currently unresolved issues
  • Estimated timeframe for the completion and implementation of ICH Q7
  • Forerunners of the draft directive on GMP for starting materials and inspections
  • Implications of the current scope
  • Timetable for the implementation of the directive
    Norman Franklin
    Interactive, UK
  • 16.00 Closing remarks from the Chair
    16.10 Close of conference Afternoon tea will be served

    Official Publication and Sponsor
    International Journal of Generic Drugs.
    For Additional Details Contact Locum International
    www.locumUsa.com
    www.locumEuro.com
    www.locum.co.il
    Fax : +972-97-494-532 Email:


    Other Publications


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