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SMi Introduce their 15th Annual Generics, Supergenerics and Patent Strategies Conference:

The pharmaceutical generics industry is a fast moving and consistently expanding one. With the much referenced patent cliff rapidly approaching for many and already passed for some all businesses are looking to generics for a source of additional revenue.

For the big Parma companies these generics ventures are interesting diversification opportunities to add to their portfolio. For the generics companies themselves there is an opportunity to partner up with these industry heavyweights and perhaps make the most of the partnerships to launch new branded generics which may have the potential to become best sellers in their own right.

Along with the opportunities generics offer there is also a minefield of IP and patent issues along with regional regulations and marketplace differences to contend with before you can get your products to market.

SMi's conference will provide you with an excellent overview of the industry at the moment. You will hear case studies from the big players in the market showing how they have handled issues and how they see the industry moving forward. We will also be covering some of the current regulatory issues and also the big Parma perspective of their movements in the generic field.

Key Reasons to Attend:

Hear from expert speakers on the current state of the Generics markets.
Discuss strategies for making the best use of branded and super-generics.
Analyse the recent trend of Big Pharma moving into the Generics field.
Learn about recent Generics case law and how the outcomes affect your business.
Network
with senior representatives and key decision makers within Generics.

 

 

Chief Executives, Executive Directors, Vice Presidents, Heads, Team Leaders of:

  • Intellectual Property
  • Regulatory Affairs
  • Business Development
  • Licensing
  • Manufacturing
  • APIs
  • Market Strategy
  • Legislation and Policy Advice
  • Drug and Safety Assessment

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9:10 A Global Outlook for the Generics Industry: from Commodity to Value Added Generics

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • An overview of global generics investments and the next level of development in generic drugs
  • Trends and the future market environment – how will this hinder or enhance growth and profitability?
  • What are the main opportunities and/or threats which are pushing entry into this intensely competitive industry?
  • How will the industry change with increased competition faced by new entrants?
  • 9:50 Branded generics and emerging market- why all the fuss?

    Paul Mendelsohn

    Paul Mendelsohn, Managing Director, Pharmawise

  • What are the effects of recent changes to generics regulations
  • Open healthcare reforms and their impact.
  • Overview of recent litigation
  • 10:30 Morning Coffee

    11:00 An update on European case law

    Paul Csiszar

    Paul Csiszar, Director, European Commission

  • What are the effects of recent changes to generics regulations
  • Open healthcare reforms and their impact.
  • Overview of recent litigation
  • 11:40 Moving into new countries: European market profiling

    Ewan Livesey

    Ewan Livesey, Senior Vice President Corporate Development, Country Manager Switzerland, Lupin (Europe) Ltd

  • What makes a market attractive?
  • Will your business model fit a new market?
  • Risk management of forays into new regions
  • Acquisition vs. Start up
  • 12:20 Networking Lunch

    14:00 A future perspective of the UK generics market

    Rex Clements

    Rex Clements, Country Head UK, Sandoz Biopharmaceuticals

  • How long can the UK maintain the current levels of generic competition?
  • What can companies who operate in the UK do to profit from this market?
  • Forecasts for the future of the UK generics market
  • 14:40 How can smaller companies survive in the European generics industry?

    Guy Clark

    Guy Clark, Strategic Business Development, Mercury Pharma

  • Pressures facing the generics industry
  • Competitive advantages of small and large companies
  • Opportunities for smaller organisations
  • Outlook for the future of the European generics industry
  • 15:20 Afternnon Tea

    15:50 Effects of Chinese companies entering European markets

    Bruce Murdoch

    Bruce Murdoch, Commercial Director, Stravencon Ltd

  • How will these moves impact the already saturated markets?
  • What advantages to Chinese companies have that makes them believe they can succeed in foreign markets?
  • Will Chinese companies look to partner with existing operations in Europe?
  • 16:30 Q&A with chairman and selected speakers

    17:00 Chairmans Closing Remarks and End of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

    9:10 Assessment of the growing trend of big pharma moving into generics

    Alan Sheppard

    Alan Sheppard, Global Head Generics, Thought Leadership, IMS Health

  • Why are innovators showing an active interest in the generics market?
  • What are the obstacles that stand in their way?
  • Is the model of big pharma suited to the generics industry?
  • What effect will this movement into an already competitive market place have on existing generics companies?
  • 9:50 Can partnerships between big pharma and generics companies work?

  • Procedural issues where management conventions clash
  • What aspects of partnerships are the most valuable and how can they be enhanced
  • A look at the profiles of recent collaborations and what they have achieved
  • Yariv Hefez

    Yariv Hefez, Director Global Business Development & Alliance Management, Merck Serono International S.A.

    Paul Mendelsohn

    Paul Mendelsohn, Managing Director, Pharmawise

    Bruce Murdoch

    Bruce Murdoch, Commercial Director, Stravencon Ltd

    10:30 Morning Coffee

    11:00 Patent settlement agreements a generic standpoint

    Sean-Paul Brankin

    Sean-Paul Brankin, Partner, Crowel & Moring

    What are the relevant principles and potential pitfalls?
    How do recent developments affect how generics companies approach patent disputes in the future?
    What strategies are available to avoid concerns?

    11:40 Efficient European Regulatory Maintenance for Generics

    Nick Littlebury

    Nick Littlebury, Regulatory Affairs Manager, Diamond Pharma Services

  • How to reduce the regulatory burden
  • Strategic options and innovative approaches for variation submissions
  • License and documentation organisation: A best practice guide
  • 12:20 Networking Lunch

    13:40 Recent developments in supplementary patent certificates

    Duncan Curley

    Duncan Curley, Director, Innovate Legal

  • What is the criteria for being awarded an SPC?
  • What effect have recent IP and patent rulings had on the industry?
  • A look at recent and ongoing cases
  • 14:20 European Generics Regulations

    John Warren

    John Warren, Director, Medicines Assessment Ltd

  • Are simple generics simple?
  • What are chemisimilars?
  • The importance of assay sensitivity
  • Trends for biosimilar guidance
  • 15:00 Practical aspects of patent strategies for Generics/Supergenerics

    Julie Barrett-Major

    Julie Barrett-Major, Director of Intellectual Property, Norgine Ltd

  • Avoiding icebergs: spotting/circumventing barriers to market access
  • Erecting fences: keeping competition at bay
  • Managing conflicting issues (e.g publications v. protection)
  • Practical teamwork: who needs to know/be consulted
  • 15:40 Chairmans Closing Remarks and End of Day One

    15:50 Afternoon tea

    +

    Workshops

    Innovative Regulatory Strategies for Generics
    Workshop

    Innovative Regulatory Strategies for Generics

    Copthorne Tara Hotel
    16th May 2012
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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