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Generics and Patent Strategies 2013
13 May - 14 May 2013
Generics and Patent Strategies 2013

Join SAE Media Group for their 16th annual conference on Generics and Patent Strategies to be held in central London on 13th-14th May 2013. This event never fails to disappoint and will address the hottest topics and key challenges faced within the Generics industry today. Presentations and panel discussions hosted by some of the key opinion leaders within the field of generics will provide delegates with the opportunity to address the challenges faced both today and tomorrow. This year’s event tackles some of the regulatory challenges experienced when entering new markets. It will explore how to overcome some of the IP issues faced when challenging patents and takes a detailed look at the pricing pressures surrounding an already saturated marketplace.

It is undoubtedly a highly competitive industry and with some of the large innovator companies searching for a piece of the Generics pie, SAE Media Group’s 16th annual conference will provide the perfect opportunity to share, discuss and develop new strategies in order to overcome some of the issues faced within a highly competitive marketplace. This year’s agenda provides a truly comprehensive overview of the generics landscape and facilitates the formation of new partnerships and networking opportunities to better position our attendees moving forward.

FEATURED SPEAKERS

Bernd Stoiber

Bernd Stoiber

Head of Branded Generics, AstraZeneca
John Warren

John Warren

Director, Medicines Assessment Ltd
Martin Paltnoi

Martin Paltnoi

Senior Consultant, MPA Business Services Ltd
Paul Csiszar

Paul Csiszar

Director, European Commission
Warwick Smith

Warwick Smith

Managing Director, BGMA

Alan Sheppard

Global Head Generics, Thought Leadership, IMS Health
Alan Sheppard

Bernd Stoiber

Head of Branded Generics, AstraZeneca
Bernd Stoiber

Chetak Buaria

Director, Alliance Management, Merck Serono International S.A.
Chetak Buaria

Dimitris Roukounas

European Patent Attorney,
Dimitris Roukounas

Duncan Curley

Director, Innovate Legal
Duncan Curley

John Warren

Director, Medicines Assessment Ltd
John Warren

Martin Paltnoi

Senior Consultant, MPA Business Services Ltd
Martin Paltnoi

Nick Littlebury

Regulatory Affairs Manager, Diamond PV Services
Nick Littlebury

Nicola Travierso

General Manager, ntc pharma
Nicola Travierso

Paul Brady

Patent Attorney, Abel and Imray
Paul Brady

Paul Csiszar

Director, European Commission
Paul Csiszar

Paul Mendelsohn

Managing Director, Pharmawise
Paul Mendelsohn

Paul Mendelsohn

Managing Director, Pharmawise
Paul Mendelsohn

Peter Wittner

Senior Consultant, Interpharm Consultancy
Peter Wittner

Pieter Dylst

Financial reporting , Research Centre for Pharmaceutical Care & Pharmaco-economics
Pieter Dylst

Rahul Garella

Senior Vice President - EU Business, Glenmark Generics (Europe)
Rahul Garella

Simon Cohen

Partner, Taylor Wessing
Simon Cohen

Warwick Smith

Managing Director, BGMA
Warwick Smith

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Bernd Stoiber

Bernd Stoiber, Head of Branded Generics, AstraZeneca

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9:10

Moving into new markets: industry trends

Paul Mendelsohn

Paul Mendelsohn, Managing Director, Pharmawise

  • Attractive markets: are there any left
  • Is there still room for smaller companies
  • Indentifying new opportunities: are Biosimilars the answer
  • Challenges of Dwindling Pharmaceutical Innovator products
  • clock

    9:50

    The allure of Generics for Big Pharma

    Peter Wittner

    Peter Wittner, Senior Consultant, Interpharm Consultancy

  • Why the increasing trend of 'Big Pharma' enterring the market?
  • Obstacles 'Big Pharma' have to overcome in order to enter the Generics industry
  • Implications of 'Big Pharma' enterring the market
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    10:30

    Morning Coffee

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    11:00

    Recent Developments in Antitrust Enforcement in the Pharma Sector

    Paul Csiszar

    Paul Csiszar, Director, European Commission

  • Overview of the Commission's current enforcement activities
  • Update on Patent Settlement monitoring
  • Interaction between Regulatory and competition issues 
  • clock

    11:40

    Strategic Regulatory Affairs and your options in Europe

    Nick Littlebury

    Nick Littlebury, Regulatory Affairs Manager, Diamond PV Services

  • Validation Strategies
  • Application routes: The pro's and con's
  • Regulatory Strategies and tools for Commercialisation

     

  • clock

    12:20

    Panel Discussion: Should the Generics industry be looking to Biosimilars?

    Chetak Buaria

    Chetak Buaria, Director, Alliance Management, Merck Serono International S.A.

    Peter Wittner

    Peter Wittner, Senior Consultant, Interpharm Consultancy

    John Warren

    John Warren, Director, Medicines Assessment Ltd

    Warwick Smith

    Warwick Smith, Managing Director, BGMA

    clock

    13:00

    Networking Lunch

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    14:00

    Using Patent litigation to acheive a First-to Launch Generic

    Duncan Curley

    Duncan Curley, Director, Innovate Legal

  • Why Litigate?
  • Need for coherent regulatory and litigation strategy
  • Infringement and patent nullity claims- pro's and con's
  • How much does it cost?
  • clock

    14:40

    Value Added Generics: Assessing the market

    Nicola Travierso

    Nicola Travierso, General Manager, ntc pharma

  • Where are the most successful markets?
  • What therapy areas have proven most successful?
  • Government policies and there effects on Value Added Generics
  • Considering Patent Strategies
  • clock

    15:20

    Afternoon Tea

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    15:40

    Recent Case Law Related to European Patents and Suplementary Protection certificates for pharmaceutical products (SPC's)

    Dimitris Roukounas

    Dimitris Roukounas, European Patent Attorney,

  • Decisions of the Boards of Appeal of the European Patent Office
  • SPC decisions of the Court of Justice of the EU
  • Impact on the dvelopment of patent Strategy
  • clock

    16:20

    SPC's and all that

    Martin Paltnoi

    Martin Paltnoi, Senior Consultant, MPA Business Services Ltd

    clock

    17:00

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Rahul Garella

    Rahul Garella, Senior Vice President - EU Business, Glenmark Generics (Europe)

    clock

    9:10

    Branded Generics: employing Commercial Strategy

    Bernd Stoiber

    Bernd Stoiber, Head of Branded Generics, AstraZeneca

  • What is a Branded Generic?
  • Making Quality Branded Generics accessible
  • Penetrating emerging markets: Developing your Business Model
  • Understanding your customer and translation to increased sales
  • clock

    9:50

    Do Branded Generics Make a Difference

    Alan Sheppard

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

  • Perception and differences between Branded Generics and Commodity Generics: Safety, efficacy and quality
  • Emerging Markets perception of Branded Generics
  • Strategies to launch in Emerging markets
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Generics in Europe … the beginning or the end?

    Rahul Garella

    Rahul Garella, Senior Vice President - EU Business, Glenmark Generics (Europe)

  • Relentless cost containment and its impact
  • Emergence of Differentiated business models
  • NTE's- a new look at old molecules
  • Marching in step: How companies are re-aligning to the new business reality
  • clock

    11:40

    Preliminary Injunctions in generics/brand cases

    Simon Cohen

    Simon Cohen, Partner, Taylor Wessing

  • From Paroxetine to Modafinil- What is the current attitude of the UK Courts?
  • How does the UK regime on preliminary injunctions compare with that of the other main European Patent jurisdictions
  • clock

    12:20

    Networking Lunch

    clock

    13:30

    Pricing pressure's faced by the industry today

    Pieter Dylst

    Pieter Dylst, Financial reporting , Research Centre for Pharmaceutical Care & Pharmaco-economics

  • Examples of tendering systems around the world
  • Implications of tendering for the Generic Medicines industry
  • Generic Medicines is not only a story of prices, it is also about volume
  • Briefly touching upon reference pricing systems
  • clock

    14:20

    Strategies for navigating IP challenges at the interface of the clinic and the patents system

    Paul Brady

    Paul Brady, Patent Attorney, Abel and Imray

  • Minimising barriers to putting your product on the market
  • Keeping competitors away
  • Dealing with conflicting priorities in your organisation 
  • clock

    15:00

    Complex Generics, Chemisimilars and Biosimilars: when is clinical testing adequate?

    John Warren

    John Warren, Director, Medicines Assessment Ltd

  • Quality assurance methodology
  • Dose sensitivity
  • Clinical relevance
  • clock

    15:40

    Chairman’s Closing Remarks and Close of Day Two


    Senior Vice President - EU Business
    Glenmark Generics (Europe)
    Patent Attorney
    Abel and Imray
    Director
    Medicines Assessment Ltd
    Director, Alliance Management
    Merck Serono International S.A.
    Senior Consultant
    MPA Business Services Ltd
    Managing Director
    Pharmawise
    Global Head Generics, Thought Leadership
    IMS Health
    Partner
    Taylor Wessing
    Senior Consultant
    Interpharm Consultancy
    European Patent Attorney
    Head of Branded Generics
    AstraZeneca
    Director
    European Commission
    Financial reporting
    Research Centre for Pharmaceutical Care & Pharmaco-economics
    Managing Director
    BGMA
    General Manager
    ntc pharma
    Director
    Innovate Legal
    Regulatory Affairs Manager
    Diamond PV Services
    Managing Director
    Pharmawise

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    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.

     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

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    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, SAE Media 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@saemediagroup.com

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    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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