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Join SMi 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, SMi’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.

This seasoned event has provided delegates year on year the perfect opportunity to discuss and develop ideas with industry leaders and provide a platform for developing new strategies moving forward. Testimonials from our highly successful event in 2012:


"Getting better every year”Harvest Moon Pharmacueticals
"Overall, great meeting with expert speakers” Sandoz
“Outstanding “- IMS health

 

Overcome the challenges of API synthesis and conforming to new EU Bioequivalence guidelines
Address the latest changes in regulatory affairs in key global markets
Navigate around, and challenging IP’s with a topic focussed on the outcome of AstraZeneca’s filing for a breach of patent surrounding their   gastro-protective compound Omeprazole.
Consider the Impact of Asian markets on the European generics industry.
Evaluate and develop strategies around Ever-greening practices employed by innovator companies to stave off Generic Competition.

Business Development Directors

Brand Manager

Chief Medical Officer

Clinical Regulatory Strategy Manager

Commercial Director

Head Global Licensing

Head of Pharmacology

Medical Affairs Director

 Principal Scientist

VP Chemistry

VP, Research

Legal Council

Associate Clinicians

Chief Executive Officer

Chief Scientific Officer

Clinical Pharmacologist

Director of Medical Affairs

Head of Clinical Science

Managing Director

Medical Director

Vice President

VP, Clinical

Head of Regulatory affairs

Consultants

Bt 30; Daher CIS; E D P Valor S A; Great Lakes Regional Office; INDIAN HERBS RESEARCH & SUPPLY CO LTD; INDIAN HERBS SPECIALITIES; IXL Pharma Ltd; Mississippi TSA Aviation Operations; Petromax/former Moscomet LLC; R M Vredenburg & Co; SIMPEX PHARMA PVT LTD; SMITH & KENNER PHARMACEUTICALS (P) LTD; Subcommittee on Surface Transportation and Merchant Marine Infrastructure, Safety and Security; University Of Illinois; Vodafone Limited; Warrington Borough Council;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Bernd Stoiber

Bernd Stoiber, Head of Branded Generics, AstraZeneca

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
  • 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
  • 10:30 Morning Coffee

    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 
  • 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

     

  • 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

    13:00 Networking Lunch

    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?
  • 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
  • 15:20 Afternoon Tea

    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
  • 16:20 SPC's and all that

    Martin Paltnoi

    Martin Paltnoi, Senior Consultant, MPA Business Services Ltd

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Rahul Garella

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

    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
  • 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
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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
  • 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 
  • 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
  • 15:40 Chairman’s Closing Remarks and Close of Day Two

    +

    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

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

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    Kensington
    London W8 5SR
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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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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, United Kingdom, Link to Map
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