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Pharmaceutical Parallel Trade in the European Union is a large and growing phenomenon.


Different regulatory regimes for pharmaceuticals result in significant differences in pharmaceutical prices across countries. These prices make it profitable for Parallel Trade to take place in addition to PT reaching a significant proportion of total national pharmaceutical expenditure in many European countries, particularly those with high pharmaceutical prices such as UK, Germany, the Netherlands and Sweden. But the issue of pharmaceutical Parallel Trade continues to generate controversy among stake holders and has become an issue of intense debate in the global trading system.
 

Europe’s leading Parallel Trade Conference will focus on assessing pricing strategies and the impact of parallel trade on the generics market and vice versa. In addition, there will be three open floor round table discussions drawing attention to the ongoing debate; is parallel trade justified? Stakeholder engagement and competition law effects will be discussed, in addition to a breakfast briefing on assessing data collection… and that’s just to start with.


Patient safety is first and foremost when it comes to the implementation of the Anti-Counterfeit Directive and this will be addressed. What will follow is assessing the repackaging and re-boxing of products. Further topics to be evaluated include case studies on the implementation of best practices and the outcomes to be reviewed on parallel trade, are they positive or negative?
 

The note to end on will be… What’s the future of Parallel Trade?
 

• Hear from those at the heart of Parallel Trade on the core concerns affecting you. Addressing the challenges are Eric Noehrenberg, Janice Haigh and Richard Freudenberg
• Germany are the industry leaders in this field, hear from IGES on Parallel Trade in Germany and what the influencing factors are and analysing the market
• Enhance supply chain protection and patient safety with an update on the Falsified Medicines Directive
• Case study sessions on best practices and implementation, in addition to three round table discussions will generate debate, don’t miss out!
 

   

Directors, Managing Directors, Leaders, Head of:
Research and Development, Market Access, Pricing and Reimbursement, Commercial, Supply Chain Policy, Finance, Anti-Counterfeiting, Business Analysts, Distribution, Legal Affairs


Consultants of Advisors working in Health Economics, Business Development, Supply Chain Security in addition to Pharmacists. 

 

Companies include: 
 

InnoPeritus; Abbott Healthcare products; Allergan Ltd; Amdipharm Mercury Company Limited; Amgen ; Amgen BV; Amgen Europe BV; Amgen Ltd; Amgen Swizerland A G; Arnold and Porter; Astellas Pharma Europe; AstraZeneca; Biogen IDEC International GmbH; Boehringer-Ingelheim; Bristol Meyers Squibb; Chiesi Farmaceutici SpA; Decahedron Ltd.; Delfarma; Domino Uk Limited; Dusseldorf Institute for Competition Economics; Eli Lilly & Co; European Alliance for Access to Safe Medicines; European Commission; European Generic Medicines Association; Genzyme Corporation; Gilead Sciences Europe Ltd; Grünenthal GmbH; GSK; HOLLISTER, INC.; IMS Health; Johnson & Johnson Pharmaceutical; Justpharmareports; Kantar Health GmbH; Kohlpharma GmbH; LEO Pharma; Leo Pharmaceutical Products Ltd. A/S; Merck Sharp and Dohme Israel; MPA Business Services Ltd ; None; Novartis; Novartis (Hellas) SACI; Novartis Pharma AG; Novo Nordisk; Panhellenic Pharmacists Association; Quintiles (UK) Ltd; Shire Pharmaceuticals Group Plc; Teva UK; White & Case LLP;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Eric Noehrenberg

Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

9:10 Overview of Parallel Trade and its impact

Eric Noehrenberg

Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

  • What is parallel trade?
  • Who benefits from parallel trade? Where are negative impacts of parallel trade?
  • Key players in parallel trade and their respective strategies
  • Meeting the challenges of parallel trade
  • 9:50 Parallel distribution - a view from the top

    Heinz Kobelt

    Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

    The European medicines supply chain under stress - and PT taken as its scapegoat

  • Economics in distribution - the legitimate role of wholesaling
  • Ideal profile for a functioning supply chain 
  • In hindsight: what could have worked better in the recent case of medicines stolen in Italy, and ending up via parallel import in Germany?
  • How we see the call from the German MoH to the EU Commission to examine the legal framework for parallel distribution

    10:30 Morning Coffee

    11:00 Assessing pricing strategies for parallel trade

    Janice Haigh

    Janice Haigh, Practice Leader, Market Access, Quintiles (UK) Ltd

  • Price strategy, price competition and equity – defending differential pricing
  • Understanding the role of price strategy in parallel trade management
  • What are the other options?
  • 11:40 KEYNOTE ADDRESS: Initiatives of Parallel Distributors in the context of Falsified Medicines Directive

    Tomasz Dzitko

    Tomasz Dzitko, Founder and CEO , Delfarma

  • Good Parallel Distribution Guidelines                                                                                                                                                                                                                                                                             
  • Early Warning Anti-CF Platform
  • Joint Audits Initiative    
  • European Medicines Verification Organization
  •  

    12:20 Networking Lunch

    13:30 Parallel Trade in Germany – Situation and perspective

    Bertram Häussler

    Bertram Häussler, Chairman of the Board of Management, IGES Institut GmbH

  • Parallel importation dynamics – assessing the impact
  • The evaluation of new drugs in Germany – new paradigm for Parallel Trade?
  • Political and regulatory environment: What`s changed, what is to be expected
  • 14:10 Case Study 1: The role of the pharmacists in parallel trade defined

    Leyla Hannbeck

    Leyla Hannbeck, Head of Pharmacy, The National Pharmaceutical Association Ltd

  • Distribution and supportive programme with the pharmacists as the central person
  • Channels and factors with regulations, market access and other factors
  • Sourcing parallel trade when they’re cheaper and how it’s impacting the pharmacists
  • 14:50 Afternoon Tea

    15:20 EU perspective for Parallel Trade

    • Current trends and drivers of PI
    • Legal framework
    • Developments in EU-memberstates

    Matthias Heck

    Matthias Heck, Attorney-at-law, Head of Brussels office, German Pharmaceutical Industry Association

    16:00 Chairman’s Closing Remarks and Close of Day One

    Eric Noehrenberg

    Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Eric Noehrenberg

    Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

    9:10 EU perspective for Parallel Trade

    Suzanne Elvidge

    Suzanne Elvidge, Specialised writer in healthcare, pharmaceuticals and busines, None

  • Assessing the impact of parallel trade on certain countries
  • Concerns about medicines shortages to lower priced countries
  • Competition law – an overview of what’s likely to happen over the next five years to impact parallel trade
  • 9:50 Supply chain protection and patient safety

    John Jolley

    John Jolley, Director, Pharmaconsult Global Ltd

  • Assessing the security of supply chain to enhance patient safety
  • Evaluating the complexity of European supply chain
  • Reviewing what the hurdles ahead may be
  • 10:30 Morning Coffee

    11:00 Market Outlook and Macro Dynamics

    Shabnam Hanassab

    Shabnam Hanassab, Consultant, IMS Health

  • Developments in last decade
  • Impact on patient and manufacturer
  • 11:40 Effects of parallel trade on affordable access to medicines in the EU

    Dermot Glynn

    Dermot Glynn, Senior Advisor, Europe Economics

  • Effects on prices
  • Effects on timing of launch
  • Effects on reliability of supply
  • Effects on innovation
  •  

    12:20 Networking Lunch

    13:30 KEYNOTE ADDRESS - Intellectual Property Update

    Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter

  • Can brand names be changed in parallel trade? Recent case law
  • Specific Mechanism - the Advocate General’s Opinion?
  • Other recent developments
  • Practical implications
  • 14:10 Patient Safety – Fighting the Fakes

    Mike Isles

    Mike Isles, Executive Director, European Alliance for Access to Safe Medicines

  •  The evolving internet rogue pharmacy environment
  • Law enforcement and collaborative voluntary actions 
  •  Addressing the issue of online demand by patients  
  • 14:50 Afternoon Tea

    15:20 Government intervention in exporting countries, a new trend?

    Antonio Mendonca Alves

    Antonio Mendonca Alves, CEO, MD Pharma SA

  •  Examples of government intervention is exporting countries
  • Are governments trying to restrict exports? Is this legitimate?
  • Are there alternatives?
  • 16:00 ROUND TABLE DISCUSSION - A clear divide still stands - The Big Debate!

    Antonio Mendonca Alves

    Antonio Mendonca Alves, CEO, MD Pharma SA

  • Ethics of Parallel Trade and the Originators
  • Input and perspective on what the ethics of parallel trade and the originators are
  • Greece as a target – is ring fencing in place or will it be?
  • Is parallel trade justified – different perspectives  
     
  • 16:40 Chairman’s Closing Remarks and Close of Day Two

    Eric Noehrenberg

    Eric Noehrenberg , Director, Regional Market Access lead, Shire GmbH

    +

    FEATURED SPEAKERS

    Antonio Mendonca Alves

    Antonio Mendonca Alves

    CEO, MD Pharma SA
    Bertram Häussler

    Bertram Häussler

    Chairman of the Board of Management, IGES Institut GmbH
    Christopher Stothers

    Christopher Stothers

    Partner, Arnold and Porter
    Dermot Glynn

    Dermot Glynn

    Senior Advisor, Europe Economics
    Eric Noehrenberg

    Eric Noehrenberg

    Director, Regional Market Access lead, Shire GmbH
    Janice Haigh

    Janice Haigh

    Practice Leader, Market Access, Quintiles (UK) Ltd
    Matthias Heck

    Matthias Heck

    Attorney-at-law, Head of Brussels office, German Pharmaceutical Industry Association

    Antonio Mendonca Alves

    CEO, MD Pharma SA
    Antonio Mendonca Alves

    Bertram Häussler

    Chairman of the Board of Management, IGES Institut GmbH
    Bertram Häussler

    Christopher Stothers

    Partner, Arnold and Porter
    Christopher Stothers

    Dermot Glynn

    Senior Advisor, Europe Economics
    Dermot Glynn

    Eric Noehrenberg

    Director, Regional Market Access lead, Shire GmbH
    Eric Noehrenberg

    Heinz Kobelt

    Director European Affairs, European Association of Euro-Pharmaceutical Companies
    Heinz Kobelt

    Janice Haigh

    Practice Leader, Market Access, Quintiles (UK) Ltd
    Janice Haigh

    John Jolley

    Director, Pharmaconsult Global Ltd
    John Jolley

    Leyla Hannbeck

    Head of Pharmacy, The National Pharmaceutical Association Ltd
    Leyla Hannbeck

    Matthias Heck

    Attorney-at-law, Head of Brussels office, German Pharmaceutical Industry Association
    Matthias Heck

    Mike Isles

    Executive Director, European Alliance for Access to Safe Medicines
    Mike Isles

    Shabnam Hanassab

    Consultant, IMS Health
    Shabnam Hanassab

    Suzanne Elvidge

    Specialised writer in healthcare, pharmaceuticals and busines, None
    Suzanne Elvidge

    Tomasz Dzitko

    Founder and CEO , Delfarma
    Tomasz Dzitko

    Sponsors and Exhibitors

    Supporters

    Workshops

    Parallel Trade - Management Strategies
    Workshop

    Parallel Trade - Management Strategies

    Holiday Inn Regents Park
    11th February 2015
    London, United Kingdom

    Parallel Trade for Accession States
    Workshop

    Parallel Trade for Accession States

    Holiday Inn Regents Park
    11th February 2015
    London, United Kingdom

    Parallel Trade Event Attendees 2015

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    PMR (www.pmrcorporate.com) is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern European countries as well as other emerging markets. PMR's key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research ). Being present on the market since 1995, offering high international standards in projects and publications, as well as providing one of the most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.


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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.

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    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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