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Understanding key legal and regulatory requirements on an international level can be difficult even for the most equipped in-house lawyer or private practitioner. SMi recognises this challenge and is proud to announce its inaugural conference ‘Pharmaceutical Law – A Global Perspective’. Taking a close look at the major jurisdictions, including the US, Europe and Asia, this conference aims to provide you with vital information when launching your product on an international level.

This event will bring together leading lawyers and industry experts to provide key insights and cutting edge information on the latest regulatory, IP, competition and contractual law issues and developments affecting the pharmaceutical industry today. You will learn how international law principles affect patents, data exclusivity and other rights relating to manufacture and sales, how competition law analysis is complicated by intensive state law regulation and how the enlargement of the EU will bring new challenges to overcome.

Hear contributions from experienced practitioners, including:

  • Curt Oltmans, Deputy General Counsel, Novo Nordisk
  • Ewan Livesey, European Vice President, Legal Affairs, IVAX Pharmaceuticals
  • Alexandre Mencik, Senior Legal Counsel, Amgen
  • Francis Marsland, International Legal Director, Biogen Idec
  • Dr Urs Jaisli, Senior Counsel, F. Hoffmann-La Roche
  • Dr Philipp Saame, Senior Counsel, Baxter Healthcare
  • Dr Frank Burkert, European Patent Attorney, Bayer Healthcare
  • Giuliano Chicco, Practice Support Attorney, Johnson & Johnson

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Alexandre Mancik

Alexandre Mancik, Senior Legal Counsel, Amgen

9:10 KEYNOTE ADDRESS

  • An overview of the legal and regulatory issues facing the global pharmaceutical industry today
  • Learn about the international law principles affecting patents, data exclusivity and other rights relating to manufacture and sales
  • Common abuses e.g. pricing practices, refusal to license and restrictions on parallel trade
  • Challenges and limitations in the global market
  • Legal loopholes and potential solutions
  • Previous and current regulatory approvals
  • The Bolar law - the affect of the US provision on the rest of the world
  • James Shehan

    James Shehan, Vice President,General Counsel, Novo Nordisk

    Curt Oltmans

    Curt Oltmans, Deputy General Counsel, Novo Nordisk Pharmaceuticals Inc.

    9:50 THE EUROPEAN EXPERIENCE

    Ewan Livesey

    Ewan Livesey, European Vice President, Legal Affairs, IVAX Pharmaceuticals

  • Key features of the European legislation and updates
  • Defining a medicinal product in Europe
  • Current regulatory issues in Europe
  • Key players in the regulatory process – the European Commission, EMEA, member states – how, when and why do they become involved?
  • Implementation in different European states
  • 10:30 Morning Coffee

    11:00 BIOSIMILAR MEDICINAL PRODUCTS

  • Developing a new biological medicinal product – making the claims
  • Understanding the safety profile of these new medicines
  • Defining the manufacturing process of a biosimilar
  • Analytical methods for biosimilar medicinal products
  • Regulatory framework – following EU policy and legislative developments
  • Scientific and regulatory issues- does it matter if biosimilars differ from the reference product?
  • Explaining the current and future guidelines
  • Alexandre Mancik

    Alexandre Mancik, Senior Legal Counsel, Amgen

    11:40 DRUG SAFETY DEBATE IN THE EU AND THE US

  • Steps by the EMEA: Risk Management Programme
  • Steps by FDA: Drug Safety Board
  • Proposals in US Congress
  • EMEA - FDA co-operation on drug safety
  • Linda Horton

    Linda Horton, Partner, Hogan & Hartson LLP

    Hector Armengod

    Hector Armengod, Associate, Hogan & Hartson LLP

    12:20 Networking Lunch

    13:50 COMPETITION LAW IN THE UK

    Peter Willis

    Peter Willis, Partner, Competition, Regulation & Trade Group, Taylor Wessing (UK)

  • Overview of the UK competition regime
  • Cartels, mergers and abuses of dominance – some recent highlights
  • How do the competition rules interface with pharmaceutical regulation?
  • Impact of the competition rules on pharmaceutical pricing and vice versa
  • Are competition rules applied sympathetically to the economic characteristics of the pharmaceuticals industry?
  • 14:30 EUROPEAN COMPETITION CASES IN THE PHARMACEUTICAL SECTOR

    Paula Riedel

    Paula Riedel, Partner, Linklaters (UK)

  • Rationale for the continuing focus on the pharmaceutical sector
  • Overview of recent abuse of dominance cases
  • Implications of these cases for pricing and other practices
  • Evolution in the Commission’s merger analyses?
  • 15:10 Afternoon Tea

    15:40 ROUND TABLE DEBATES

    Comparing the law and procedure in:

  • Germany
  • USA
  • UK
  • Australia
  • Where to litigate? Benefits/ limitations of litigation in Germany
  • Exploring the litigation process in the USA
  • How to prepare and manage litigation in the UK?
  • Litigation strategies/practices in Australia?
  • Frank  Burkert

    Frank Burkert, European Patent Attorney, Bayer AG

    Simon Cohen

    Simon Cohen, Partner, Taylor Wessing (UK)

    Nigel Stoate

    Nigel Stoate, Partner, Taylor Wessing (UK)

    Duncan Bucknell

    Duncan Bucknell, Senior Associate, Mallesons Stephen Jaques

    Brian Roman

    Brian Roman, Litigation Counsel, Mylan Laboratories, Inc.

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

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Urs Jaisli

    Urs Jaisli, Senior Counsel, F Hoffmann La Roche

    9:10 ENSURING ANTITRUST COMPLIANCE

    Urs Jaisli

    Urs Jaisli, Senior Counsel, F Hoffmann La Roche

  • Devising an antitrust compliance programme
  • Key considerations
  • Identifying and assessing compliance risks
  • Support of top management
  • Company guidelines for behaviour in competition
  • Training of employees
  • Performance of antitrust audits
  • Are compliance investments worth the money?
  • 9:50 TECHNOLOGY AND THE REGULATORY ENVIRONMENT

    Giuliano Chicco

    Giuliano Chicco, Practice Support Attorney, Johnson & Johnson Corporation

  • Training
  • Compliance monitoring
  • Business process support
  • Global considerations
  • Rule-based Tools
  • 10:30 Morning Coffee

    10:50 PATENTS AND THE CHANGING DYNAMICS OF THE (US) GENERIC INDUSTRY

  • 180 day generic marketing exclusivity: forfeitures and triggers
  • Exclusivity forfeitures for failure to market
  • Court decision triggers, including the effect of declaratory judgements
  • Authorised generics during a first-filer’s exclusivity period
  • FDA’s concept of ‘shared’ exclusivity
  • Brian Roman

    Brian Roman, Litigation Counsel, Mylan Laboratories, Inc.

    11:30 A EUROPEAN OUTLOOK ON DATA EXCLUSIVITY

    Bert Oosting

    Bert Oosting, Partner, Lovells (The Netherlands)

  • The status of data exclusivity within intellectual property rights
  • Is data exclusivity necessary?
  • Is there any room for additional periods of exclusivity?
  • Current regulations – how do they affect the rest of the world?
  • Legal uncertainties
  • Patent disputes– some examples
  • Regional differences – extent of diversity?
  • 12:10 Networking Lunch

    13:40 PATENT PRACTICE IN JAPAN

  • An overview of the Japanese patent system
  • Recent statistics of Japanese patent applications
  • Japanese patent practice – making a claim
  • Learn how to prepare and launch litigation in Japan
  • Important features of Japanese patent law and practice as compared with European and US patent practices
  • Guntram Rahn

    Guntram Rahn, Attorney at Law & Partner, Hoffmann Eitle

    15:00 EXPLORING EUROPEAN PARALLEL TRADE

  • Drivers and barriers to parallel trade
  • Enforcing treaties on distribution and supply (Articles 81 and 82)
  • Legal and regulatory changes and implications
  • The scale and value of parallel trade in Europe
  • Legal actions that can be taken against a parallel trader
  • EU Accession – integrating new member states and dealing with price differences
  • Parallel trade and re-packaging – recent case law: Boehringer-Ingelheim vs Swingward (UK)
  • Case law – pending decisions - the Bayer Adalat decision / Syfiat vs GlaxoSmithKline
  • EU harmonisation – a near future possibility?
  • Francis Marsland

    Francis Marsland, International Legal Director, Biogen Idec

    15:40 Afternoon Tea

    16:00 THE EXPLOSIVE GROWTH IN US GOVERNMENT FUNDED PRESCRIPTION DRUG REIMBURSEMENT PROGRAMMES

    Mark Wanda

    Mark Wanda, Vice President, Legal Affairs, Sepracor

  • The $700 billion Medicare prescription drug benefit and proposed Medicaid reforms
  • The enforcement tools that drive pharma company compliance initiatives
  • Current US pharma compliance concerns
  • Drawing the line between permissible exchange of scientific information and impermissible promotion of Prescription drug products for unapproved uses
  • 16:40 ESSENTIAL CONSIDERATIONS FOR AGREEMENTS WITH MAJOR RELEVANCE IN THE PHARMACEUTICAL INDUSTRY

    Philipp Saame

    Philipp Saame, Senior Counsel, Baxter Healthcare

  • Supply and distribution agreements
  • Clinical trial agreements
  • Research and development agreements
  • Practical considerations
  • Product specific clauses (e.g biotech, blood derived products)
  • 17:00 Chairman’s Closing Remarks and Close of Day One

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    Workshops

    Data Exclusivity and Protection
    Workshop

    Data Exclusivity and Protection

    Jurys Great Russell Street Hotel
    4th November 2005
    London, United Kingdom

    Jurys Great Russell Street Hotel

    16-22 Great Russell Street
    London WC1B 3NN
    United Kingdom

    Jurys Great Russell Street Hotel

    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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