Product Type: Market Research Report
Published by: SMI Publishing, Ltd
Published: November 2005
Product Code: R215-386Description 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
Table of Contents - Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mr Alexandre Mancik, Senior Legal Counsel, Amgen .
- 9.10 KEYNOTE ADDRESS
- Understanding key pharmaceutical law / regulatory issues in the major jurisdictions - North America, Europe and Asia
- 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
- Mr James Shehan, Vice President, General Counsel, Novo Nordisk Pharmaceuticals Inc..
- Mr Curt Oltmans, Deputy General Counsel, Novo Nordisk Pharmaceuticals Inc..
- 9.50 THE EUROPEAN EXPERIENCE
- Understanding the new pharmaceutical legislation for Europe
- 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
- Mr Ewan Livesey, Vice President, Legal Affairs, European Region, IVAX Pharmaceuticals.
- 10.30 Morning Coffee
- 11.00 BIOSIMILAR MEDICINAL PRODUCTS
- Particular attention for special 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
- Mr Alexandre Mancik, Senior Legal Counsel, Amgen .
- 11.40 DRUG SAFETY DEBATE IN THE EU AND THE US
- What next after Chiron, SSRIs and Vioxx?
- Steps by the EMEA: Risk Management Programme
- Steps by FDA: Drug Safety Board
- Proposals in US Congress
- EMEA - FDA co-operation on drug safety
- Ms Linda Horton, Partner, Hogan & Hartson LLP.
- Mr Hector Armengod, , Hogan & Hartson LLP.
- 12.20 Networking Lunch
- 1.50 COMPETITION LAW IN THE UK
- Current and future issues
- 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?
- Mr Peter Willis, Partner, Competition, Regulation & Trade Group, Taylor Wessing (Solicitors).
- 2.30 EUROPEAN COMPETITION CASES IN THE PHARMACEUTICAL SECTOR
- A review of recent developments
- 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?
- Ms Paula Riedel, Partner, Linklaters.
- 3.10 Afternoon Tea
- 3.40 ROUND TABLE DEBATES
- PATENT LITIGATION IN MAJOR JURISDICTIONS
- 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?
- Mr Simon Cohen, Partner, Taylor Wessing (Solicitors).
- Mr Nigel Stoate, Partner, Taylor Wessing (Solicitors).
- Mr Duncan Bucknell, , Mallesons Stephen Jaques.
- Dr Frank Burkert, European Patent Attorney, Bayer Healthcare.
- Mr Brian Roman, Litigation Counsel, Mylan Laboratories.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Urs Jaisli, Senior Counsel, F Hoffmann La Roche .
- 9.10 ENSURING ANTITRUST COMPLIANCE
- Case study: 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?
- Dr Urs Jaisli, Senior Counsel, F Hoffmann La Roche .
- 9.50 TECHNOLOGY AND THE REGULATORY ENVIRONMENT
- Meeting regulatory requirements through the creative use of technology
- Training
- Compliance monitoring
- Business process support
- Global considerations
- Rule-based Tools
- Mr Giuliano Chicco, Practice Support Attorney, Johnson And Johnson.
- 10.30 Morning Coffee
- 10.50 PATENTS AND THE CHANGING DYNAMICS OF THE (US) GENERIC INDUSTRY
- Current challenges for generic companies
- 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
- Mr Brian Roman, Litigation Counsel, Mylan Laboratories.
- 11.30 A EUROPEAN OUTLOOK ON DATA EXCLUSIVITY
- How to legitimately protect your patent
- 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?
- Mr Bert Oosting, Partner, Lovells.
- 12.10 Networking Lunch
- 1.40 PATENT PRACTICE IN JAPAN
- Characterising Japanese patent law
- 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
- Dr Guntram Rahn, Attorney at Law & Partner, Hoffmann Eitle.
- 3.00 EXPLORING EUROPEAN PARALLEL TRADE
- An overview of the rules relating to the distribution and import (in parallel) of medicines
- 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?
- Mr Francis Marsland, International Legal Director, Biogen Idec.
- 3.40 Afternoon Tea
- 4.00 THE EXPLOSIVE GROWTH IN US GOVERNMENT FUNDED PRESCRIPTION DRUG REIMBURSEMENT PROGRAMMES
- Their impact on pharmaceutical company compliance programmes
- 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
- Mr Mark Wanda, Vice President, Legal Affairs, Sepracor Inc.
- 4.40 ESSENTIAL CONSIDERATIONS FOR AGREEMENTS WITH MAJOR RELEVANCE IN THE PHARMACEUTICAL INDUSTRY
- Conclusions from recent legislative developments
- Supply and distribution agreements
- Clinical trial agreements
- Research and development agreements
- Practical considerations
- Product specific clauses (e.g biotech, blood derived products)
- Dr Philipp Saame, Senior Counsel, Baxter Healthcare.
- 5.00 Chairman’s Closing Remarks and Close of Day One
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