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Conference Documentation: Pharmaceutical Law - A Global Perspective

DateNov, 2005
Pages0
Price / format$998 / Hard Copy Mail Delivery
$2994 / CD-Rom Delivery - Site License
$1398 / CD-Rom Delivery with Audio - Single User
$4194 / CD-Rom Delivery with Audio - Site License
$998 / CD-ROM Mail Delivery

$998 

Report Information | Custom-Tailored Research | Product Trade Lead


Abstract:
 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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