“Best annual review of topical pharma law
The 17th Annual subject matters”
(EU Pharmaceutical Law Forum 2007, Manager, Sanofi-Aventis)
EU Pharmaceutical
Law Forum Bar Council 13.5 CPD hours
SRA 13.5 CPD hours
A complete round up of the years most high profile cases and examination of
future trends and challenges
8-9 May 2008, The Renaissance Hotel, Brussels, Belgium
www.informa-ls.com/pharmalaw
Conference highlights: Bringing together top level legal know-how:
● Article 81: Licensing, distribution arrangements, ❚ Marleen Van Kerkhove, Arnold and Porter
settlement agreements ❚ Stephen Kon, SJ Berwin LLP, London and
Brussels
● Article 82: The Astra/Zeneca case and its
consequences for the pharmaceutical industry, plus ❚ Cameron Firth, SJ Berwin LLP, London and
lessons to be learned from Microsoft Brussels
❚ Gavin Robert, Linklaters
● Restructuring distribution systems in europe
❚ David Marks, Cameron McKenna
● Analysis of patent actions in Europe ❚ Nick Beckett, Cameron McKenna
● European Legislation Initiatives- EPC 2000, EPLA ❚ Linda Horton, Hogan and Hartson
and The Enforcement Directive ❚ Marjan Noor, Howreys
● Implementation of the New Medicines Legislation ❚ Prof. Willem Hoyng, Howreys
and adoption of the New Penalties Regulation ❚ Maria Manley, Bristows
● Update on the state of play with Biosimilars ❚ Peter Bogaert, Covington & Burling
❚ Tanguy Van Overstraeten, Linklaters
● The European Clinical Trials Directive
❚ Victoria Kitcatt, Pfizer
● Practical experience of working with the new EU ❚ Dr Adela Williams, Arnold and Porter
Paediatric Medicines Regulation
❚ Alison Dennis, Reed Smith
● Marketing and promotion- Ensuring compliance with
ABPI code of practice
NEW For 2008
Evening Symposium and Networking Dinner
NEW TOPICS for 2008 include:
● Anti-Counterfeiting- Regulatory and legal solutions EU Medical Device Directive Update &
Regulation of Drug-Device Combination
● The Regulatory framework for Biobanking Products
● State of play with the adoption of Advanced Media Partners
Therapies Legislation
● Economic justifications: Case study-NICE
Judicial Review
To Register Please Tel: +44 (0) 20 7017 7481
Fax: +44 (0) 20 7017 7823
Book online: www.informa-ls.com/pharmalaw
Email registrations@informa-ls.com
EU Pharmaceutical law Forum bringin
competent judges
Day One: 8 May • The Enforcement Directive: ex parte injunctions, saisie,
discovery or nothing? transborder evidence; full costs
Prof. Willem Hoyng, Managing Partner Europe, Howreys,
08.00 Coffee and Registration President EPLAW
08.50 Chairmans introduction 15.40 Questions and Discussion
09.00 Lifecycle Management and Settlement Agreements 15.50 Afternoon Tea
• When do they risk infringing EC competition rules?
• An analysis under Article 81 and 82 EC Treaty 16.20 Anti-Counterfeiting- Regulatory and Legal Solutions
• A comparison with US precedent • What companies can do to protect against counterfeit
Marleen Van Kerkhove, Partner, Arnold and Porter products - control systems, limit wholesales, attempt more
product specific marking
10.05 The Astra/Zeneca Case and Its Consequences for the • Legal procedures to try and stop movement of counterfeit
Pharmaceutical Industry goods e.g., customs seizure
• Significance of the Astra/Zeneca case • EU and national measures
• The appeal: state of play • International cooperation (WHO IMPACT and Council of
• The impact of the Astra/Zeneca case on data protection and Europe)
generic pharma licensing Linda Horton, Hogan and Hartson
• Likely new Commission initiatives
Stephen Kon, Partner, SJ Berwin LLP, London and 16.55 Panel Session: The Regulatory Competition Law/IP
Brussels Interface
Cameron Firth, Senior Associate, SJ Berwin LLP, London
and Brussels 17.30 End of Day One and Networking Drinks
10.40 Article 82: Lessons to be learned from Microsoft EVENING SEMINAR
• A review of the key elements of the Microsoft judgment
• Impact on the pharmaceuticals industry 18.30 Registration 18.45 Start 21.00 Dinner
• Requests for compulsory licensing of IPRs With more pharmaceutical companies working with medical devices and
Gavin Robert, Partner, Linklaters drug device combination products this evening symposium is a time
efficient way for legal professionals to keep up-to-date with changes in
11.15 Questions and Discussion the regulatory guidelines in this area.
11.30 Morning Coffee EC Medical Device Directives Update
• EC Medical Devices Regulation - Gaps and issues
12.00 Changes in the Supply Chain • Recent amendments and developments
• Using fewer wholesalers • Where are we now?
• Direct selling models Grant Castle, Partner, Covington & Burling LLP
• Exclusive distribution/homecare
• Office of Fair Trading report on distribution of medicines Regulation of Drug-Device Combination Products
David Marks, Partner, CMS Cameron McKenna LLP • Interpreting current guidelines
• Initiatives underway for combination products
12.35 Parallel Trade, Preparing Products for Market: What Lincoln Tsang, Partner, Arnold & Porter LLP
Can Companies Do
• The commercial perspective
• The legal framework (including a review of recent case law)
• Branding strategies Day Two: 9 May
• Stock management strategies
• Regulatory strategies
Nick Beckett, Partner, CMS Cameron McKenna LLP 09.00 Chairmans Introduction
13.10 Lunch 09.10 Update on the Latest Issues Arising out of the "New"
Pharmaceutical Legislation and Highlights on the New
14.30 Analysis of Patent Actions in Europe Penalties Regulation
• Overview of procedure in key jurisdictions • Key issues for the pharmaceutical industry (data exclusivity,
• Recent developments on procedural steps in patent actions global marketing authorisation concept, implementation of the
• Pan-European comparison of recent decisions on validity and decentralised procedure v. mutual recognition procedure, the
infringement patent carve-out provision).
• Tactical decisions on choice of jurisdiction • Discussing and analysing any relevant case law.
Marjan Noor, Partner, Howreys LLP • EU Bolar-type provision: what are the implications of a lack of
harmonisation on the implementation of the Pharma
15.05 European Legislation Initiatives legislation?
• EPC 2000: Conflicting national rights; Central limitation, a • Overview of the Penalties Regulation: highlighting the issues
dream for the litigator? Do we have a doctrine of equivalents for pharmaceutical companies and how the Regulation will
in Europe? work in practice
• EPLA/ Community patent Maria Isabel Manley, Partner, Bristows
- Where are we?
- Portuguese / Slovenian progress 09.45 Update On The State of Play with Biosimilars
- moving to CEPLA • Overview of existing legal situation and guidelines
- invalidity in Thessaloniki; languages; keep the ECJ out please; • Approvals to date and recent decisions
To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823
Book online: www.informa-ls.com/pharmalaw Email registrations@informa-ls.com
ng together top level legal know-how
• Focus on 2nd generation issues, including INN naming and • Analysis of recent cases heard by the PMCPA and by the
substitution MHRA: What companies should be doing to avoid sanctions
• Legal remedies • The Internet: be web aware
Peter Bogaert, Covington & Burling LLP • Discussions on information to patients- creating a more
flexible framework to get more factual information to patient
10.20 Morning Coffee Alison Dennis, Partner, Reed Smith
10.50 Understanding The Evolving Regulatory Framework for 16.10 Chairmans Closing Remarks
Biobanking
• Current regulations for storage and handling of tissues for 16.15 End of Conference
research purposes
• Outline of DG Sanco directive and the way implemented in
national laws Commercial Opportunities:
• Data protection rules- tissues and associated data are Call for Sponsors and Exhibitors
personal data
• Data privacy issues applied to biobanking- data privacy, ethical Informa Life Sciences 17th Annual EU Pharmaceutical Law Forum
rights to compensation is the perfect platform for organisations looking to raise their
• Exploring differences between EU and USA corporate profile.
To be announced. Please visit www.informa-ls.com/pharmalaw
for further information
3 Key Reasons to Become an Event Partner:
11.25 Overview and State of Play concerning the Advanced
Therapies Regulation 1. Position your company before a global audience. Last
• What is an advanced therapy, definition and classification year’s event was attended by over 150 senior level professionals from 23
• What is the legislation, how does it work, what does it mean countries (Austria, Belgium, Czech Republic, Denmark, Finland, France,
to go through the regulation, When is it set to be Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland,
implemented, what will be the effects Portugal, Romania, Russia, Spain, Sweden, Switzerland, Turkey, UK, USA).
• What impact will the Regulation have on existing classification
of medical devices? 2. Access senior level professionals. Those who attended
• What problems will the new rules potentially cause include Advocaat, Associate, Attorney, Chief Legal Counsel, Chief Legal
companies, practical implications Officer, Corporate Counsel, Corporate Regulatory Affairs Manager, Director
Elisabethann Wright, Counsel, Hogan and Hartson
& Senior Counsel, Director of Legal Affairs, European Patent Attorney,
12.00 Lunch Head of Legal Affairs, Managing Partner, Partner, & VP from General
Counsel in pharmaceutical companies in addition to lawyers in private
13.20 The European Clinical Trials Directive: Recent practice advising the pharmaceutical sector.
Developments
• New regulatory and industry initiatives 3. Association with Europe’s leading Pharmaceutical Law
• Classification issues (interventional vs non-interventional, Conference.
experimental studies) EU Pharmaceutical Law Forum 2007 Testimonials
• Investigators' compensation
• Health personal data (privacy) issues “Excellent forum to interact with clients and fellow
• Online trials professionals and very expert content”
Tanguy Van Overstraeten, Partner, Linklaters (A&L Goodbody Solicitors)
13.55 Practical Experience of Working with the New EU “Very useful update on key issues affecting the industry”
Paediatric Medicines Regulation (Bristol-Myers Squibb)
• Company experiences with submission, validation and
assessment of Paediatric Investigation Plans
“A very succinct and practical analysis of the hot topics
• Outstanding legal and practical issues in relation to
facing the pharma industry this year”
Supplementary Protection Certificates, rewards and obligations
under the Paediatric Medicines Regulation (Shire Pharmaceuticals)
• New and future developments
Victoria Kitcatt, Assistant General Counsel, European For more information on how your organisation could benefit from this
Regulatory Law, Pfizer European Pharmaceutical event and to discuss the full range of lead generating, networking and
Operations branding opportunities please contact:
14.30 Afternoon Tea Linda Cole Tel: +44(0) 20 7017 6631 Email:
Linda.cole@informa.com
15.00 Economic Justifications: Case Study-NICE Judicial
Review
• Legal challenges to decisions by NICE and similar bodies
PTI is a global pharmaceutical training company with
• Strategic considerations for the appraisal process and over 60 interactive courses focusing on Regulatory
• Outcomes of the judicial review and future implications Affairs, R&D, Clinical Development and Manufacturing
Dr Adela Williams, Partner, Arnold and Porter best practices. Whether you are new to the industry, or
firmly established and looking for training to take you
15.35 Marketing and Promotion: Ensuring Compliance with to the next level, you will receive practical information and comprehensive advice to
meet the demands of a challenging career in pharmaceuticals.
ABPI Code of Practice and the MHRA Blue Guide
Our courses can also be delivered on-site, specifically tailored to place emphasis on your
• Update on the ABPI code of conduct company's own particular business objectives.
• Interaction with the EFPIA code and its recently updated
For more information on PTI, please contact: Simon Lau
version Tel: +44 (0) 20 7017 7165 e-mail: slau@pti-courses.com
• Recently published PMCPA advice
To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823
Book online: www.informa-ls.com/pharmalaw Email registrations@informa-ls.com
EU Pharmaceutical Law Forum
8-9 May 2008, The Renaissance Hotel, Brussels, Belgium
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