Conference Day One: 21st October 2008

08.45 Pharma IQ Welcome

08.50 Chairperson’s Opening Remarks

09.00 Taking Lessons From The MHRA Anti-Counterfeiting Strategy And Recent UK Incidences To Improve Your Security Programme

The Medicines and Healthcare products Regulatory Agency (MHRA) is implementing strategic and operational measures designed to minimise the risk of counterfeit medicines and medical devices reaching patients through both the regulated and unregulated supply chains.

This presentation will examine the following:

• Counterfeit medicine assessment for the UK
• Communication of the threat
• Collaboration with stakeholders
• Proportionate regulation to minimise the risk
• MHRA Enforcement activity
• Internet supply initiatives

Michael Deats
Group Manager, Enforcement and Intelligence Medicines and Healthcare products Regulatory Agency
MHRA

09.45 Working Together For A Harmonised Coding And Identification Solution Of Pharmaceutical Products Across Europe: How The EFPIA Initiative Can Improve Patient Safety And Product Security Through Co-Operation With Stakeholders

EFPIA fully supports the new commitment taken by the EFPIA fully supports the new commitment taken by the international community to step up the fight against counterfeit medicines with the primary objective of protecting patient health.

This presentation will explain the drivers for this concept and discuss how it can best be implemented by the industry and key stakeholders, including:

• Traceability improvements that are needed today
• Reasons to implement a unique coding solution
• The EFPIA proposal for the coding and identification of pharmaceuticals
• The impacts and key benefits for the main stakeholders
• Considering the prerequisites needed, in order to obtain stakeholders support and deploy the concept efficiently

Jean-Marc Bobée
Chairman of the EFPIA project for coding and identification of pharmaceuticals in Europe, EFPIA, Industrial affairs, Strategy and Technologies
Sanofi Aventis

11.00 A Practical Review Of Legal And Administrative Weapons In The EU Fight Against Physical And Online Counterfeits

This presentation will consider the administrative, civil and criminal remedies available in the EU to brand owners in the fight against global counterfeiting activities occurring in both the physical and online market place. They will apply these remedies to a hypothetical case study.

Ray Black
Partner
SJ Berwin

Paul Cox
Senior Associate, Intellectual Property
SJ Berwin

11.45 Counterfeit Pharmaceuticals: How To Combat The Threat Of The Internet

• Internet pharmacies: convenient, but deadly
• The risks and the reality: hear real case studies
• Possible safeguards to protect patient safety
• The challenge for stakeholders

Andrew Jackson
Deputy Global Head, Corporate Security
Novartis

12.30 Creating A Business Model For An Action Plan To Counter Counterfeiting

• Bias for action is critical: There are good and easy-to-implement things that can be done now, while more advanced technologies are reaching maturity
• Using a phased implementation plan gets you started with a basic approach, allowing you to add security features over time
• A layered approach provides practical methods of authentication at each link of the distribution chain, including the customers’ medicine cabinet
• Communicating is critical: let your customers and the counterfeiters know you are taking countermeasures
• Align with other industry participants to raise public awareness, drive policy, and share resources

Steven J. Powell
General Manager, Security Solutions, Graphic Communications Group
Eastman Kodak Company

14.20 Peaks And Troughs For Parallel Trade In The Enlarged EU

The complexities of the European distribution system create numerous opportunities for counterfeit medicines to enter the legitimate supply chain. Indeed, this has happened, with tens of thousands of packs of counterfeit medicines reaching patients. Against this background, a new and potentially serious development is about to happen. Since their accession to the EU, countries from Central and Eastern Europe have been prohibited from the so-called "parallel trade." In essence, because of previous patent protection in the "old" Europe, these countries have been subject to a form of derogation. As this derogation comes to an end, CEE countries will be free to take part in the free trade of medicines and medicinal products.

This presentation examines:

• The opportunities and risks from the patient safety perspective
• The readiness or otherwise of CEE regulatory systems
• The growth of counterfeit medicines in Europe
• How stakeholders might co-operate to prepare for the end of derogation

Jim Thomson
CEO
The European Alliance for Access to Safe Medicines (EAASM)

15.00 Panel Discussion: How CEE Regulators Are Preparing For The End Of Derogation

Panelists:

Jim Thomson
CEO
The European Alliance for Access to Safe Medicines

Anna Wachnik-Swiecicka
Head of Section for Product Information Evaluation
Office for registration of medicinal products, medical devices and biocides, Poland

Representative from the Bulgarian Drug Agency

15.45 Parallel Distribution And A Safe Supply Chain: How The Two Can Exist Successfully Together

While legal in the EU/EEA area, parallel trade is often perceived by manufacturers (although not by regulators) as a weakening of the distribution chain. The EAEPC argues that its members provide identical medicines at lower cost than manufacturers' prices to patients and final payers. Members share with manufacturers the objective of fighting against counterfeits and raising the barriers to keep these out of the legitimate supply chain.

This presentation considers:

• The regulatory environment for parallel distribution
• The rigorously controlled business practices of repacking and re-labelling
• Cases where the safety profile of the industry is demonstrated
• Ways to improve the supply chain, in the light of the
• UK counterfeit case in 2007: without jeopardising the free movement of pharmaceuticals across Europe

Heinz Kobelt
Secretary General
European Association Euro-Pharmaceutical Companies

16.20 Developing Product Brand Integrity

• The challenges Baxter BioScience experienced with counterfeited products
• How to analyse the root of the problem
• The programme undertaken to ensure product brand integrity
• Expectations for the future

Philippe Majois
Divisional Packaging Technology Development
Baxter BioScience

16.50 Security And Business Value With The Same Investment (or Same Infrastructure)

• Overview of regulatory and business challenges for secure supply chain for pharma mfrs
• additional business challenges facing pharma mfrs - inventory mgmt, returns/recalls, sample tracking, etc.
• Scalable, global IT infrastructure to address both challenges
• Overview of how data sharing can enable the business applications
• Potential benefits
• How to get started

Paul Chang
WW Strategy and Market Development
IBM SWG

17.20 Panel Discussion: Combining Authentication And Tracking Of Healthcare Products

The panel will focus on some of the coming challenges of serialisation and authentication in the pharmaceutical industry.The approaches to these problems are many and often confusing, and the panel will discuss which are cost effective and what the common pitfalls are. We will also discuss how the twin aims of authentication and “track and trace” can be best accommodated in a coherent and coordinated product security strategy. Finally,we will aim to give a flavour of some of the government and regulatory activities ongoing in this field round the world.

Discussion Leader:

Mark Davison
VP Global Pharmaceuticals
SICPA

Panel Speakers:

Philippe Majois, Divisional Packaging Technology Development, Baxter BioScience

Jean-Marc Bobée
Chairman of the EFPIA project for coding and identification of pharmaceuticals in Europe, EFPIA, Industrial affairs, Strategy and Technologies
Sanofi Aventis

Tracy Hassan
Director of Global Brand protection
Johnson & Johnson Health Care Systems Inc.

18.00 Closing Remarks From Chairperson And End Of Day One

18.30 Drinks Networking Reception

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