The Programme

Day One: Tuesday 1 July 2008

Registration

Opening remarks from the Chair

Big pharma, generics and parallel trade: fighting counterfeits together?

• Overcoming competitive tension
• Tighter regulation versus free trade
• The standpoint of one major multinational

Corporate strategies for an effective response to counterfeit pharmaceuticals

• What makes counterfeiting possible?
• Who are the stakeholders?
• Why it’s important to coordinate internal resources first
• Ideas for setting strategic goals
• Primary objectives of a corporate anticounterfeit programme

Morning refreshments

The real cost of counterfeiting and diversion to the pharmaceutical industry

• An overview of the global trade in counterfeit pharmaceuticals
• The real cost to the brand: combating
• damage to a manufacturer’s reputation
• Examining the safety risks associated with counterfeit products
• The ultimate price: the direct cost to the consumer

Anti-counterfeiting: the need for collective action

• The potential health risks for citizens and the lack of concrete and coordinated action
• Assessing the technological building blocks available and the lack of consensus for any particular solution
• The search for feasible solutions and regulatory clarity
• Introducing the ITAIDE (EU IST FP 6 Integrated Project)
• Drug Living Lab and its attempts to facilitate coordinated action by linking a pilot project and community building

Lunch

The contribution of parallel distribution to a safe supply chain

• Maintaining the perception of parallel distribution as the third legitimate and safe market player in the EU since 1970’s
• Providing an additional layer of safety in the
• pharmaceutical supply chain in fighting counterfeits and raising barriers to keep supply chains secure
• Examples of new initiatives and measures to improve the safety and security of the supply chain without jeopardising the freedom of movement of pharmaceuticals across the EU/EEA

Innovative solutions for pharma counterfeit prevention

• Current global pharma counterfeiting challenges
• Existing solutions
• Innovative solutions / Bilcare research

Smart packaging for brand protection

• Smart packaging as a tool to overcome issues in supply chain such as breakages and pilferage
• Use of innovative packaging and security features to overcome threats from counterfeits
• Examining the cost implications and potential ROI
• Understanding the effect on the supply chain

Afternoon refreshments

Closing the security loop: extending e-pedigree from package to patient

• The escalation of counterfeit medicines: estimated to reach $75 billion by 2010
• The deficiencies of common brand protection and e-pedigree solutions: focus on On-Package solutions
• The benefits of On-Dosage technologies that complement On-Package solutions to extend protection to the patient
• Combined with a pro-active product sampling program at the retail level, On-Dosage technologies can provide an
• Providing an "early warning" system for counterfeits: using On-Dosage technologies combined with a pro-active product sampling programme at the retail level to strike back at counterfeiters

Europol's contribution in the fight against counterfeit medicines

• Europol’s structure and framework
• The scope and magnitude of Intellectual Property crime
• Proposals and actions to support Europol partners

What industry can do to secure and protect the supply chain: barcoding

• Patient safety and counterfeit medicines
• Mass serialisation and product authentication
• Supply chain security and track and trace
• Product recall
• One solution!

Closing remarks from the Chair and close of Day One

Day Two: Wednesday 2 July 2008

Registration

Opening remarks from the Chair

Hampering counterfeited medicines entering the market: an integrated approach

• The counterfeit, diversion and illegal trade environment
• Internal organisation to adequately respond to requests
• • What is the purpose of a reorganisation?
  • Cooperating with other parties involved
• law enforcement, health authorities, other pharmaceutical companies among others
• Pros and cons of adding safety features to packs
• Securing the supply chain

Our approach to creating a secure chain

• An overview of our products and supply chain structure
• Challenges and potential threats to our product
• The tools and technologies we use to combat counterfeiting, diversion and protect our product

Morning refreshments

Krypsos: a single point of contact for the supply chain to manage anti-counterfeiting and to uncover grey markets.

• Covert security marking and overt identification: two distinct features and goals
• Regular visible ink used for invisible (covert) marking for a genuine or fake authentication
• Implementation of a worldwide anti-counterfeiting program and grey market uncover
• ·Anti-counterfeiting open platform for the entire supply chain including end-consumers.

The internet threat: a new supply chain model for counterfeit pharmaceuticals

• Why the internet is the perfect route to market for counterfeit drugs
• Diminishing the threat
• Results of a study into the sale of counterfeit pharmaceuticals online
• What can be done in terms of a mitigation strategy

Lunch

Applying a risk management approach throughout the supply chain

• Current industry and regulatory trends in pharmaceutical manufacture and distribution
• Risk management – strategic or tactical?
• Developing a risk management process
• Balancing risk versus cost

PANEL DISCUSSION: Choosing the best approach to security

• Examining the variety of options available
• Deciding on the technologies to use at a product, packaging, pallet and case level
• Ensuring that the various aspects of the chain are compatible

Afternoon refreshments

BRIDGE Pharma Traceability Pilot – mass serialisation in the European supply chain: early results

• About the BRIDGE Project
• Mass serialisation and data aggregation
• User implementation
• Pilot operation
• Experiences and lessons learned

Global standards to enable effective and efficient traceability in healthcare

• The need for global standards
• Building blocks: identification keys and data carriers (bar codes or RFID)
• Towards a Global Traceability Standard

Closing remarks from the Chair and end of conference