09.00 Pharma IQ’s And Chair’s Welcome

09.15 Is Counterfeiting Really A Problem And How Can We Deal With It?

The identification of these issues by David Shore, Pfizer, will ensure that the scene is set to assess which problems are really causing the most impact on Pharmaceutical companies in combating counterfeit goods. David will then discuss the potential solutions for the problems, providing successful best practice tips for you and your company to implement. David’s talk will discuss:

• What is a counterfeit medicine?
• Why is it a problem?
• Who is getting involved in the distribution and manufacture and why?
• Where is it a problem?
• How can we deal with the problem?

David Shore
Associate Director Global Security Europe
Pfizer

10.00 Falsified Medicines - Whose Problem Is It Anyway?

The outcome of John’s presentation will be to assess and analyse the global market with regards to counterfeit goods and work towards some suggested next steps to really combat the counterfeiters now! John’s talk will include:

• The decline of intellectual property rights and the impact on the pharmaceutical industry
• The struggle for a global consensus, what are the logical next steps? What is the reality in getting this done?
• The responsibility of the pharmaceutical industry, developing an effective working relationship with external bodies
• Key actions for everyone involved to develop industry best practice

John Franks
Security Director EMEA
Merck Sharp & Dohme

10.45 Perspectives From The Frontline; Authentication In Practice

Insight into the true benefits and myths about serialisation and authentication.

Experiences from Aegate, the drug authentication company who have been operating a working authentication system in Europe since 2006. Four years on – what has been learnt? What aspects need to be in place for successful implementation? Plus case study results from a pharmaceutical company who have been using Aegate as part of a public health campaign – what in their view are the real benefits in their experience?

Graham Smith
SVP Business Development
Aegate Ltd

11.45 An Industry Approach - Anti-Counterfeiting At Roche

Each company deals with anti-counterfeiting in a slightly different way employing both external and internal solutions but justifying any expenditure needs to first be analysed in terms of the risk and impact on the business in order to justify expenditure and any measures taken. The talk from Roche includes:

• Assessment of the impact on Roche as a benchmark for your company
• Risk analysis: Best practice steps to identify the risk within your business
• A co-ordinated approach – Anti-counterfeit features, serialisation, analysis of those implemented by Roche
• Handling of counterfeited products, identifying an ideal solution
• Networking with customs and law enforcement authorities. Best practice working relationships

Silvia Fritz
Secretary General of the Global Roche Anti-Counterfeit Commission, F. Hoffmann-La Roche Ltd And Claudius Kreyenbühl, Counterfeit and Complaint Handling, Member of the Global Roche Anti- Counterfeit Commission
F. Hoffmann-La Roche Ltd

12.30 Pharmaceutical Counterfeiting The Reality And The Challenges

The reality of counterfeit goods making it to market, is one that the pharmaceutical industry are combating every day, but the result of the damage on public health is a stark reality faced not only by the pharmaceutical industry, but every single one of us. The seriousness of this reality makes this an issue that cannot be ignored, Andrew assesses the real impact on public health and gives an honest assessment of the factors enabling counterfeit drugs to enter the supply chain, enabling you to identify the areas of most risk, and put in the necessary steps to combat the counterfeiters at these points, specific topics include:

• The public health and economic costs of pharmaceutical counterfeiting
• Examination of the factors facilitating why counterfeit drugs obtain entry into the legitimate distribution system
• The pitfalls of over reliance on technology

Andrew Jackson
Head, Global Corporate Security & Aviation
Novartis

14.30 EFPIA Coding Enforcement: The Trials In Sweden

The majority of individuals are aware of the EFPIA project and a number of the companies involved with the trials. Grant will provide a perspective from one of the companies involved in the project and the successes of the serialisation to date. Identifying the outcomes in these trials early will give participants who aren’t involved in the project a chance to see what serialisation holds for the future. Grant’s talk will include:

• An overview of the serialisation trials and what we have learnt so far
• So we have built the strategy, but how do we know it is right?
• Technology analysis: What is going to really deliver for us with serialisation?
• 2D Data matrix codes with product identification?
• Data handling – Applying the code and when this will be introduced at the pharmacy level

Grant Courtney
Global and European Serialisation Lead
GSK (EFPIA representative)

15.15 Project Blue: The Internet German Customs System – Tracking The Money Route

Key successes of the Project Blue system in deterring and tracking counterfeiters has meant that the Project Blue system is one of the most successful initiatives for tracking the money of counterfeiters. The project has attracted global interest and is supported by a number of corporations, and provides a real solution in dealing with the most common route of counterfeit goods - the internet. Frank’s presentation includes:

• Illegal internet pharmacies, targeted, co-ordinated and co-operative action
• What action is taken and by which governments?
• Project Blue: A potential solution and the success so far

Frank Birkhold
Chief Customs Officer
German Customs

16.30 National Identification Systems Belgium Medicines Control Project: What Contributed to our Success!

Dirk gives an analysis of the system implemented in Belgium and the impact so far this system has had in tracing and seizing counterfeit goods. Conclusions drawn from the successes of this system can translate to others in the industry, enabling this to act as a benchmark for future similar systems. Specific topic discussion included:

• Fighting counterfeit is not new: A brief history of the Belgian Medicines Control Laboratory
• Why would pharmacists be interested in online authentication to fight counterfeit medicines?
• Indispensible building blocks for such a system: What exists and what do we still need?
• There is much more to (bar)coding than meets the eye (as seen by pharmacists)
• How to increase the cost effectiveness of online authentication?

Dirk Broeckx
Secretary-General
APB (Belgian Pharmacists Association)

17.15 Netherlands Pharmaceutical Anti-Counterfeiting: Bureau Of Investigation Partnerships Or Relationships

The relationships between government organisation such as customs departments, regulatory bodies, or bureaus of investigations with the pharmaceutical companies can really affect the success of a strategy to seize goods. However the transfer of information isn’t always as straightforward as it sounds. Key insights into the Netherlands working relationships come from Harry Rotgans:

• Working effectively with the customs department: Effective transfer of information
• Working effectively with the pharmaceutical companies: Building on the existing relationships for a cohesive future approach
• Trends in the current seizures of pharmaceuticals and the conclusions we can draw to effectively direct the future efforts

Harry Rotgans
Chief Healthcare Investigator
Netherlands Bureau of Investigation

18.15 Chair’s Closing Remarks

18.30 Close Of Conference Day One