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Increases in drug counterfeiting, drug reimportation, and drug diversion are fuelling the need for improved pharmaceutical security measures from manufacturers, distributors, retailers, and regulatory agencies, such as the Food and Drug Administration. Authentication and track and trace technologies offer the possibility of improving pharmaceutical security throughout the supply chain to ensure the safety and integrity of prescription drugs.

The pharmaceutical market lost approximately $2 billion to the sale of counterfeit drugs and an additional $7 billion to drug reimportation in 2003. Unless pharmaceutical stakeholders and regulatory agencies make efforts to improve pharmaceutical security practices, the market could lose up to $68 billion annually to illicit drug practices by 2009.

This report includes in-depth analysis of current trends and challenges in pharmaceutical security, identifies areas within the pharmaceutical supply chain in need of stricter control, and recommends strategic options for companies seeking to improve security measures. The study provides financial assessments of technology implementation with detailed assumptions that quantify the costs and benefits of implementing pharmaceutical security measures.

Hear major contributions from senior representatives including:
· Jim Christian, Global Head, Corporate Security, Novartis
· Ralph Dillon, Director, Quality Engineering, Pfizer
· Joseph Noferi, Director, Compliance & BioPharma QA, Pfizer
· Dr Gabriele Küsters, Director, Corporate Public Affairs, Aventis
· Dr Thomas Zimmer, Corporate Director, Boehringer-Ingelheim
· Robert Moore, Executive Director, Global Security Group, Merck & Co
· Dr Weng Li Yoon, Scientist, GlaxoSmithKline
· Dr Thomas Sharp, Associate Research Fellow, Pfizer
· Dr Lembit Rägo, Coordinator, Quality Assurance & Safety: Medicines, World Health Organisation (WHO)
· Christophe Zimmermann, European Commission, DG TAXUD
· Bertrand Gellie, Director, European Patent Office

The essential event on:
· COUNTERFEIT PHARMACEUTICALS: Hear about counterfeit drugs and their effects around the world
· REGULATIONS & LEGAL FRAMEWORK: Learn about the integrity of the world’s supply chain
· ANTI-COUNTERFEITING STRATEGIES: Understand the regulatory requirements and uses for bar codes
· ANALYTICAL TECHNIQUES: Gain an insight into the use of near-infrared spectroscopy
· INVESTIGATION & ENFORCEMENT: Assess corporate management and response to managing counterfeit events

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Thomas Zimmer

Dr Thomas Zimmer, Corporate Director, Boehringer-Ingelheim

9:10 COMBATING COUNTERFEITS

Dr Thomas Zimmer

Dr Thomas Zimmer, Corporate Director, Boehringer-Ingelheim

  • The five key issues of anti-counterfeiting
  • The key role of lobbying at the stakeholders
  • Common insight and alignment of stakeholders
  • Supply chain control and technical measures
  • Liabilities for pharmaceutical companies
  • Global approach
  • 9:50 COUNTERFEIT PHARMACEUTICALS

    Jan-Peter van Suchtelen

    Jan-Peter van Suchtelen, Director, International Pharma Policy, Organon

  • The problem: why take measures?
  • Protection of public health
  • What can be done?
  • Investigation, communication and co-operation
  • Product protection
  • What is most effective?
  • 10:30 Morning Coffee

    10:50 AN OVERWHELMED SYSTEM

    Dr Lembit Rägo

    Dr Lembit Rägo, Coordinator, Quality Assurance & Safety: Medicines, World Health Organisation (WHO)

  • How big is the problem globally?
  • Targeting those most at risk and in need e.g. HIV, malaria, cancer etc,
  • Targeting life style drugs and "natural medicines"
  • Quality, safety and efficacy of pharmaceuticals circulating in unregulated markets and sold via internet
  • Tackling the problem Globally - missed opportunities or hopeless battle
  • Way forward – increased transparency and co-operation between stakeholders
  • 11:30 INTEGRITY OF THE WORLD’ S SUPPLY CHAIN

    Steven Matz

    Steven Matz, Senior Analyst, Icc International Maritime Bureau

  • How big an issue is this?
  • Initiatives to counter this – is the law being enforced?
  • Where are development agencies and law enforcement agencies going wrong?
  • Economic cost of fraud and counterfeiting
  • Case study: what is happening in China and India?
  • 12:10 THE CONTRIBUTION OF IPRS IN THE REPRESSION OF COUNTERFEIT DRUGS

    Bertrand Gellie

    Bertrand Gellie, Director, European Patent Office

  • Strength and weakness of Patents, Trademarks and Design against counterfeits
  • When counterfeits are also infringing
  • The projects and studies of the Council of Europe
  • Towards a new criminal statute for counterfeit drugs
  • Recommendations and perspectives
  • 12:50 Networking Lunch

    14:10 PARTNERSHIPS IN THE FIGHT AGAINST COUNTERFEIT DRUGS

    Dr Eric Noehrenberg

    Dr Eric Noehrenberg, Director, International Trade & Market Policy, International Federation of Pharmaceutical Manufacturers Associations (IFPMA)

  • Global extent of the counterfeit drugs problem
  • Partnerships among IFPMA, WHO and others to raise awareness of issue and need for action
  • Efforts by the pharmaceutical industry to work with national authorities to fight counterfeits
  • Further steps – who should be brought into partnership and what should be done?
  • 14:50 LEVERAGING RISK MANAGEMENT INTO MARKET AND CONSUMER VALUE

    Benjamin England

    Benjamin England, Attorney, Hogan & Hartson LLP (Former Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, FDA)

  • USFDA and US Customs and Border Protection (CBP) are beginning to discuss reducing the incidents and effects of product counterfeiting, tampering, or fraud by using risk-based models that can be implemented by industry and verified by Government. How might this approach be leveraged into international trade in pharmaceuticals or other consumer goods?
  • Improving your risk management processes should result in more value than simply reducing liability or improving market control – what are you getting from government in exchange for risk management?
  • International effectiveness: third party certification and reduction of screening or inspection by government agencies
  • 15:30 Afternoon Tea

    16:00 EFFICIENT PHARMA PACKAGING SOLUTIONS IN SECURING THE SUPPLY CHAIN

    Thomas Voelcker

    Thomas Voelcker, Managing Director, Schreiner Prosecure

  • New challenges due to counterfeiting, manipulation and diversion
  • Objectives of innovative packaging
  • New solutions in practise
  • Performance criteria of partners in pharma packaging
  • Return-of-investment of security measures
  • 16:40 AUTHENTICATION AT THE POINT OF DISPENSING

    Rob Whewell

    Rob Whewell, Managing Consultant, PA Consulting Group

  • Format of the pilot in the UK
  • Scope and objectives
  • Technology overview
  • Opportunities for patients, pharmacists, wholesalers and manufacturers
  • Timescales
  • Next steps
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Steven Matz

    Steven Matz, Senior Analyst, Icc International Maritime Bureau

    9:10 HARDENING THE SUPPLY CHAIN

    Joseph Noferi

    Joseph Noferi, Director, Compliance & BioPharma QA, Pfizer

  • Lessons of Sun Tsu applied to pharmaceuticals
  • Proactive defence of products and brands
  • Planning and measured reaction to mitigate counterfeit Attacks
  • 9:50 AN INDUSTRY VIEW TOWARD FINANCIAL JUSTIFICATION FOR ANTI-FRAUD/ANTI-COUNTERFEITING

    Ralph Dillon

    Ralph Dillon, Director, Quality Engineering, Pfizer

  • Financial justification (with supportive examples)
  • Cost to sales
  • Indirect costs
  • Direct costs
  • Other advantages/financial paybacks
  • Budget for success
  • 10:50 Morning Coffee

    11:20 ENGINEERING SECURITY INTO THE DOSAGE FORM

    Dr Jim Rittenberg

    Dr Jim Rittenberg, Vice President, Pharmaceuticals, Authentix

  • Security considerations in designing the dosage form
  • Approaches to authenticating the dosage form – overt and covert technologies
  • Insertion and analysis of proprietary trace taggants
  • Regulatory implications
  • Case examples
  • 12:00 DRUG SUBSTANCE AND IMPURITY STRUCTURE IDENTIFICATION

    Dr Thomas Sharp

    Dr Thomas Sharp, Associate Research Fellow, Pfizer

  • The logic involving identification of a counterfeit
  • Impurity identification is a team approach
  • A systematic process for identifying impurities
  • Identification examples
  • 12:40 Networking Lunch

    14:10 MULTI-STABLE ISOTOPIC TRACING OF PHARMACEUTICALS

    Dr John Jasper

    Dr John Jasper, Chief Scientific Officer, Molecular Isotopic Technologies

  • Highly-specific batch-to-batch identification of pharmaceutical components
  • Isotopic fingerprints of active pharmaceutical ingredients, finished dosage forms
  • The technology of stable isotopes: chemistry, instrumentation, probabilities etc
  • Isotopic strategy to mitigate counterfeiting, diversion, theft, vicarious liability and patent infringement
  • Salient features of multi-stable isotopic analysis
  • 14:50 NEAR-INFRARED SPECTROSCOPY

    Dr Weng Li Yoon

    Dr Weng Li Yoon, Scientist, GlaxoSmithKline

  • The use of near-infrared spectroscopy
  • Detecting counterfeit drugs
  • Effectiveness of the technique
  • 15:30 Afternoon Tea

    16:00 ANTI-COUNTERFEITING STRATEGY

    Jim Christian

    Jim Christian, Global Head, Corporate Security, Novartis

  • History
  • Government actions
  • Industry strategy and support
  • Case reviews
  • The future
  • 16:40 CORPORATE MANAGEMENT AND RESPONSE

    Robert Moore

    Robert Moore, Executive Director, Global Security Group, Merck

  • Notification
  • Roles and responsibilities
  • Global co-ordination
  • Investigation
  • Close-out
  • Data management
  • 17:20 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    Developing an Anti-Counterfeiting Strategy
    Workshop

    Developing an Anti-Counterfeiting Strategy

    CBI Conference Centre
    1st December 2004
    London , United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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