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Pharmaceutical counterfeiting and fraud pose an enormous problem for the Healthcare industry today. As well as the obvious threat to patient safety, the image, integrity and financial well-being of Pharmaceutical companies is dependent on the control of its products, from manufacture to sale.

With the rapid growth of on-line pharmacies, with the potential to bypass safeguards, coupled with increasingly sophisticated technologies enabling the production of convincing fakes, fraud and counterfeiting is no longer just a problem in developing countries. However, with the help of novel technologies and the implementation of a number of practical management strategies, there seems to be potential to drastically cut the huge number of open cases of counterfeit, diversion, tampering, smuggling and parallel importing reported by the authorities world-wide.

This global Conference will provide a platform for an in depth analysis of the issues and problems experienced by Pharmaceutical companies, Manufacturers, Wholesalers and Distributors, illustrated by specific case studies. It will provide an opportunity for industry personel to meet with regulators, patient representatives and suppliers of viable security and authentication solutions, in order to discuss what can be done to ensure that the product that reaches the consumer is the unadulterated form intended by its producer.

The Conference will identify where the main problems arise and locate where the vunerabilities lie in ensuring a given product meets its market. It will include input from the industry outlining their experiences and successful and less-successful attempts to overcome the problems. The Conference will explore how to couteract the re-boxing or re-branding of pharmaceuticals, drug substitution or drug simulation and look at how possible control solutions might be established and managed. The latest regulatory framework will be reviewed and ideas put forward as to how the industry can work together with regulatory authorities and other parties to combat the increasing problems of counterfeit and fraud.

A unique opportunity to learn from leading industry experts including:

  • Dr Eshetu Wondemagegnehu, Technical Officer& Focal Person for Counterfeit Drugs, World Health Organisation (WHO)
  • Fabiana Lacerca, Legal Affairs, Merck Sharp& Dohme
  • Andrew Jackson, Executive Director & Deputy Head, Global Corporate Security, Novartis
  • Geoff Power, Director, Packaging Security, GlaxoSmithKline
  • Benjamin England, Hogan& Hartson, LLP
  • Jim Gee, Chief Executive, NHS Counter Fraud& Security Management Service
    Benefits of Attending
    • PHARMACEUTICAL COUNTERFEITING& FRAUD: Discover the latest threat to the global pharmaceutical industry
    • COMBATING THE PROBLEM: Learn how current regulations succeed or fail in the fight against fraud and counterfeiting
    • DETECTION& PREVENTION: An insight into the industry's current strategies and solutions
    • EVALUATE PROTECTIVE TECHNOLOGIES: Find out about the latest in anti-counterfeiting technologies from an independent perspective
    • KEY REGULATORY& INDUSTRY PERSONNEL: Meet the leaders in the field

    " A wonderful opportunity to exchange ideas with leading experts in the area of counterfeiting and fraud."
    Fabiana Lacerca, Director, Legal Affairs, Merck Sharp & Dohme

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Benjamin England

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

9:10 KEYNOTE ADDRESS

Dr Eshetu Wondemagegnehu

Dr Eshetu Wondemagegnehu, Technical Officer & Focal Person for Counterfeit Drugs, World Health Organisation (WHO)

  • What are counterfeit drugs?
  • The extent of the problem
  • Types of counterfeit drugs
  • Health impacts
  • Main factors facilitating counterfeit drugs
  • What is WHO doing to address the problem?
    What needs to be done globally to reduce the problem?
  • 9:40 PHARMACEUTICAL COUNTERFEITING, FRAUD & RISK MANAGEMENT

    Benjamin England

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

  • Discussing counterfeiting risk and management
  • Federal counter-terrorism initiatives
  • Impact of federal legislation
  • The Bio-terrorism Preparedness and Response Act of 2000
  • Leveraging GMPs and federal programs into international trade and efficiencies
  • The importance of public/private partnerships for overcoming government inertia
  • 10:20 LIABILITY & ACCOUNTABILITY

    Scott Anthony Farnsworth

    Scott Anthony Farnsworth, Partner, Roiter Zucker

  • Financial liability and the pharmaceutical industry
  • Prescription drugs – strict liability with the producers for costs of lawsuits and fines regardless of any question of negligence with the producers
  • Problems distinguishing between counterfeit and genuine goods - wrongful liability
  • Successful prosecution
  • Encouraging fraud – counterfeiting as a white collar crime
  • Working with investigators and law enforcement
  • insuring against counterfeiting
  • Can the patient be protected?
  • 11:00 Morning Coffee

    11:20 PROTECTING THE HEALTH OF THE POOR IN DEVELOPING COUNTRIES

    Dr Richard Jahnke

    Dr Richard Jahnke, Project Manager, German Pharma Health Fund

  • Dangerous trade in counterfeit medicines
  • Anti-counterfeiting measures on government, industry and supply chain level
  • Global GPHF awareness and information campaign
  • Efforts on establishing national drug quality labs
  • GPHF - Minilab: Simple drug quality verification in the field
  • 12:00 COMBATING FRAUD: AN INSIDE PERSPECTIVE

    Andrew Jackson

    Andrew Jackson, Executive Director & Deputy Head, Global Corporate Security, Novartis International AG

  • Novartis: a case study
  • Vulnerability of products to the problem of counterfeiting
  • Establishing an anti-counterfeiting programme: vision, mission and objectives
  • Importance of protecting the brand
  • Co-operative approaches
  • Current strategies employed to counter fraud
    Pitfalls and false hopes
  • 12:40 Networking Lunch

    13:40 COMBATING PHARMACEUTICAL COUNTERFEITING

    Geoff Power

    Geoff Power, Director, Packaging Security, GlaxoSmithKline

  • Examples of GSK product counterfeiting and diversion
  • The nature and scope of the problems
  • Potential risks to patients
  • Detection and prevention
  • Overt or covert protection?
  • An outline of GSK protective strategy
  • 14:40 REDUCING COUNTERFEIT & SUBSTANDARD DRUGS IN DEVELOPING COUNTRIES

    Fabiana Lacerca

    Fabiana Lacerca, Director, Legal Affairs, Merck Sharp & Dohme

  • Brief history of counterfeiting in Latin America
  • Causes and consequences
  • Coping with fraud
  • Early signs of counterfeits
  • Looking towards the future – proposed changes in legislation and internal procedures
  • 15:20 Afternoon Tea

    15:40 INTERNATIONAL ASPECTS OF COUNTERFEIT DRUGS & STARTING MATERIALS

    Dr Martijn ten Ham

    Dr Martijn ten Ham, Senior Advisor, International Affairs, Netherlands Ministry of Health, Welfare & Sport

  • Consequences of counterfeit drugs
  • Quality control of starting materials for pharmaceutical products
  • European initiatives: European Union, Council of Europe
  • International co-operation
  • 16:20 DETECTION & PREVENTION

    John Allan

    John Allan, Director, Carratu International

  • Causes, consequences and the scale of global pharmaceutical counterfeiting
  • Methods of investigation and detection of counterfeiters
  • The responsibility of manufacturers
  • Strategies for the collation of information and the formation of preventative strategies
  • The future of counterfeiting
  • New protective technologies
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Fabiana Lacerca

    Fabiana Lacerca , Director, Legal Affairs, Merck Sharp & Dohme

    9:10 INTELLIGENCE ANALYSIS

    Chris Jenkins

    Chris Jenkins, Associate Director, Pinkerton Consulting & Investigations

  • Analysis turns raw data into usable intelligence
  • Usable intelligence helps focus investigations
  • Focussed investigations are more cost-effective and are more likely to success
  • Cost-effective, successful investigations and prosecution are the goal
  • 9:40 FIGHTING COUNTERFEITERS

    Danièle Letore

    Danièle Letore, Managing Director, Genevensis

  • The importance of patient education
  • Integrating the message in patient association information
  • Patients and media work
  • Patients and litigation
  • Looking at the future
  • 10:20 COUNTERING FRAUD IN THE NHS

    Jim Gee

    Jim Gee, Chief Executive, NHS Counter Fraud & Security Management Service

  • A comprehensive, professional and integrated approach
  • Combining policy and operational work to reduce losses
  • Overall responsibility with the NHS? Counter Fraud and Security Management Service (NHS CFSMS)
  • Working closely with pharmaceutical stakeholders
  • Using information systems to develop focussed business intelligence systems
  • The bottom line: reducing losses and freeing up resources for better patient care
  • 11:00 Morning Coffee

    11:20 SIMPLE LOW-COST STRATEGIES TO RAPIDLY IDENTIFY COUNTERFEIT DRUGS IN DEVELOPING COUNTRIES

    Michael Green

    Michael Green, Chemist, Center for Disease Control & Prevention

  • Adapting to field conditions
  • Current and proposed techniques
  • Evaluation of a ‘bulk property’ technique
  • Role in drug monitoring and surveys
  • 12:00 FIGHTING THE PROBLEM

    Peter Lowe

    Peter Lowe, Assistant Director, ICC Counterfeiting Intelligence Bureau (CIB)

  • A new approach to help pharmaceutical companies fight the growth in counterfeiting
  • The value of exchanging confidential information on an international level
  • Consumer awareness programmes and education
  • Technologies that protect and authenticate
  • The way forward?
  • 12:40 Networking Lunch

    14:00 CO-OPERATION IN THE FACE OF ADVERSITY

    Gerard Norris

    Gerard Norris, Principal Consultant, Intech Bioscience

  • Can the pharmaceutical industry, healthcare agencies, law enforcers and the government work together to overcome counterfeiting and related fraud?
  • The role of non-governmental organisations in the delivery of international technical, logistical and financial support against counterfeit pharmaceuticals
  • Databases: reports of counterfeit drugs and public information
  • Intersectoral co-operation between NDRAs, law enforcement and customs services: a viable option?
  • International collaboration - in theory and practice
  • Other new and emerging issues
  • 14:40 AUTHENTICATION AT THE POINT OF SALE

    Rob Whewell

    Rob Whewell, Managing Consultant, PA Consulting Group

  • The essence of ‘buyer beware’ philosophy: who is to blame?
  • Care and control: the ability to track products through the distribution chain
  • Manufacturer authentication at the point of sale
  • Technological innovations to combat pharmaceutical fraud allowing product confirmation while you wait
  • The credit card model - the use of holograms as an obstacle for counterfeiting, tampering and diversion
  • 15:20 Afternoon Tea

    15:40 UNDERSTANDING & EVALUATING SECURITY TECHNOLOGIES FOR PHARMACEUTICALS

    Richard Jotcham

    Richard Jotcham, Director, of Technology Services, Axess Technologies

  • Overt, covert and forensic level authentication features
  • Coding and tracking systems
  • Applying technologies to products and packaging
  • Combining authentication, anti-tampering and anti-diversion technologies
  • Comparing pharmaceutical security technologies with other brand protection applications
  • 16:20 BRAND PROTECTING SYSTEMS

    Nigel Williams

    Nigel Williams, UK Agent, Schreiner ProSecure

  • Definitions: threats to the industry and potential areas of danger
  • Key strategic elements of anti-counterfeiting
  • Responsibilities of the brand owners
  • Steps in anti-counterfeiting programmes
  • Experiences in the pharmaceutical industry
  • Examples of solutions in place
    Security features in use (overt, covert, forensic)
    Integration of track & trace solutions
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Internet Pharmacies: Policing the Threat
    Workshop

    Internet Pharmacies: Policing the Threat

    The Hatton, at etc. venues
    8th October 2003
    London, United Kingdom

    Litigation Remedies for Counterfeiting & Fraud in the Pharmaceutical Industry
    Workshop

    Litigation Remedies for Counterfeiting & Fraud in the Pharmaceutical Industry

    The Hatton, at etc. venues
    8th October 2003
    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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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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